Clinical trial • Phase III • Neurology
BEXICASERIN HYDROCHLORIDE for Developmental and Epileptic Encephalopathies
Phase III trial of BEXICASERIN HYDROCHLORIDE for Developmental and Epileptic Encephalopathies. open-label. 135 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Developmental and Epileptic Encephalopathies
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 04-03-2025
- First CTIS Authorization Date
- 17-06-2025
Trial design
open-label Phase III trial across 40 sites in Belgium, France, Netherlands and others.
- Open Label
- Yes
- Target Sample Size
- 135
Eligibility
Recruits 135 paediatric patients.
- Vulnerable Population
- Study includes children and other vulnerable participants (isVulnerablePopulationSelected = true). Consent approach: participants must be willing and able to provide written informed consent; where the participant is unable to provide consent, an appropriate legal representative must provide informed consent and the participant must assent (per local regulations) before participation. Study materials include age- and role-specific ICFs and assent forms (adult ICFs, caregiver ICFs, parent/LAR ICFs, pediatric assent for multiple age bands, picture books for young children, and pregnancy-specific materials) in multiple languages as provided per country.
Inclusion criteria
- {"criterion_text":"- 1. The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration."}
- {"criterion_text":"- 2. Diagnosis of DEE that includes DS, LGS, or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302)."}
- {"criterion_text":"- 3. Has at least one reliable and consistent parent, legal guardian, or caregiver during the study."}
- {"criterion_text":"- 4. The participant must be willing and able to provide written informed consent; in instances where the participant is unable to provide consent, an appropriate legal representative must provide informed consent and the participant will need to assent (as per local regulations) before participation in the study."}
- {"criterion_text":"- 5. 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":"- 1. Using exclusionary medications defined in protocol LP352-303"}
- {"criterion_text":"- 2. Current use of any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or containing ≥50% THC."}
- {"criterion_text":"- 3. Unstable, clinically significant neurologic (other than the disease being studied; eg, recurrent strokes), psychiatric, cardiovascular (eg, 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":"- 4. Is unable or unwilling to comply with any of the study requirements or timelines."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Incidence and severity of TEAEs, including SAEs and AEs leading to discontinuation","definition_or_measurement_approach":"Collection and reporting of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation through safety monitoring and investigator reporting."}
- {"endpoint_text":"- 2. Changes in safety laboratory parameters","definition_or_measurement_approach":"Laboratory safety tests (clinical chemistry, hematology, etc.) assessed over time to detect changes from baseline."}
- {"endpoint_text":"- 3. Physical examination findings","definition_or_measurement_approach":"Periodic physical examinations with findings recorded and compared over treatment."}
- {"endpoint_text":"- 4. Vital signs","definition_or_measurement_approach":"Measurement of vital signs (e.g., blood pressure, heart rate, respiratory rate, temperature) at scheduled visits."}
- {"endpoint_text":"- 5. ECGs, and growth parameters (height and weight)","definition_or_measurement_approach":"Electrocardiograms performed per schedule; measurement of height and weight to assess growth parameters."}
- {"endpoint_text":"- 6. Changes in suicidality or depression as rated by C-SSRS and PHQ-9 responses","definition_or_measurement_approach":"Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire-9 (PHQ-9) questionnaires."}
- {"endpoint_text":"- 7. Changes in puberty development as rated by Tanner Staging","definition_or_measurement_approach":"Pubertal development assessed using Tanner staging at scheduled assessments."}
Secondary endpoints
- {"endpoint_text":"- 1. Frequency percent change in countable motor seizures during Treatment (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary","definition_or_measurement_approach":"Percent change in frequency of countable motor seizures using 28-day averages, assessed from participant/caregiver seizure eDiary (seizure eDiary/eDiaries)."}
- {"endpoint_text":"- 2. 50% responder rate (the percentage of participants with a ≥50% reduction in countable motor seizures) during Treatment (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary","definition_or_measurement_approach":"Proportion of participants achieving ≥50% reduction in countable motor seizures (28-day averages), assessed via seizure eDiary."}
- {"endpoint_text":"- 3. Frequency percent change in countable motor seizures during Maintenance (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary","definition_or_measurement_approach":"Percent change in seizure frequency during maintenance period (28-day averages) versus baseline, assessed via seizure eDiary."}
- {"endpoint_text":"- 4. 50% responder rate (the percentage of participants with a ≥50% reduction in countable motor seizures) during Maintenance (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary","definition_or_measurement_approach":"Proportion of participants with ≥50% reduction in countable motor seizures during maintenance (28-day averages) compared to baseline, assessed via seizure eDiary."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 135
- Recruitment Window Months
- 42
- Consent Approach
- Written informed consent required from the participant if able; where the participant is unable to provide consent, an appropriate legal representative (LAR) must provide informed consent and the participant must assent according to local regulations. Study documentation includes adult ICFs, caregiver ICFs, parent/LAR ICFs, pediatric assent forms for multiple age bands (e.g., 5-11, 6-11, 12-17), picture books for young children, pregnancy-specific ICFs/assent, and Study Information Sheets. Documents are provided in multiple languages across countries (English, Dutch, French, Spanish, Italian, Portuguese, German, Latvian, Russian and others as listed per-country documents).
