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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05729373
Other study ID # SEP361-226
Secondary ID 2022-502077-42-0
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date March 8, 2023
Est. completion date February 8, 2025

Study information

Verified date March 2024
Source Sumitomo Pharma America, Inc.
Contact CNS Medical Director
Phone 1-866-503-6351
Email ClinicalTrialDisclosure@sunovion.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.


Description:

This is a multicenter, randomized, double-blind, parallel-group, flexible dose, outpatient study evaluating the efficacy and safety of SEP-363856 flexibly dosed (50 - 75 mg/day) versus placebo over an 8-week Treatment Period in subjects with GAD. This study is projected to randomize approximately 434 subjects to 2 treatment groups (SEP-363856 [50 - 75 mg/day] or placebo) in a 1:1 ratio. Approximately 30 additional subjects (N = 15 per treatment group) are projected to enroll in the Japan Cohort. Treatment assignment will be stratified by country. Study drug will be taken at approximately the same time each evening at bedtime .


Recruitment information / eligibility

Status Recruiting
Enrollment 434
Est. completion date February 8, 2025
Est. primary completion date February 8, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: (list is not all inclusive) - Male or female subject between 18 to 65 years of age. - Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder. - Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions. Exclusion Criteria: (list is not all inclusive) - Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder that was the primary focus of treatment within 12 months before Screening. - Subjects who report an inadequate response to more than 3 antidepressant treatments - Subject is at significant risk of harming self or others based on Investigator's judgment. - Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study. - Female subject who is pregnant, lactating, or plans to get pregnant during the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SEP-363856
once daily tablet
Placebo
once daily tablet

Locations

Country Name City State
Bulgaria Medical Center Mentalcare OOD 107 Aleksandar Stamboliyski Blvd., Plovdiv
Bulgaria Medical Center Sveti Naum EOOD 1 Dr. Lyuben Russev Str. Sofia
Bulgaria Medical Center Hera EOOD 20 Klisura Str., Fl. 2 Sofia
Bulgaria Medical Center Spectar - Plovdiv EOOD 107 Makedonia Str., Ground Floor Plovdiv
Bulgaria Medical Center Intermedica OOD 62 Nishava Str., Sofia
Bulgaria DCC St. Vrach and St. St. Kuzma and Damian OOD 17, Dimitar Manov Str., Sofia
Bulgaria Medical Center Medconsult Pleven OOD Pleven
Bulgaria DCC Mladost-M Varna OOD 15 Republika Blvd., MC Mladost, 3rd Floor Varna
Bulgaria DCC Mladost-M Varna OOD 15 Republika Blvd., MC Mladost, 3rd Floor Varna
Bulgaria Mental Health Center - Sofia EOOD 309 Slivnitsa Blvd. Sofia
Estonia Tartu University Hospital Raja 31 Tartu
Estonia Marienthali Kliinik Kotka 12 Tallinn
Finland Lääkärikeskus Aava Kamppi Annankatu 32 Helsinki
Finland Savon Psykiatripalvelu Oy Asemakatu 46 B 23 Kuopio
Finland Mederon Ltd. Helsinki
Finland Oulu Mentalcare Oy Isokatu 8 B 8 Oulu
Finland Satakunnan Psykitaripalvelu Oy at Mehilainen Tampere Finlayson Ltainenkatu Tampere
Japan Uematsu Mental Clinic Chikugo-shi Fukuoka-Ken
Japan Hiro Mental Clinic Fukuoka-shi Fukuoka-Ken
Japan Mental Clinic Sakurazaka Fukuoka-shi Fukuoka-Ken
Japan Shinseikai Kaku Mental Clinic Fukuoka-Shi Fukuoka-Ken
Japan Kokura Mental Clinic Kitakyushu-shi Fukuoka-Ken
Japan Hayakawa Clinic Kure-shi Hiroshima-Ken
Japan Hirota Clinic Kurume-shi Fukuoka-Ken
Japan Senzoku Psychosomatic Clinic Meguro-ku Tokyo-To
Japan Akari Clinic Naha-shi Okinawa-Ken
Japan Higashi-Sapporo Mental Clinic Sapporo-shi Hokkaido
Japan Shimode Mental Clinic Sapporo-shi Hokkaido
Japan Sangenjaya Nakamura Mental Clinic Setagaya-ku Tokyo-To
Japan Sangenjaya Neurology- Psychosomatic Clinic Setagaya-ku Tokyo-To
Japan Barclay Imuro Mental Clinic Urasoe-shi Okinawa-Ken
Slovakia Bona Medic Bernolákova 24 953 01 Zlaté Moravce
Slovakia MENTUM, s.r.o. Bratislava Ruzinovska
Slovakia PsychoLine s.r.o. Dobsinskeho 4861 Rimavska Sobota
Slovakia EPAMED s.r.o. Hlavna 68 Kosice
Slovakia Crystal Comfort s.r.o. M. R. Stefanika 2427 Vranov Nad Toplou
Spain Hospital Universitario Fundacion Alcorcón Alcorcón Madrid
Spain Hospital de Antequera Avda. Poeta Muñoz Rojas, S/n Antequera Málaga
Spain Institucion Hospitalaria Hestia Palau Barcelona C/ De Saint Antoni Maria Claret, 135
Spain Hospital Valle del Nalon Langreo Asturias
Spain Hospital Universitario Infanta Leonor, Dept of Psychiatry C/Gran Vía del Madrid
Sweden Pharmasite Föreningsgatan 26, Malmö,
Sweden Sahlgrenska University Hospita/ Affektiva l, FoU-avdelningen Plan 3, Psykiatri Gothenburgh
Sweden ProbarE i Lund Lilla Fiskaregatan 10 Lund
Sweden ProbarE Vegagatan 8 Stockholm
United States Lehigh Center for Clinical Research, LLC Allentown Pennsylvania
United States NeuroTrials Research, Inc. Atlanta Georgia
United States Donald J. Garcia Jr., MD, PA Austin Texas
United States Boston Clinical Trials Boston Massachusetts
United States Neurobehavioral Research, Inc. Cedarhurst New York
United States Center for Emotional Fitness Cherry Hill New Jersey
United States Uptown Research Institute, LLC Chicago Illinois
United States FutureSearch Trials of Dallas, LP Dallas Texas
United States UAB Huntsville Regional Medical Campus Huntsville Alabama
United States The Medical Research Network, L.L.C New York New York
United States Dr. Shishuka Malhotra North Canton Ohio
United States Excell Research, Inc. Oceanside California
United States Sooner Clinical Research Oklahoma City Oklahoma
United States Olympian Clinical Research Tampa Florida
United States Viking Pharmaceutical Trials Inc. dba Viking Clinical Research Temecula California
United States CenExel Collaborative Neuroscience Research Torrance California

Sponsors (1)

Lead Sponsor Collaborator
Sumitomo Pharma America, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Estonia,  Finland,  Japan,  Slovakia,  Spain,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint The HAM-A scale consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point (0-4) scale, with higher scores indicating greater severity. Week 8
Secondary Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity. Week 8
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