A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

A Phase 2/3, Randomized, Double-blind, Parallel Group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder

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
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

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