Clinical trial • Phase III • Neurology|Rare Disease

BEXICASERIN HYDROCHLORIDE for Dravet syndrome | Severe myoclonic epilepsy of infancy

Phase III trial of BEXICASERIN HYDROCHLORIDE for Dravet syndrome | Severe myoclonic epilepsy of infancy.

Overview

Trial Therapeutic Area
Neurology|Rare Disease
Trial Disease
Dravet syndrome | Severe myoclonic epilepsy of infancy
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
18-12-2024
First CTIS Authorization Date
30-04-2025

Trial design

Randomised, placebo comparator: lp352 (bexicaserin) placebo oral solution — matching placebo administered orally or via g-tube/percutaneous endoscopic gastrostomy (peg) tube. experimental arm: lp352 (bexicaserin) oral solution, titrated up to the highest tolerated dose during the titration period (specific dose titration schedule described in protocol; maximum daily dose amount recorded as 36 mg in product data).-controlled, adaptive Phase III trial across 39 sites in Italy, Latvia, Belgium and others.

Randomised
Yes
Comparator
Placebo Comparator: LP352 (bexicaserin) Placebo Oral Solution — matching placebo administered orally or via G-tube/percutaneous endoscopic gastrostomy (PEG) tube. Experimental arm: LP352 (bexicaserin) oral solution, titrated up to the highest tolerated dose during the Titration period (specific dose titration schedule described in protocol; maximum daily dose amount recorded as 36 mg in product data).
Adaptive
True: study uses dose titration/escalation elements — participants are titrated up to the highest tolerated dose of LP352 during the Titration period (Visit 2–Visit 5); reverse titration described in taper for discontinuation. (No additional adaptive interim analysis/stopping rule detail available in the provided record.)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
73

Eligibility

Recruits 73 paediatric patients.

Vulnerable Population
The trial includes vulnerable populations (paediatric subjects; isVulnerablePopulationSelected = true). Consent procedures include written informed consent from the participant where capable, or from parent/legal guardian/ caregiver (Caregiver-ICF, Main-Parents_Leg_Guardian-ICF, LAR substudy ICF). Age-appropriate assent forms are provided (assent forms for 6–11 years and 12–17 years, picturebooks and assent materials for younger children). Subject information and consent/assent documents and caregiver/LAR forms are provided in multiple country/language versions (examples: Italian, Latvian, Russian, German, French, Spanish, Portuguese, Dutch, English) as indicated in the published ICF and assent documents.

Inclusion criteria

  • {"criterion_text":"-Participant is ≥2 to ≤65 years of age at the time of Screening"}
  • {"criterion_text":"-Diagnosis of Dravet Syndrome according to International League Against Epilepsy definition and must fulfill all of the following criteria: a. Onset of seizures age >1 and <20 months in an otherwise healthy infant. b. History of at least 1 of the following seizure type(s): i. Prolonged generalized tonic-clonic ii. Hemiclonic iii. Myoclonic iv. Tonic v. Atonic vi. Atypical absence vii. Focal awareness viii. Nonconvulsive status epilepticus"}
  • {"criterion_text":"-The following countable motor seizure types: a. Generalized tonic-clonic b. Tonic (bilateral) c. Clonic (bilateral) d. Atonic (bilateral) with truncal/leg involvement e. Focal motor (including hemiclonic) f. Focal to bilateral tonic-clonic"}
  • {"criterion_text":"-Demonstrated an average of at least 4 countable motor seizures (as per inclusion criterion 3) per month for the 3 months prior to Screening"}
  • {"criterion_text":"-Has been taking 1 to 4 ASMs at a stable dose for at least 4 weeks prior to Screening"}
  • {"criterion_text":"-The participant must be willing and able to provide written informed consent."}
  • {"criterion_text":"-The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study."}

