Clinical trial • Phase III • Psychiatry

TROSPIUM CHLORIDE; XANOMELINE TARTRATE for Bipolar I disorder (mania or mixed features)

Phase III trial of TROSPIUM CHLORIDE; XANOMELINE TARTRATE for Bipolar I disorder (mania or mixed features).

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Bipolar I disorder (mania or mixed features)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-05-2025
First CTIS Authorization Date
28-08-2025

Trial design

Randomised, placebo (karxt matching placebo); no dose or schedule for comparator stated in the available ctis data-controlled Phase III trial in Sweden, Romania, Croatia and others.

Randomised
Yes
Comparator
Placebo (KarXT Matching Placebo); no dose or schedule for comparator stated in the available CTIS data
Target Sample Size
185
Trial Duration For Participant
21

Eligibility

Recruits 185 No vulnerable populations were selected in the CTIS record. Participants must be adults (18 to 65) and provide informed consent via the ICF; there is no assent procedure described for minors and no vulnerable-population-specific consent handling is provided..

Vulnerable Population
No vulnerable populations were selected in the CTIS record. Participants must be adults (18 to 65) and provide informed consent via the ICF; there is no assent procedure described for minors and no vulnerable-population-specific consent handling is provided.

Inclusion criteria

  • {"criterion_text":"- Participant must be 18 to 65 years of age, inclusive, at the time of signing the ICF.\n- Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2).\n- Individual is experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).\n- The individual requires hospitalization for the acute exacerbation or relapse of mania.\n- All psychotropic medications are washed out in no more than 14 days prior to the first dose of the study drug\n- Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.\n- Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline."}

Exclusion criteria

  • {"criterion_text":"- Any primary DSM-5-TR disorder, other than BP-I with mania or mania with mixed features within 12 months before screening (ie, primary focus of treatment, confirmed using MINI version 7.0.2 at screening), including BP-I with depression (for previous 3 months only), BP-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n- Primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year)\n- Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test\n- Risk for suicidal behavior at screening as determined by the investigator’s clinical assessment and the C-SSRS with an answer “Yes” on items 4 or 5 (C-SSRS – ideation) within 6 months of screening, or \"Yes” to any of 5 items (C-SSRS – behavior) within 12 months of screening or between screening and baseline.\n- History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n- History or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 3.","definition_or_measurement_approach":"Change from baseline in Young Mania Rating Scale (YMRS) score at Week 3; YMRS is used to evaluate manic symptoms."}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 3.","definition_or_measurement_approach":"Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP) at Week 3; CGI-BP used to evaluate daily functioning."}
  • {"endpoint_text":"- Occurrence of TEAEs, SAEs, and TEAEs leading to treatment discontinuation and change in C-SSRS responses during the treatment period.","definition_or_measurement_approach":"Safety endpoints including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to discontinuation, and changes in Columbia-Suicide Severity Rating Scale (C-SSRS) responses during treatment."}
  • {"endpoint_text":"- Change from baseline in BARS, SAS, AIMS, and IPSS (males aged ≥ 45 years only) at Week 3.","definition_or_measurement_approach":"Change from baseline measured at Week 3 for Barnes Akathisia Rating Scale (BARS), Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), and International Prostate Symptom Score (IPSS) (IPSS only for males aged ≥ 45 years)."}

Recruitment

Planned Sample Size
185
Recruitment Window Months
14
Consent Approach
Participants must provide written informed consent via an Informed Consent Form (ICF) prior to participation; participants must be between 18 and 65 years and thus consent themselves. Country-specific ICFs and subject information sheets are available in multiple languages (documents present for English, Spanish, Croatian/HR, Slovak/SK, Swedish/SE and other local language versions). Optional consents for biomarker collection and future research are provided as separate optional ICF documents.

