Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413433
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-09
Brief Title:
Elucidating TAAR-1 Dopamine and Norepinephrine in Binge Eating Disorder Using Solriamfetol
Sponsor:
Axsome Therapeutics Inc
Organization:
Axsome Therapeutics Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder BED
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENGAGE
Brief Summary:
ENGAGE Elucidating TAAR-1 Dopamine and Norepinephrine in Binge Eating Disorder Using Solriamfetol is a Phase 3 randomized double-blind placebo-controlled multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder BED in adults
Detailed Description:
Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition DSM-5 criteria Subjects will be randomized in a 111 ratio to receive solriamfetol 150 or 300 mg or placebo once daily for 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None