Methods
- Patient recruitment via third-party vendor Elligo Health Research Inc.: "Patient recruitment and website, promo items" (vendor listed in thirdParties).
- eCOA/eDiary support via WCG Clinical Inc.: duty listed as "eCoa/eDiary".
- Patient travel support and reimbursements via Scout Clinical: "Patient travel and reimbursements, stipends".
- Courier and shipment logistics via Marken LLP: "Courier, DTP/DFP Shipment".
- ECG and cardiac services via Eresearchtechnology Inc.: "ECG, cardiac services".
- Study platform/URL support via Medidata Solutions Inc.: "URL" and other site/platform services.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 181
Belgium
- Earliest CTIS Part Ii Submission Date
- 19-03-2025
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 419
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- UZ Leuven
- Department Name
- Paediatric Neurology
- Principal Investigator Name
- Lieven Lagae
- Principal Investigator Email
- Lieven.lagae@uzleuven.be
- Contact Person Name
- Lieven Lagae
- Contact Person Email
- Lieven.lagae@uzleuven.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Pediatrics/ Pediatrics Neurology
- 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
France
- Earliest CTIS Part Ii Submission Date
- 03-06-2025
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 343
- Number Of Sites
- 8
- Number Of Participants
- 32
Sites
- 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 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
- Contact Person Email
- sylvie.nguyenthetich@chru-lille.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
- 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
- Contact Person Email
- hachonlecamus.c@chu-toulouse.fr
- 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
- Assistance Publique Hopitaux De Paris (48 Boulevard Serurier)
- 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
- Site Name
- Assistance Publique Hopitaux De Paris (149 Rue De Sevres)
- Department Name
- Neurologie pédiatrique
- Principal Investigator Name
- Rima EL NABBOUT-TARANTINO
- Principal Investigator Email
- Rima.Nabbout@aphp.fr
- Contact Person Name
- Rima EL NABBOUT-TARANTINO
- Contact Person Email
- Rima.Nabbout@aphp.fr
- 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
- Contact Person Email
- Anne.desaintmartin@chru-strasbourg.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 02-06-2025
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 344
- Number Of Sites
- 2
- Number Of Participants
- 18
Sites
- Site Name
- Wilhelmina Childrens Hospital
- Department Name
- Pediatric Neurology
- Principal Investigator Name
- Floor Jansen
- Principal Investigator Email
- f.e.jansen@umcutrecht.nl
- Contact Person Name
- Floor Jansen
- Contact Person Email
- f.e.jansen@umcutrecht.nl
- Site Name
- Epilepsie Instellingen Nederland Stichting
- Department Name
- Epilepsy
- Principal Investigator Name
- Zwany Metting
- Principal Investigator Email
- trial@sein.nl
- Contact Person Name
- Zwany Metting
- Contact Person Email
- trial@sein.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 30-05-2025
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 348
- Number Of Sites
- 10
- Number Of Participants
- 46
Sites
- Site Name
- Hospital La Milagrosa S.A.
- Department Name
- Epilepsy
- Principal Investigator Name
- Ana Laura Fernández Perrone
- Principal Investigator Email
- alfdezperrone@gmail.com
- Contact Person Name
- Ana Laura Fernández Perrone
- Contact Person Email
- alfdezperrone@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology Department
- 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 Universitario Regional De Malaga
- Department Name
- Neurology Department
- Principal Investigator Name
- Pedro Serrano Castro
- Principal Investigator Email
- p.serrano.eecc@gmail.com
- Contact Person Name
- Pedro Serrano Castro
- Contact Person Email
- p.serrano.eecc@gmail.com
- Site Name
- Hospital Vithas Parque San Antonio
- Department Name
- Neurology Department
- 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 Ruber Internacional
- Department Name
- Neurology Department
- Principal Investigator Name
- Antonio Gil-Nagel
- Principal Investigator Email
- gilnagel.ensayos@neurologiaclinica.es
- Contact Person Name
- Antonio Gil-Nagel
- Contact Person Email
- gilnagel.ensayos@neurologiaclinica.es
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- Neurology Department
- 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 Universitario Y Politecnico La Fe
- Department Name
- Neurology Department
- Principal Investigator Name
- Vicente Villanueva
- Principal Investigator Email
- vevillanuevah@yahoo.es
- Contact Person Name
- Vicente Villanueva
- Contact Person Email
- vevillanuevah@yahoo.es
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Neurology Department
- Principal Investigator Name
- Victor Soto Insuga
- Principal Investigator Email
- vsoto@salud.madrid.org
- Contact Person Name
- Victor Soto Insuga
- Contact Person Email
- vsoto@salud.madrid.org
- Site Name
- Hospital Universitario De Navarra
- Department Name
- Neurology Department
- 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 De La Santa Creu I Sant Pau
- Department Name
- Neurology Department
