Clinical trial • Phase III • Neurology

TROSPIUM CHLORIDE; XANOMELINE TARTRATE for Psychosis associated with Alzheimer's disease

Phase III trial of TROSPIUM CHLORIDE; XANOMELINE TARTRATE for Psychosis associated with Alzheimer's disease. open-label, none/not specified-controlled.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Psychosis associated with Alzheimer's disease
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
29-09-2023
First CTIS Authorization Date
05-02-2024

Trial design

open-label, none/not specified-controlled Phase III trial across 86 sites in Czechia, Portugal, Slovakia and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
264
Trial Duration For Participant
364

Eligibility

Recruits 264 If a subject is deemed not competent to provide informed consent, the subject’s legally acceptable representative (LAR) must provide informed consent and the subject must provide informed assent. Identified or proxy caregivers (who spend approximately 10 hours/week with the subject) are required and must be willing to attend visits, report on subject status, oversee compliance with medication and study procedures, and participate in study assessments; caregiver/guardian and assent/ICF documents are provided..

Pregnancy Exclusion
6. Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of IMP. Sperm donation is not allowed for 30 days after the final dose of the IMP. A female subject is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). For the definition and list of highly effective methods of contraception, see full protocol/Appendix 1
Vulnerable Population
If a subject is deemed not competent to provide informed consent, the subject’s legally acceptable representative (LAR) must provide informed consent and the subject must provide informed assent. Identified or proxy caregivers (who spend approximately 10 hours/week with the subject) are required and must be willing to attend visits, report on subject status, oversee compliance with medication and study procedures, and participate in study assessments; caregiver/guardian and assent/ICF documents are provided.

Inclusion criteria

  • {"criterion_text":"- 1.\tMust have completed study KAR-031, KAR-032, CN0120056 or CN0120056\n- 2.\tSubject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent KAR-031, KAR-032 study or CN0120056 study\n- 3. Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are performed. If the subject is deemed not competent to provide IC, both the following requirements for consent must be met: a. The subject’s legally acceptable representative (LAR) must provide IC b. The subject must provide informed assent\n- 4.\tAt entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject’s participation in the study.\n- 5.\tCapable of self-locomotion (alone or with the aid of an assistive device) and have an identified or proxy caregiver (who spends approximately 10 hours/week with the subject) that is willing to: a.\tAttend all visits and report on subject’s status b.\tOversee subject compliance with medication and study procedures c.\tParticipate in the study assessments and provide IC to participate in the study\n- 6.\tFemale subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of IMP. Sperm donation is not allowed for 30 days after the final dose of the IMP. A female subject is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). For the definition and list of highly effective methods of contraception, see full protocol/Appendix 1"}

Exclusion criteria

  • {"criterion_text":"- 1.\tSignificant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results\n- 2.\tPsychotic symptoms that are primarily attributable to a condition other than the AD causing dementia, e.g., schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features\n- 3.\tHistory of major depressive episode with psychotic features during the 12 months prior to Screening (Visit 1)\n- 4.\tHistory of a diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder\n- 5.\tSignificant or severe renal impairment based on a screening cutoff for estimated glomerular filtration rate (eGFR) of < 50 mL/min/1.73 m2\n- 6.\tHistory of ischemic stroke within 12 months prior to Screening (Visit 1) or any evidence of hemorrhagic stroke\n- 7.\tHistory of CAA, epilepsy, CNS neoplasm, unstable thyroid function, or unexplained syncope\n- 8.\tAny of the following: a.\tNew York Heart Association (NYHA) Class 2 or greater congestive heart failure; b.\tGrade 2 or greater angina pectoris; c.\tHistory of sustained ventricular tachycardia ; d.\tHistory of ventricular fibrillation; e.\tHistory of torsade de pointes; f.\tHistory of implantable cardiac defibrillator\n- 9. Myocardial infarction within the 6 months prior to Screening (Visit 1)\n- 10.\tPersonal or family history of symptoms of long QT syndrome as evaluated by the Investigator\n- 11.\tExperienced any significant AEs due to trospium, including a known hypersensitivity to trospium\n- 12.\tAny clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study KAR-031 (Visit 19), study KAR-032 (Visit 12), or Study CN0120056 (Visit 12) that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject\n- 13.\tIf, in the opinion of the Investigator and/or Sponsor/Medical Monitor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator and/or Sponsor/ Medical Monitor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements\n- 14. Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033.\n- 15.\tHIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history or LFT results\n- 16.\tHistory or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator\n- 17.\tFor males only, any one of the following: a.\tHistory of bladder stones; b.\tHistory of recurrent urinary tract infections; c.\tSerum prostate specific antigen (PSA) >10 ng/mL at Screening (Visit 1); d.\tAn International Prostate Symptom Score (IPSS) of 5 (almost always) on items 1, 3, 5, or 6; e.\tA sum of scores on IPSS items 1, 3, 5, and 6 of ≥9\n- 18.\tHistory of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months\n- 19.\tRisk of suicidal ideation and behavior during the study as determined by the Investigator’s clinical assessment and/ or C-SSRS at Visit 19 in study KAR-031 or Visit 12 in study KAR-032 or Visit 12 in study CN0120056 as confirmed by the following: a.\tAnswers “Yes” on items 3, 4 or 5 (C-SSRS – ideation) ; b.\tAnswers “Yes” to any of the 5 items (C-SSRS behavior)\n- 20.\tUrine toxicology screen is positive for substances other than cannabis or benzodiazepines (both cannabis and short- or medium-acting benzodiazepines are allowed in limited quantities during the study) unless approval has been given by the Medical Monitor\n- 21.\tUnable to taper and discontinue a concomitant medication that would preclude participation in this study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of TEAEs","definition_or_measurement_approach":"Incidence measured as counts of treatment-emergent adverse events (TEAEs) reported during the study per protocol safety reporting procedures."}

