An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
Purpose
This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.
Condition
- Post Traumatic Stress Disorder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Meets the DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months. - Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy. - Proficient in communication (verbal and reading) to complete interviews and written questionnaires. - Free from any other clinically significant illness or disease.
Exclusion Criteria
- Primary diagnosis of any other DSM-5 disorder. - Body mass index (BMI) <18 kg/m2 or ≥40 kg/m2. - Unable to refrain from nicotine use for at least 8 hours. - Use of prohibited concomitant medications or therapies. - Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Sponsor
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TSND-201, Dose Level 1 |
|
|
|
Experimental TSND-201, Dose Level 2 |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Preferred Research Partners
Little Rock, Arkansas 72211
Little Rock, Arkansas 72211
Contact:
Study Coordinator
501-553-9987
Study Coordinator
501-553-9987
CalNeuro Research Group
Los Angeles, California 90025
Los Angeles, California 90025
Catalina Research Institute
Montclair, California 91763
Montclair, California 91763
Inland Psychiatric Medical Group
San Juan Capistrano, California 92675
San Juan Capistrano, California 92675
Starlight Clinical Research
Evergreen, Colorado 80439
Evergreen, Colorado 80439
CNS Healthcare
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Contact:
Study Coordinator
904-281-5757
Study Coordinator
904-281-5757
Accel Clinical Research
Maitland, Florida 32751
Maitland, Florida 32751
Contact:
Ashley Thompson, Clinical Operations Manager
407-644-1165
ashley.thompson@accelclinical.com
Ashley Thompson, Clinical Operations Manager
407-644-1165
ashley.thompson@accelclinical.com
Uptown Research Institute
Chicago, Illinois 60640
Chicago, Illinois 60640
Vitalix Clinical
Worcester, Massachusetts 01608
Worcester, Massachusetts 01608
Midwest Research GRoup
Saint Charles, Missouri 63304
Saint Charles, Missouri 63304
Global Medical Institutes
Princeton, New Jersey 08540
Princeton, New Jersey 08540
Bio Behavioral Health
Toms River, New Jersey 08755
Toms River, New Jersey 08755
Insight Clinical Trials
Independence, Ohio 44131
Independence, Ohio 44131
Contact:
Elisa Poggi
216-526-1843
Elisa Poggi
216-526-1843
Suburban Research Associates
West Chester, Pennsylvania 19380
West Chester, Pennsylvania 19380
Austin Clinical Trial Partners
Austin, Texas 78737
Austin, Texas 78737
Contact:
Kara Chilek
512-521-0595
Kara Chilek
512-521-0595
Haracec Clinical Research
El Paso, Texas 79902
El Paso, Texas 79902
Inner Space Research
Orem, Utah 84058
Orem, Utah 84058
More Details
- Status
- Recruiting
- Sponsor
- Transcend Therapeutics