Exclusion criteria

  • {"criterion_text":"-The participant has a history of infantile/epileptic spasms."}
  • {"criterion_text":"-The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening."}
  • {"criterion_text":"-The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing."}
  • {"criterion_text":"-The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures."}
  • {"criterion_text":"-The participant is receiving exclusionary medications, as described in the protocol."}
  • {"criterion_text":"-The participant has used any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC)"}
  • {"criterion_text":"-The participant has unstable, clinically significant neurologic (other than the disease being studied; e.g., recurrent strokes), psychiatric, cardiovascular (e.g., pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results."}
  • {"criterion_text":"-The participant is unwilling to comply with any of the study requirements or timelines."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Frequency percent change in countable motor seizures during Maintenance compared to Baseline","definition_or_measurement_approach":"Percent change in countable motor seizures during the Maintenance period compared with Baseline. Countable motor seizure types (per inclusion criterion 3) are: Generalized tonic-clonic; Tonic (bilateral); Clonic (bilateral); Atonic (bilateral) with truncal/leg involvement; Focal motor (including hemiclonic); Focal to bilateral tonic-clonic."}

Secondary endpoints

  • {"endpoint_text":"-Safety laboratory parameters","definition_or_measurement_approach":"Standard safety laboratory assessments as per protocol (laboratory parameters listed as secondary endpoint)."}
  • {"endpoint_text":"-Physical examination findings","definition_or_measurement_approach":"Routine physical examinations recorded during study visits."}
  • {"endpoint_text":"-Vital signs","definition_or_measurement_approach":"Standard vital signs measurements (e.g., blood pressure, heart rate, temperature) per protocol."}
  • {"endpoint_text":"-Growth parameters (height and weight)","definition_or_measurement_approach":"Measurement of participant height and weight at specified visits to assess growth parameters."}
  • {"endpoint_text":"-12-lead Electrocardiogram (ECGs)","definition_or_measurement_approach":"12-lead ECG assessments per schedule; ECG data collected and analyzed for cardiac safety."}
  • {"endpoint_text":"-Columbia-Suicide Severity Rating Scale (C-SSRS) responses","definition_or_measurement_approach":"C-SSRS questionnaire responses collected per protocol to assess suicidality."}
  • {"endpoint_text":"-Patient Health Questionnaire-9 (PHQ-9) total score and Question 9 score","definition_or_measurement_approach":"PHQ-9 instrument total score and item 9 score collected to monitor depressive symptoms and suicidal ideation."}
  • {"endpoint_text":"-50% responder rate (the percentage of participants with a ≥50% reduction in countable motor seizures) during Maintenance compared to Baseline","definition_or_measurement_approach":"Proportion of participants achieving ≥50% reduction in countable motor seizures during Maintenance versus Baseline."}
  • {"endpoint_text":"-Frequency percent change in countable motor seizures during Treatment compared to Baseline","definition_or_measurement_approach":"Percent change in countable motor seizures during the Treatment period compared with Baseline (treatment period defined in protocol)."}

Recruitment

Digital Remote Recruitment
True: digital/remote methods include study websites (DEEp-studies and country pages), online brochures and flyers, cookie/privacy policies for web recruitment, telephone pre-screening (Pre-ICF Telephone Data Consent), and eCOA/eDiary platforms (WCG Clinical; Medidata).
Planned Sample Size
73
Recruitment Window Months
12
Consent Approach
Written informed consent is required. Consent is obtained from participants able to provide written informed consent; for minors or participants lacking capacity, consent is obtained from parent/legal guardian or caregiver (Caregiver-ICF, Main-Parents/Legal Guardian ICF, LAR substudy ICF). Age-appropriate assent materials are provided (assent forms for 6–11 years and 12–17 years, picturebooks and assent materials for younger children, and substudy assent forms). Consent and assent documents are available in multiple country/language versions as published (examples include Italian, Latvian, Russian, German, French, Spanish, Portuguese, Dutch, English).

Methods

  • Study-specific websites and online content (DEEp-studies website and country-specific recruitment website content; multiple languages) — recruitment webpages and images documented in recruitment materials.
  • Brochures and patient flyers distributed as recruitment materials (country- and language-specific brochures and flyers listed for BE, DE, ES, FR, IT, LV, PT, NL, FI, DK).
  • Pre-screening telephone data consent procedures (Pre-ICF Telephone Data Consent documents present) indicating telephone pre-screening/contact method.
  • Patient-facing materials and study information sheets (country-specific ICF and study information documents) used for participant information and recruitment.
  • Patient recruitment support and website/promo items provided by third-party vendors (e.g., Elligo Health Research Inc. listed with responsibilities for patient recruitment and website/promo items).
  • Use of electronic diaries/eCOA and vendor-managed digital tools (WCG Clinical Inc., Medidata) to support data capture and remote engagement.