Secondary endpoints

  • {"endpoint_text":"- Incidence of serious TEAEs","definition_or_measurement_approach":"Incidence measured as counts of serious treatment-emergent adverse events (TEAEs) reported during the study."}
  • {"endpoint_text":"- Incidence of TEAEs leading to discontinuation of IMP","definition_or_measurement_approach":"Incidence measured as counts of TEAEs that result in discontinuation of the investigational medicinal product (IMP)."}

Recruitment

Planned Sample Size
264
Recruitment Window Months
27
Consent Approach
Signed informed consent required prior to any study assessments. If subject is not competent to provide informed consent, the subject’s legally acceptable representative (LAR) must provide informed consent and the subject must provide informed assent. Caregiver/partner consent and caregiver involvement are required (identified or proxy caregiver spending ~10 hours/week). Participant information sheets, main ICF, caregiver ICF, assent, guardian and GDPR ICFs are available and provided in country- and language-specific versions (documents in Czech, Portuguese, Slovak, Bulgarian, French, Spanish, Italian, German, Hungarian, Polish, Croatian, Romanian and English are present in the dossier).

Geography

Total Number Of Sites
86
Total Number Of Participants
264

Czechia

Earliest CTIS Part Ii Submission Date
09-01-2024
Latest Decision Or Authorization Date
07-02-2024
Processing Time Days
29
Number Of Sites
5
Number Of Participants
33

Sites

Site Name
Vestra Clinics s.r.o.
Principal Investigator Name
Ladislav Pazdera
Principal Investigator Email
pazdera@neurol.cz
Contact Person Name
Ladislav Pazdera
Contact Person Email
pazdera@neurol.cz
Site Name
Neuroterapie KH s.r.o.
Principal Investigator Name
Slavomír Pietrucha
Principal Investigator Email
slavomir.pietrucha@seznam.cz
Contact Person Name
Slavomír Pietrucha
Contact Person Email
slavomir.pietrucha@seznam.cz
Site Name
A-Shine s.r.o.
Principal Investigator Name
Luboš Janů
Principal Investigator Email
lubos.janu@seznam.cz
Contact Person Name
Luboš Janů
Contact Person Email
lubos.janu@seznam.cz
Site Name
Clinoxus s.r.o.
Principal Investigator Name
Michaela Klementová
Principal Investigator Email
michaela.klementova@gmail.com
Contact Person Name
Michaela Klementová
Contact Person Email
michaela.klementova@gmail.com
Site Name
Clintrial s.r.o.
Principal Investigator Name
Zdeněk Šolle
Principal Investigator Email
zdenek.solle@clintrial.cz
Contact Person Name
Zdeněk Šolle
Contact Person Email
zdenek.solle@clintrial.cz