Geography

Total Number Of Sites
21
Total Number Of Participants
185

Sweden

Earliest CTIS Part Ii Submission Date
31-07-2025
Latest Decision Or Authorization Date
28-08-2025
Processing Time Days
28
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Region Stockholm – SLSO
Department Name
Psykiatri Södra Region Stockholm, Lasarettsvägen 6, 131 45 Nacka
Contact Person Name
Andreas Carlborg

Romania

Earliest CTIS Part Ii Submission Date
25-07-2025
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
45
Number Of Sites
10
Number Of Participants
42

Sites

Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
psihiatry
Contact Person Name
Valentin Matei
Contact Person Email
secretariat@spital-obregia.ro
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psihiatry
Contact Person Name
Mihnea Manea
Contact Person Email
secretariat@spital-obregia.ro
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psihiatry
Contact Person Name
Laura Cristina Dolis
Contact Person Email
secretariat@spital-obregia.ro
Site Name
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Department Name
Psihiatry
Contact Person Name
Petru Ifteni
Contact Person Email
relatiicupublicul@spnbrasov.ro
Site Name
Institutul De Psihiatrie Socola Iasi
Department Name
Psihiatry
Contact Person Name
Cristinel Stefanescu
Contact Person Email
sectia5@socola.eu
Site Name
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
Department Name
Psihiatry
Contact Person Name
Traian Barbu
Contact Person Email
cettt_sf.stelian@yahoo.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psihiatry
Contact Person Name
Adela Magdalena Ciobanu
Contact Person Email
secretariat@spital-obregia.ro
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psihiatry
Contact Person Name
Corina Mihaela Nicolae
Contact Person Email
secretariat@spital-obregia.ro
Site Name
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Department Name
Psihiatry
Contact Person Name
Octavian Vasiliu
Contact Person Email
abc@yahoo.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psihiatry
Contact Person Name
Simona Trifu
Contact Person Email
secretariat@spital-obregia.ro

Croatia

Earliest CTIS Part Ii Submission Date
11-08-2025
Latest Decision Or Authorization Date
29-08-2025
Processing Time Days
18
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Klinika za psihijatriju Vrapce
Department Name
Zavod za biologijsku psihijatriju i psihogerijatriju
Contact Person Name
Ninoslav Mimica
Site Name
Clinic for psychiatry Sveti Ivan
Department Name
Psychiatry
Contact Person Name
Igor Filipcic
Contact Person Email
igor.filipcic@kbsvi.hr
Site Name
Klinika za psihijatriju Vrapce
Department Name
Institute for recovery and community support
Contact Person Name
Marko Ćurković
Contact Person Email
bolnica@bolnica-vrapce.hr
Site Name
Klinika za psihijatriju Vrapce
Department Name
Zavod za psihotične poremećaje ženski
Contact Person Name
Miroslav Herceg

Spain

Earliest CTIS Part Ii Submission Date
18-06-2025
Latest Decision Or Authorization Date
29-08-2025
Processing Time Days
72
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Hospital Universitario Basurto
Department Name
Psychiatry
Contact Person Name
Ana Catalán
Contact Person Email
xxxx@xxxx.xx
Site Name
Hospital Clinic De Barcelona
Department Name
Psychiatry and Psychology
Contact Person Name
Eduard Vieta
Contact Person Email
evieta@clinic.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Psychiatry
Contact Person Name
Josep Antoni Ramos-Quiroga
Contact Person Email
jaramos@vhebron.net

Slovakia

Earliest CTIS Part Ii Submission Date
22-08-2025
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
10
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Epamed s.r.o.
Department Name
Psychiatry
Contact Person Name
Eva Palova
Contact Person Email
epamed.ke@gmail.com
Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
Psychiatry
Contact Person Name
Slavka Dubinska
Contact Person Email
slavka.dubinska@unlp.sk
Site Name
Crystal Comfort s.r.o.
Department Name
Psychiatry
Contact Person Name
Dagmar Breznoscakova
Contact Person Email
dbreznoscakova@gmail.com

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
Subject eligibility review/Medical monitoring
Name
Iqvia Inc.
Responsibilities
Site Payments
Name
WCG Clinical Inc.
Responsibilities
COA licensing and translations, Rater training

Third parties

  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Subject eligibility review/Medical monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Sample storage for Biomarker and PK samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA rater station development, eCOA data review, PRO/COA licensing and translations; Rater training","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site Payments","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"PK Analysis","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"COA licensing and translations, Rater training","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Empatica Inc.","duties_or_roles":"Digital biomarker device and software","organisation_type":"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
Authorised (prodAuthStatus=1)
Investigational Product Name
KarXT Matching Placebo
Modality
Other
Combination Treatment
Yes

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