Geography

Total Number Of Sites
39
Total Number Of Participants
110

Italy

Earliest CTIS Part Ii Submission Date
14-04-2025
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
282
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Neuroscience and Medical Genetics Department
Principal Investigator Name
Renzo Guerrini
Principal Investigator Email
renzo.guerrini@meyer.it
Contact Person Name
Renzo Guerrini
Contact Person Email
renzo.guerrini@meyer.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Pediatric Neuropsychiatry
Principal Investigator Name
Domenica Immacolata Battaglia
Contact Person Name
Domenica Immacolata Battaglia
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
SC Neuropsichiatria Infantile
Principal Investigator Name
Valentina Valentina De Giorgis
Principal Investigator Email
valentina.degiorgis@mondino.it
Contact Person Name
Valentina Valentina De Giorgis
Contact Person Email
valentina.degiorgis@mondino.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Neuropsichiatria infantile
Principal Investigator Name
Francesca Darra
Principal Investigator Email
francesca.darra@univr.it
Contact Person Name
Francesca Darra
Contact Person Email
francesca.darra@univr.it
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
UOC Pediatric Neurology and Muscolar Diseases
Principal Investigator Name
Pasquale Striano
Principal Investigator Email
strianop@gmail.com
Contact Person Name
Pasquale Striano
Contact Person Email
strianop@gmail.com
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
UOC Neurologia dell'epilessia e disturbi del movimento
Principal Investigator Name
Nicola Specchio
Principal Investigator Email
nicola.specchio@opbg.net
Contact Person Name
Nicola Specchio
Contact Person Email
nicola.specchio@opbg.net

Latvia

Earliest CTIS Part Ii Submission Date
21-01-2025
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
364
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Bernu Kliniska Universitates Slimnica VSIA
Department Name
Children‘s Neurology and Neurosurgery Clinic
Principal Investigator Name
Jurgis Strautmanis
Principal Investigator Email
jurgis.strautmanis@gmail.com
Contact Person Name
Jurgis Strautmanis
Contact Person Email
jurgis.strautmanis@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
16-04-2025
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
279
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Kinderneurologie
Principal Investigator Name
An-Sofie Schoonjans
Principal Investigator Email
an-sofie.schoonjans@uza.be
Contact Person Name
An-Sofie Schoonjans
Contact Person Email
an-sofie.schoonjans@uza.be
Site Name
UZ Leuven
Department Name
Kinderneurologie
Principal Investigator Name
Lieven Lagae
Principal Investigator Email
lieven.lagae@uzleuven.be
Contact Person Name
Lieven Lagae
Contact Person Email
lieven.lagae@uzleuven.be

Germany

Earliest CTIS Part Ii Submission Date
11-04-2025
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
285
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Zentrum für Psychiatrie Südwürttemberg Epilepsy Centre Bodensee
Department Name
Department of Neurology and Epileptology
Principal Investigator Name
Christian Tilz
Principal Investigator Email
Christian.Tilz@ZfP-Zentrum.de
Contact Person Name
Christian Tilz
Contact Person Email
Christian.Tilz@ZfP-Zentrum.de
Site Name
Schoen Klinik Vogtareuth SE & Co. KG
Principal Investigator Name
Milka Pringsheim
Principal Investigator Email
MPringsheim@schoen-klinik.de
Contact Person Name
Milka Pringsheim
Contact Person Email
MPringsheim@schoen-klinik.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Kinder- und Jugendmedizin II Abteilung für Neuropädiatrie und Sozialpädiatrie
Principal Investigator Name
Hiltrud Muhle
Principal Investigator Email
hiltrud.muhle@uksh.de
Contact Person Name
Hiltrud Muhle
Contact Person Email
hiltrud.muhle@uksh.de
Site Name
Gesellschaft Fuer Epilepsieforschung
Department Name
Epilepsieambulanz
Principal Investigator Name
Christian Brandt
Principal Investigator Email
christian.brandt@mara.de
Contact Person Name
Christian Brandt
Contact Person Email
christian.brandt@mara.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Neuropädiatrie @ Sozialpädiatrisches Zentrum (SPZ)
Principal Investigator Name
Kerstin Alexandra Klotz
Contact Person Name
Kerstin Alexandra Klotz
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
ZNN – Epilepsy Center Rhine-Main
Principal Investigator Name
Adam Strzelczyk
Principal Investigator Email
strzelczyk@med.uni-frankfurt.de
Contact Person Name
Adam Strzelczyk