Portugal

Earliest CTIS Part Ii Submission Date
24-04-2025
Latest Decision Or Authorization Date
23-06-2025
Processing Time Days
60
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Principal Investigator Name
Luisa Alves
Principal Investigator Email
calves@ulslo.min-saude.pt
Contact Person Name
Luisa Alves
Contact Person Email
calves@ulslo.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Unidade Local De Saude De Santa Maria E.P.E.
Principal Investigator Name
Ana Verdelho
Principal Investigator Email
averdelho@medicina.ulisboa.pt
Contact Person Name
Ana Verdelho
Contact Person Email
averdelho@medicina.ulisboa.pt
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Unidade Local De Saude De Matosinhos E.P.E.
Principal Investigator Name
Vitor Tedim Cruz
Principal Investigator Email
vitor.tedimcruz@ulsm.minsaude.pt
Contact Person Name
Vitor Tedim Cruz
Site Name
CNS Saude Lda.
Department Name
CNS Saude Lda.
Principal Investigator Name
Camila Nóbrega
Principal Investigator Email
amila.r.nobrega@gmail.com
Contact Person Name
Camila Nóbrega
Contact Person Email
amila.r.nobrega@gmail.com
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Unidade Local De Saude Do Alto Ave E.P.E.
Principal Investigator Name
Joana Meireles
Principal Investigator Email
joanameireles@ulsaave.minsaude.pt
Contact Person Name
Joana Meireles

Slovakia

Earliest CTIS Part Ii Submission Date
12-12-2023
Latest Decision Or Authorization Date
11-04-2024
Processing Time Days
121
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
MUDr. Beata Dupejova neurologicka ambulancia s.r.o.
Department Name
Neurologická ambulancia
Principal Investigator Name
Beáta Dupejová
Principal Investigator Email
dupejova@gmail.com
Contact Person Name
Beáta Dupejová
Contact Person Email
dupejova@gmail.com
Site Name
Psychiatricka Nemocnica Philippa Pinela Pezinok
Department Name
Neuropsychiatrická klinika SZU a PNPP
Principal Investigator Name
Ján Benetin
Principal Investigator Email
ema@pnpp.sk
Contact Person Name
Ján Benetin
Contact Person Email
ema@pnpp.sk
Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
Psychiatrická klinika
Principal Investigator Name
Dr. Slávka Dubinská
Principal Investigator Email
slavka.dubinska@unlp.sk
Contact Person Name
Dr. Slávka Dubinská
Contact Person Email
slavka.dubinska@unlp.sk
Site Name
Konzilium s.r.o.
Department Name
Neurologicka ambulancia
Principal Investigator Name
Magdalena Perichtova
Principal Investigator Email
perichtova.md@gmail.com
Contact Person Name
Magdalena Perichtova
Contact Person Email
perichtova.md@gmail.com
Site Name
Epamed s.r.o.
Department Name
Psychiatrická ambulancia
Principal Investigator Name
Eva Pálová
Principal Investigator Email
palovae@hotmail.com
Contact Person Name
Eva Pálová
Contact Person Email
palovae@hotmail.com
Site Name
Crystal Comfort s.r.o.
Department Name
Psychiatrická ambulancia
Principal Investigator Name
Dagmar Breznoščáková
Principal Investigator Email
dbreznoscakova@gmail.com
Contact Person Name
Dagmar Breznoščáková
Contact Person Email
dbreznoscakova@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
08-07-2024
Processing Time Days
11
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
Neurology
Principal Investigator Name
Frederik Clement
Principal Investigator Email
frederik.clement@azdelta.be
Contact Person Name
Frederik Clement
Contact Person Email
frederik.clement@azdelta.be
Site Name
UZ Brussel
Department Name
Geriatrics
Principal Investigator Name
Siddharta Lieten
Principal Investigator Email
siddhartha.lieten@uzbrussel.be
Contact Person Name
Siddharta Lieten
Contact Person Email
siddhartha.lieten@uzbrussel.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Neurology
Principal Investigator Name
Frederik Vanhee
Principal Investigator Email
Frederik.vanhee@azgroeninge.be
Contact Person Name
Frederik Vanhee
Contact Person Email
Frederik.vanhee@azgroeninge.be
Site Name
Anima
Department Name
Psychiatry
Principal Investigator Name
Erik Buntinx
Principal Investigator Email
erik.buntinx@anima-alken.be
Contact Person Name
Erik Buntinx
Contact Person Email
erik.buntinx@anima-alken.be