- Principal Investigator Name
- Alba Sierra Marcos
- Principal Investigator Email
- asierram@santpau.cat
- Contact Person Name
- Alba Sierra Marcos
- Contact Person Email
- asierram@santpau.cat
Germany
- Earliest CTIS Part Ii Submission Date
- 03-06-2025
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 343
- Number Of Sites
- 7
- Number Of Participants
- 31
Sites
- 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
- Contact Person Email
- strzelczyk@med.uni-frankfurt.de
- Site Name
- Gesellschaft Fuer Epilepsieforschung
- Department Name
- Krankenhaus Mara
- 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
- 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
- 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
- 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
- Epilepsiezentrum Kleinwachau gGmbH
- Department Name
- Fachklinik für Neurologie
- Principal Investigator Name
- Thomas Mayer
- Principal Investigator Email
- t.mayer@kleinwachau.de
- Contact Person Name
- Thomas Mayer
- Contact Person Email
- t.mayer@kleinwachau.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Neuropädiatrie und Sozialpädiatrisches Zentrum (SPZ)
- Principal Investigator Name
- Kerstin Alexandra Klotz
- Principal Investigator Email
- studie-kinderneurologie@ukbonn.de
- Contact Person Name
- Kerstin Alexandra Klotz
- Contact Person Email
- studie-kinderneurologie@ukbonn.de
Italy
- Earliest CTIS Part Ii Submission Date
- 02-06-2025
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 345
- Number Of Sites
- 7
- Number Of Participants
- 21
Sites
- Site Name
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino
- Department Name
- SC Neuropsichiatria Infantile
- Principal Investigator Name
- Valentina De Giorgis
- Principal Investigator Email
- valentina.degiorgis@mondino.it
- Contact Person Name
- 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
- 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
- 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
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- U.O.C. Pediatric Neuropsychiatry
- Principal Investigator Name
- Domenica Immacolata Battaglia
- Principal Investigator Email
- domenicaimmacolata.battaglia@policlinicogemelli.it
- Contact Person Name
- Domenica Immacolata Battaglia
- Contact Person Email
- domenicaimmacolata.battaglia@policlinicogemelli.it
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- SC Neuropsichiatria Infantile 2, Epilettologia e Neurologia dello Sviluppo (NOS)
- Principal Investigator Name
- Francesca Ragona
- Principal Investigator Email
- francesca.ragona@istituto-besta.it
- Contact Person Name
- Francesca Ragona
- Contact Person Email
- francesca.ragona@istituto-besta.it
- Site Name
- IRCCS Istituto Giannina Gaslini
- Department Name
- UOC Pediatric Neurology and Muscular Diseases
- Principal Investigator Name
- Pasquale Striano
- Principal Investigator Email
- pasqualestriano@gaslini.org
- Contact Person Name
- Pasquale Striano
- Contact Person Email
- pasqualestriano@gaslini.org
Latvia
- Earliest CTIS Part Ii Submission Date
- 04-06-2025
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 343
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Bernu Kliniska Universitates Slimnica VSIA
- Department Name
- Epilepsy and Sleep Medicine Centre
- Principal Investigator Name
- Jurgis Strautmanis
- Principal Investigator Email
- jurgis.strautmanis@gmail.com
- Contact Person Name
- Jurgis Strautmanis
- Contact Person Email
- jurgis.strautmanis@gmail.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 30-05-2025
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 347
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- 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
- Contact Person Email
- cristinagarrido@ulssa.min-saude.pt
- 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
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
- codes: 1,11,12,13,14,2,4,5,6,7,8
- Name
- PPD International Holdings LLC
- Responsibilities
- code: 4
- Name
- Endpoint Clinical Inc.
- Responsibilities
- code: 3
- Name
- Marken LLP
- Responsibilities
- Courier, DTP/DFP Shipment
- Name
- WCG Clinical Inc.
- Responsibilities
- eCoa/eDiary
Third parties
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: 1,11,12,13,14,2,4,5,6,7,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"eCoa/eDiary; code: 7","organisation_type":"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"}
- {"country":"United States","full_name":"Marken LLP","duties_or_roles":"Courier, DTP/DFP Shipment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mms Holdings Inc.","duties_or_roles":"codes: 5,6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"URL; code: 7","organisation_type":"Non-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":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG, cardiac services","organisation_type":"Pharmaceutical company"}
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, nasogastric tube, or PEG tube
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 36 mg (max daily)
- Investigational Product Name
- LP352 (bexicaserin) Placebo Oral Solution
- Modality
- Other
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