Portugal

Earliest CTIS Part Ii Submission Date
21-01-2025
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
364
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Child development Center Service - Hospital Pediátrico - ULS Coimbra
Principal Investigator Name
Cristina Pereira
Principal Investigator Email
cristina.d.pereira@gmail.com
Contact Person Name
Cristina Pereira
Contact Person Email
cristina.d.pereira@gmail.com
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Paediatrics Department
Principal Investigator Name
Sofia Quintas
Principal Investigator Email
sofiamendesquintas@gmail.com
Contact Person Name
Sofia Quintas
Contact Person Email
sofiamendesquintas@gmail.com
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Paediatrics - NeuroPediatric Unit
Principal Investigator Name
Cristina Garrido
Principal Investigator Email
cristinagarrido@ulssa.min-saude.pt
Contact Person Name
Cristina Garrido

Spain

Earliest CTIS Part Ii Submission Date
14-04-2025
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
290
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Hospital Universitario De Navarra
Department Name
Pediatrics
Principal Investigator Name
Sergio Aguilera Albesa
Principal Investigator Email
saguilea@navarra.es
Contact Person Name
Sergio Aguilera Albesa
Contact Person Email
saguilea@navarra.es
Site Name
Hospital La Milagrosa S.A.
Department Name
Neurology
Principal Investigator Name
Maria del Mar Carreño Martinez
Principal Investigator Email
maria.carreno@ext.vithas.es
Contact Person Name
Maria del Mar Carreño Martinez
Contact Person Email
maria.carreno@ext.vithas.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Principal Investigator Name
Manuel Toledo Argany
Principal Investigator Email
manuel.toledo@vallhebron.cat
Contact Person Name
Manuel Toledo Argany
Contact Person Email
manuel.toledo@vallhebron.cat
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Neurology
Principal Investigator Name
Maria del Carmen Fons Estupiña
Principal Investigator Email
carmen.fons@sjd.es
Contact Person Name
Maria del Carmen Fons Estupiña
Contact Person Email
carmen.fons@sjd.es
Site Name
Hospital Ruber Internacional
Department Name
Neurology
Principal Investigator Name
Antonio Gil-Nagel Rein
Principal Investigator Email
gilnagel.ensayos@neurologiaclinica.es
Contact Person Name
Antonio Gil-Nagel Rein
Site Name
Hospital Vithas Parque San Antonio
Department Name
Neurology
Principal Investigator Name
Pablo Cabezudo Garcia
Principal Investigator Email
pablocabezudogcp@gmail.com
Contact Person Name
Pablo Cabezudo Garcia
Contact Person Email
pablocabezudogcp@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurology
Principal Investigator Name
Pedro J. Serrano Castro
Principal Investigator Email
p.serrano.eecc@gmail.com
Contact Person Name
Pedro J. Serrano Castro
Contact Person Email
p.serrano.eecc@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Principal Investigator Name
Alba Sierra Marcos
Principal Investigator Email
asierram@santpau.cat
Contact Person Name
Alba Sierra Marcos
Contact Person Email
asierram@santpau.cat

France

Earliest CTIS Part Ii Submission Date
15-04-2025
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
303
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Neuropédiatrie
Principal Investigator Name
Anne DE SAINT MARTIN
Principal Investigator Email
Anne.desaintmartin@chru-strasbourg.fr
Contact Person Name
Anne DE SAINT MARTIN
Site Name
Hospices Civils De Lyon
Department Name
Neurologie fonctionnelle et épileptologie
Principal Investigator Name
Sylvain RHEIMS
Principal Investigator Email
sylvain.rheims@chu-lyon.fr
Contact Person Name
Sylvain RHEIMS
Contact Person Email
sylvain.rheims@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Neuropédiatrie
Principal Investigator Name
Sylvie NGUYEN THE TICH
Principal Investigator Email
sylvie.nguyenthetich@chru-lille.fr
Contact Person Name
Sylvie NGUYEN THE TICH
Site Name
Hopital Des Enfants
Department Name
Neurologie, Infectiologie Pédiatrique
Principal Investigator Name
Caroline HACHON LE CAMUS
Principal Investigator Email
hachonlecamus.c@chu-toulouse.fr
Contact Person Name
Caroline HACHON LE CAMUS
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurologie pédiatrique
Principal Investigator Name
Rima EL NABBOUT
Principal Investigator Email
Rima.Nabbout@aphp.fr
Contact Person Name
Rima EL NABBOUT
Contact Person Email
Rima.Nabbout@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Pédiatrie
Principal Investigator Name
Silvia NAPURI PEIRANO
Principal Investigator Email
silvia.napuri@chu-rennes.fr
Contact Person Name
Silvia NAPURI PEIRANO
Contact Person Email
silvia.napuri@chu-rennes.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Neurologie Pédiatrique et Epileptologie Pédiatrique
Principal Investigator Name
Mathieu MILH
Principal Investigator Email
mathieu.milh@ap-hm.fr
Contact Person Name
Mathieu MILH
Contact Person Email
mathieu.milh@ap-hm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurologie Pédiatrique
Principal Investigator Name
Stéphane AUVIN
Principal Investigator Email
stephane.auvin@aphp.fr
Contact Person Name
Stéphane AUVIN
Contact Person Email
stephane.auvin@aphp.fr