Hungary

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
32
Number Of Sites
6
Number Of Participants
21

Sites

Site Name
Eszak-Budai Szent Janos Centrumkorhaz
Department Name
Budai Családközpontú Lelki Egészség Centrum
Principal Investigator Name
Tamás Kurimay
Principal Investigator Email
tamas.kurimay@janoskorhaz.hu
Contact Person Name
Tamás Kurimay
Contact Person Email
tamas.kurimay@janoskorhaz.hu
Site Name
Semmelweis University
Principal Investigator Name
János Réthelyi
Principal Investigator Email
rethelyi.janos@med.semmelweis-univ.hu
Contact Person Name
János Réthelyi
Site Name
University Of Szeged
Department Name
Pszichiátriai Klinika
Principal Investigator Name
Magdolna Pakaski
Principal Investigator Email
magdolna.pakaski@gmail.com
Contact Person Name
Magdolna Pakaski
Contact Person Email
magdolna.pakaski@gmail.com
Site Name
PsychoTech Kft.
Principal Investigator Name
Viktor Voros
Principal Investigator Email
viktor.voros@psychotech.hu
Contact Person Name
Viktor Voros
Contact Person Email
viktor.voros@psychotech.hu
Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Principal Investigator Name
Attila Valikovics
Principal Investigator Email
valikovics.idegtox@bazmkorhaz.hu
Contact Person Name
Attila Valikovics
Site Name
Gyoengyosi Bugat Pal Koerhaz
Department Name
Department of Psychiatric Rehabilitation
Principal Investigator Name
Tibor Kelemen
Principal Investigator Email
tibor.kelemen.clinexpert@gmail.com
Contact Person Name
Tibor Kelemen

Bulgaria

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
07-02-2024
Processing Time Days
13
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Medical Center Medconsult Pleven OOD
Principal Investigator Name
Maria Aleksandrova
Principal Investigator Email
doc_maria_aleksandrova@abv.bg
Contact Person Name
Maria Aleksandrova
Contact Person Email
doc_maria_aleksandrova@abv.bg
Site Name
Medical Center Hera EOOD
Principal Investigator Name
Plamen Antimov
Principal Investigator Email
plamen.antimov@gmail.com
Contact Person Name
Plamen Antimov
Contact Person Email
plamen.antimov@gmail.com
Site Name
Medical Center Saint Naum EOOD
Principal Investigator Name
Assen Karadaliev
Principal Investigator Email
karadaliev@hotmail.com
Contact Person Name
Assen Karadaliev
Contact Person Email
karadaliev@hotmail.com
Site Name
University Multiprofessional Hospital For Active Treatment Kanev AD
Department Name
Department of General and Vascular Neurology
Principal Investigator Name
Neli Petrova
Principal Investigator Email
npetrova27@gmail.com
Contact Person Name
Neli Petrova
Contact Person Email
npetrova27@gmail.com
Site Name
Medical Center Intermedica Ltd.
Principal Investigator Name
Toni Donchev
Principal Investigator Email
tonyd@abv.bg
Contact Person Name
Toni Donchev
Contact Person Email
tonyd@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Neurology Clinic
Principal Investigator Name
Penka Atanasova
Principal Investigator Email
prof.penka.atanasova@gmail.com
Contact Person Name
Penka Atanasova
Contact Person Email
prof.penka.atanasova@gmail.com
Site Name
Medical Center Medica 2005 EOOD
Principal Investigator Name
Plamen Tsvetanov
Principal Investigator Email
tzvetanovplamen@hotmail.com
Contact Person Name
Plamen Tsvetanov
Contact Person Email
tzvetanovplamen@hotmail.com

Greece

Earliest CTIS Part Ii Submission Date
30-04-2024
Latest Decision Or Authorization Date
30-07-2024
Processing Time Days
91
Number Of Sites
7
Number Of Participants
48

Sites

Site Name
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department Name
University Psychiatric Clinic
Principal Investigator Name
Georgios Alevizopoulos
Principal Investigator Email
galev@nurs.uoa.gr
Contact Person Name
Georgios Alevizopoulos
Contact Person Email
galev@nurs.uoa.gr
Site Name
Henry Dunant Hospital Center
Department Name
B’ Neurology Clinic
Principal Investigator Name
Konstantina Yiannopoulou
Principal Investigator Email
Konstantina.giannopoulou@dunant.gr
Contact Person Name
Konstantina Yiannopoulou
Site Name
University General Hospital Of Heraklion
Department Name
Neurology Clinic
Principal Investigator Name
Ioannis Zaganas
Principal Investigator Email
zaganas@uoc.gr
Contact Person Name
Ioannis Zaganas
Contact Person Email
zaganas@uoc.gr
Site Name
Diagnostic & Therapeutic Center of Athens HYGEIA Single Member S.A.
Department Name
Department of Neurodegenerative Brain Diseases & Memory Clinic
Principal Investigator Name
Paraskevi Sakka
Principal Investigator Email
degen.brain@hygeia.gr
Contact Person Name
Paraskevi Sakka
Contact Person Email
degen.brain@hygeia.gr
Site Name
424 General Military Training Hospital
Department Name
Outpatient Psychiatric Department
Principal Investigator Name
Petros Fotiadis
Principal Investigator Email
petrofotiadis@gmail.com
Contact Person Name
Petros Fotiadis
Contact Person Email
petrofotiadis@gmail.com
Site Name
Athens Naval Hospital
Department Name
Neurology Clinic
Principal Investigator Name
Triantafyllos Doskas
Principal Investigator Email
doskastr@gmail.com
Contact Person Name
Triantafyllos Doskas
Contact Person Email
doskastr@gmail.com
Site Name
University General Hospital Attikon
Department Name
B’ Psychiatry Dept
Principal Investigator Name
Nikolaos Smyrnis
Principal Investigator Email
smyrnis@med.uoa.gr
Contact Person Name
Nikolaos Smyrnis
Contact Person Email
smyrnis@med.uoa.gr

Romania

Earliest CTIS Part Ii Submission Date
11-07-2025
Latest Decision Or Authorization Date
11-08-2025
Processing Time Days
31
Number Of Sites
5
Number Of Participants
1

Sites

Site Name
Institutul Privat de Cercetari Melchisedec pentru Boli Autoimune, Ereditare și Rare – I.P.C.M.
Department Name
Phychiatry
Principal Investigator Name
George-Mihai Badescu
Principal Investigator Email
georgebadescu2000@yahoo.com
Contact Person Name
George-Mihai Badescu
Contact Person Email
georgebadescu2000@yahoo.com
Site Name
CMI Dr. Buhas Ramocea Elena Daniela – Cabinet Medical de Psihiatrie
Department Name
Phychiatry
Principal Investigator Name
Elena Daniela Buhas Ramocea
Principal Investigator Email
elenabuhas@yahoo.com
Contact Person Name
Elena Daniela Buhas Ramocea
Contact Person Email
elenabuhas@yahoo.com
Site Name
Spitalul Clinic Cai Ferate Constanta
Department Name
Neurology
Principal Investigator Name
Ana-Maria Ionescu
Principal Investigator Email
anaiulius@yahoo.com
Contact Person Name
Ana-Maria Ionescu
Contact Person Email
anaiulius@yahoo.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Centrul de Sanatate Mintala
Principal Investigator Name
Mihaela-Cleopatra Rosca
Principal Investigator Email
mihaelarosca@gmail.com
Contact Person Name
Mihaela-Cleopatra Rosca
Contact Person Email
mihaelarosca@gmail.com
Site Name
Carpe Diem S.R.L.
Department Name
Phychiatry
Principal Investigator Name
Cosmina Muntean
Principal Investigator Email
97cosmina@gmail.com
Contact Person Name
Cosmina Muntean
Contact Person Email
97cosmina@gmail.com