Denmark

Earliest CTIS Part Ii Submission Date
07-05-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
4
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Filadelfia
Department Name
Neuropaediatric Department
Principal Investigator Name
Kern Olofsson
Principal Investigator Email
kol@filadelfia.dk
Contact Person Name
Kern Olofsson
Contact Person Email
kol@filadelfia.dk
Site Name
Region Midtjylland
Department Name
Department of Neurology, Neurological Research Unit
Principal Investigator Name
Jakob Christensen
Principal Investigator Email
jakob@farm.au.dk
Contact Person Name
Jakob Christensen
Contact Person Email
jakob@farm.au.dk

Finland

Earliest CTIS Part Ii Submission Date
20-04-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
22
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Pohjois-Savon hyvinvointialue
Department Name
Epilepsy Center
Principal Investigator Name
Reetta Kälviäinen
Principal Investigator Email
reetta.kalviainen@pshyvinvointialue.fi
Contact Person Name
Reetta Kälviäinen
Site Name
HUS-yhtymae
Department Name
General Child Neurology Clinic and Children and Adolescents, Pediatric Clinical Trial Unit
Principal Investigator Name
Eeva-Liisa Metsähonkala
Principal Investigator Email
eeva-liisa.metsahonkala@hus.fi
Contact Person Name
Eeva-Liisa Metsähonkala
Contact Person Email
eeva-liisa.metsahonkala@hus.fi

Netherlands

Earliest CTIS Part Ii Submission Date
15-04-2025
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
343
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Epilepsie Instellingen Nederland Stichting
Department Name
Epilepsy
Principal Investigator Name
Aysun Altinbas
Principal Investigator Email
polikliniek.heemstede@sein.nl
Contact Person Name
Aysun Altinbas
Contact Person Email
polikliniek.heemstede@sein.nl

Sponsor

Primary sponsor

Full Name
Longboard Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
Multiple sponsor duties (codes: 1,11,12,13,14,2,4,5,6,7,8) as listed in third-party duties
Name
PPD International Holdings LLC
Responsibilities
Sponsor duties (code: 4) as listed in third-party duties
Name
WCG Clinical Inc.
Responsibilities
eCoa/eDiary; other sponsor duties (code: 7)
Name
Endpoint Clinical Inc.
Responsibilities
Sponsor duties (code: 3)

Third parties

  • {"country":"Germany","full_name":"Centogene GmbH","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1,11,12,13,14,2,4,5,6,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel and reimbursements, stipends","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"eCoa/eDiary; sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG, cardiac services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Longterm sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Marken LLP","duties_or_roles":"Courier, DTP/DFP Shipment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"URL; sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Elligo Health Research Inc.","duties_or_roles":"Patient recruitment and website, promo items","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Bexicaserin
Active Substance
BEXICASERIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL, NASOGASTRIC TUBE OR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE USE
Route
ORAL or via G-tube/PEG
Authorisation Status
prodAuthStatus: 1
Maximum Dose
36 mg (maxDailyDoseAmount)
Dose Escalation Increase
Participants are titrated up to highest tolerated dose during Titration period (specific initial and subsequent dose levels not provided in CTIS record)
Investigational Product Name
LP352 (bexicaserin) Placebo Oral Solution
Modality
Other

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