France

Earliest CTIS Part Ii Submission Date
15-12-2023
Latest Decision Or Authorization Date
07-02-2024
Processing Time Days
54
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
CHU de Nice, Institut Claude Pompidou Centre Mémoire de Ressources et de Recherche (CM2R)
Principal Investigator Name
Guillaume SACCO
Principal Investigator Email
sacco.g@chu-nice.fr
Contact Person Name
Guillaume SACCO
Contact Person Email
sacco.g@chu-nice.fr
Site Name
Hospital Maison Blanche
Department Name
Département de Médecine interne et de Gérontologie clinique
Principal Investigator Name
Jean-Luc Novella
Principal Investigator Email
jlnovella@chu-reims.fr
Contact Person Name
Jean-Luc Novella
Contact Person Email
jlnovella@chu-reims.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
CHRU de Tours, Centre Mémoire Ressources et Recherche (CMRR)
Principal Investigator Name
Thomas DESMIDT
Principal Investigator Email
t.desmidt@chu-tours.fr
Contact Person Name
Thomas DESMIDT
Contact Person Email
t.desmidt@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
CHU de Toulouse, Hôpital La Grave, Centre de Recherche, Clinique du Gérontopôle
Principal Investigator Name
Maria-Eugenia SOTO-MARTIN
Principal Investigator Email
soto-martin.me@chu-toulouse.fr
Contact Person Name
Maria-Eugenia SOTO-MARTIN
Contact Person Email
soto-martin.me@chu-toulouse.fr
Site Name
CHU De Rouen
Department Name
Département de Neurologie
Principal Investigator Name
David Wallon
Principal Investigator Email
david.wallon@chu-rouen.fr
Contact Person Name
David Wallon
Contact Person Email
david.wallon@chu-rouen.fr

Croatia

Earliest CTIS Part Ii Submission Date
09-01-2024
Latest Decision Or Authorization Date
08-04-2024
Processing Time Days
90
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Clinic for psychiatry Sveti Ivan
Department Name
Clinic for Psyciatry
Principal Investigator Name
Igor Filipcic
Principal Investigator Email
igor.filipcic@pbsvi.hr
Contact Person Name
Igor Filipcic
Contact Person Email
igor.filipcic@pbsvi.hr
Site Name
Poliklinika Neuron
Department Name
Department for Clinical Trials
Principal Investigator Name
Neven Henigsberg
Principal Investigator Email
neven.henigserg@zg.ht.hr
Contact Person Name
Neven Henigsberg
Contact Person Email
neven.henigserg@zg.ht.hr
Site Name
Klinika za psihijatriju Vrapce
Department Name
Department for Biological Psychiatry and Psychogeriatrics
Principal Investigator Name
Ninoslav Mimica
Principal Investigator Email
ninoslav.mimica@bolnica-vrapce.hr
Contact Person Name
Ninoslav Mimica
Site Name
Poliklinika BONIFARM
Department Name
Neurology
Principal Investigator Name
Antonija Vuksic
Principal Investigator Email
antonijabilusic@gmail.com
Contact Person Name
Antonija Vuksic
Contact Person Email
antonijabilusic@gmail.com
Site Name
KBC Zagreb
Department Name
Neurology department
Principal Investigator Name
Natasa Klepac
Principal Investigator Email
natasa.klepac@kbc-zagreb.hr
Contact Person Name
Natasa Klepac
Contact Person Email
natasa.klepac@kbc-zagreb.hr

Italy

Earliest CTIS Part Ii Submission Date
30-01-2024
Latest Decision Or Authorization Date
06-02-2024
Processing Time Days
7
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O. Clinica della Memoria
Principal Investigator Name
Camillo Marra
Principal Investigator Email
camillo.marra@policlinicogemelli.it
Contact Person Name
Camillo Marra
Site Name
Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli
Department Name
Alzheimer and Rehabilitation
Principal Investigator Name
Stefania Orini
Principal Investigator Email
sorini@fatebenefratelli.eu
Contact Person Name
Stefania Orini
Contact Person Email
sorini@fatebenefratelli.eu
Site Name
Azienda Sanitaria Locale Della Provincia Di Biella
Department Name
SOC Neurologia
Principal Investigator Name
Graziano Gusmaroli
Principal Investigator Email
graziano.gusmaroli@aslbi.piemonte.it
Contact Person Name
Graziano Gusmaroli
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Department of Human Neuroscience
Principal Investigator Name
Giuseppe Bruno
Principal Investigator Email
giuseppe.bruno@uniroma1.it
Contact Person Name
Giuseppe Bruno
Contact Person Email
giuseppe.bruno@uniroma1.it
Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
UOC Neurologia
Principal Investigator Name
Marianna Amboni
Principal Investigator Email
mamboni@unisa.it
Contact Person Name
Marianna Amboni
Contact Person Email
mamboni@unisa.it
Site Name
Istituto Auxologico Italiano
Department Name
Department of Neurology
Principal Investigator Name
Nicola Ticozzi
Principal Investigator Email
n.ticozzi@auxologico.it
Contact Person Name
Nicola Ticozzi
Contact Person Email
n.ticozzi@auxologico.it
Site Name
Azienda Ospedaliera Sant'Andrea
Department Name
Dipartimento NESMOS
Principal Investigator Name
Franco Giubilei
Principal Investigator Email
franco.giubilei@uniroma1.it
Contact Person Name
Franco Giubilei
Contact Person Email
franco.giubilei@uniroma1.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
S.C. Neurologia
Principal Investigator Name
Giovanna Zamboni
Principal Investigator Email
giovanna.zamboni@unimore.it
Contact Person Name
Giovanna Zamboni
Contact Person Email
giovanna.zamboni@unimore.it

Poland

Earliest CTIS Part Ii Submission Date
03-07-2024
Latest Decision Or Authorization Date
30-07-2024
Processing Time Days
27
Number Of Sites
11
Number Of Participants
47

Sites

Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Department Name
Oddzial Psychiatryczny i Leczenia Stresu Bojowego
Principal Investigator Name
Tomasz Adamowski
Principal Investigator Email
tadamowski@4wsk.pl
Contact Person Name
Tomasz Adamowski
Contact Person Email
tadamowski@4wsk.pl
Site Name
Pro Salus Sp. z o.o. sp.k.
Principal Investigator Name
Łukasz Jasek
Principal Investigator Email
lukaszjjasek@gmail.com
Contact Person Name
Łukasz Jasek
Contact Person Email
lukaszjjasek@gmail.com
Site Name
Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych Im. Ksiedza Henryka Kardynala Gulbinowicza Osrodek Alzheimerowski Sp. z o.o.
Principal Investigator Name
Izabela Winkel
Principal Investigator Email
i.winkel@me.pl
Contact Person Name
Izabela Winkel
Contact Person Email
i.winkel@me.pl
Site Name
Silmedic Sp. z o.o.
Principal Investigator Name
Ilona Palka-Kisielowska
Principal Investigator Email
ikisielowska@silmedic.pl
Contact Person Name
Ilona Palka-Kisielowska
Contact Person Email
ikisielowska@silmedic.pl
Site Name
Przychodnia Srodmiescie Sp. z o.o.
Principal Investigator Name
Izabela Fadel
Principal Investigator Email
za07@o2.pl
Contact Person Name
Izabela Fadel
Contact Person Email
za07@o2.pl
Site Name
Medycyna Milorzab Sp. z o.o.
Principal Investigator Name
Jakub Kaźmierski
Principal Investigator Email
jakub.kazmierski@umed.lodz.pl
Contact Person Name
Jakub Kaźmierski
Contact Person Email
jakub.kazmierski@umed.lodz.pl
Site Name
Clinical Medical Research Sp. z o.o.
Principal Investigator Name
Anna Szczegielniak
Contact Person Name
Anna Szczegielniak
Site Name
Centrum Medyczne Hcp Sp. z o.o.
Department Name
Ośrodek Badań Klinicznych Oddzial Udarowy i Neurologii
Principal Investigator Name
Przemyslaw Osip
Principal Investigator Email
przemyslaw.osip@cmhcp.pl
Contact Person Name
Przemyslaw Osip
Contact Person Email
przemyslaw.osip@cmhcp.pl
Site Name
Osrodek Badan Klinicznych Bd Research Sp. z o.o.
Principal Investigator Name
Elzbieta Wagenknecht
Principal Investigator Email
elzbieta.wagenknecht@bdresearch.com.pl
Contact Person Name
Elzbieta Wagenknecht
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
Principal Investigator Name
Marcin Nastaj
Principal Investigator Email
marcinnastaj@gmail.com
Contact Person Name
Marcin Nastaj
Contact Person Email
marcinnastaj@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne
Principal Investigator Name
Adam Włodarczyk
Principal Investigator Email
aswlodawczyk@gmail.com
Contact Person Name
Adam Włodarczyk
Contact Person Email
aswlodawczyk@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
19-10-2023
Latest Decision Or Authorization Date
07-02-2024
Processing Time Days
111
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Hospital Clinico San Carlos
Department Name
Neurology
Principal Investigator Name
Jordi Matias-Guiu Antem
Principal Investigator Email
jordi.matias-guiu@salud.madrid.org
Contact Person Name
Jordi Matias-Guiu Antem
Site Name
Hospital Universitario De Salamanca
Department Name
Neurology. Centro de Salud San Juan
Principal Investigator Name
Angel Luis Montejo Gonzalez
Principal Investigator Email
amontejo@usal.es
Contact Person Name
Angel Luis Montejo Gonzalez
Contact Person Email
amontejo@usal.es
Site Name
Hospital Victoria Eugenia De La Cruz Roja Espanola
Department Name
Neurology
Principal Investigator Name
Felix Viñuela Fernandez
Principal Investigator Email
fvinuela@us.es
Contact Person Name
Felix Viñuela Fernandez
Contact Person Email
fvinuela@us.es
Site Name
Clinica Montecanal S.L.
Department Name
Neurology
Principal Investigator Name
Antonio Oliveros-Cid
Principal Investigator Email
neuropolis.science+KAR033@gmail.com
Contact Person Name
Antonio Oliveros-Cid
Site Name
Hospital Universitario Rio Hortega
Department Name
Psychiatry
Principal Investigator Name
Juan Luis Muñoz Sanchez
Principal Investigator Email
jlmusa@icloud.com
Contact Person Name
Juan Luis Muñoz Sanchez
Contact Person Email
jlmusa@icloud.com
Site Name
Complejo Asistencial De Zamora Hospital Provincial De Zamora
Department Name
Psychiatry
Principal Investigator Name
Manuel Angel Franco Martin
Principal Investigator Email
mfrancom@saludcastillayleon.es
Contact Person Name
Manuel Angel Franco Martin
Contact Person Email
mfrancom@saludcastillayleon.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Neurology
Principal Investigator Name
Pilar Sanchez Alonso
Principal Investigator Email
pisanchezal@gmail.com
Contact Person Name
Pilar Sanchez Alonso
Contact Person Email
pisanchezal@gmail.com
Site Name
Hospital Quironsalud Malaga
Department Name
Neurology
Principal Investigator Name
Jesus Manuel Romero Imbroda
Principal Investigator Email
j.imbroda.eecc@medicalimbrain.com
Contact Person Name
Jesus Manuel Romero Imbroda

Germany

Earliest CTIS Part Ii Submission Date
17-11-2023
Latest Decision Or Authorization Date
05-02-2024
Processing Time Days
80
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Studienzentrum Dr. Bischof GmbH
Principal Investigator Name
Felix Bischof
Principal Investigator Email
felix.bischof@me.com
Contact Person Name
Felix Bischof
Contact Person Email
felix.bischof@me.com
Site Name
Goethe University Frankfurt
Department Name
Klinik für Psychiatrie, Psychosomatik und Psychotherapie
Principal Investigator Name
Andreas Reif
Principal Investigator Email
reif@med.uni-frankfurt.de
Contact Person Name
Andreas Reif
Contact Person Email
reif@med.uni-frankfurt.de
Site Name
Neuro Centrum Science GmbH
Department Name
N/A - private practice
Principal Investigator Name
Gerd Reifschneider
Principal Investigator Email
g.reifschneider@neuro-centrum-science.de
Contact Person Name
Gerd Reifschneider
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Psychiatrie und Psychotherapie
Principal Investigator Name
Matthias Riemenschneider
Principal Investigator Email
matthias.riemenschneider@uks.eu
Contact Person Name
Matthias Riemenschneider

Sponsor

Primary sponsor

Full Name
Karuna Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Pharmaceutical Product Development LLC
Responsibilities
code:4
Name
PPD Development LP
Responsibilities
codes:1,11,12,13,2,3,4,5,6,7,8,9
Name
PPD Global Ltd.
Responsibilities
codes:1,12
Name
PPD Global Central Labs
Responsibilities
code:4
Name
Veristat LLC
Responsibilities
code:10
Name
Medidata Solutions Inc.
Responsibilities
code:7

Third parties

  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Travel Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Travel Reimbursement, Patient transport management, reimbursement, stipend management","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Quanterix Corp.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Mayo Collaborative Services LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Veristat LLC","duties_or_roles":"code:10","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac safety management, ECG safety","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes:1,11,12,13,2,3,4,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOAs and rater qualification, scales management","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"codes:1,12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
KarXT
Active Substance
TROSPIUM CHLORIDE; XANOMELINE TARTRATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Not approved in any country worldwide at time of application
Combination Treatment
Yes

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