NCT04602936

Solriamfetol in Binge Eating Disorder

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Lindner Center of HOPE · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this project is to evaluate the efficacy and tolerability of the novel dopamine and norepinephrine reuptake inhibitor (DNRI) solriamfetol in the treatment of binge eating disorder (BED).

Detailed description

This is a 1-site, randomized, parallel group, double-blind, placebo-controlled, flexible-dose study in which solriamfetol 37.5-150 mg/day will be administered for 12 weeks to 64 outpatient adults with BED by DSM-5 criteria. The study will have 3 phases: a 1-2 week Screening phase to evaluate participant eligibility; a 12-week blinded Treatment phase during which participants will receive solriamfetol or matching placebo; and a 1-week Treatment Discontinuation phase. During the Treatment phase, participants will be evaluated weekly for the first 4 weeks and then biweekly for the next 8 weeks. Solriamfetol will be started at 37.5 mg/day. After 1 week, study drug will be increased to 75 mg/day. If a participant continues to have BED symptoms, study drug may be increased to a maximum of 150 mg/d by Treatment week 6; after that, study drug dose will be held constant. Efficacy will be assessed by measuring the weekly frequency of binge-eating episode days with patient take-home diaries. Regular monitoring of vital signs, laboratory tests, electrocardiograms (ECGs), adverse events, and suicidality will assess safety

Conditions

• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	Solriamfetol	Solriamfetol is a novel DNRI (novel dopamine and norepinephrine reuptake inhibitor) that has recently received regulatory approval for the treatment of excessive daytime sleepiness in individuals with narcolepsy or obstructive sleep apnea.
DRUG	Placebo	A placebo is a substance or treatment which is designed to have no therapeutic value (an inactive compound, i.e. inert, often called a "sugar pill").

Timeline

• Start date: 2021-06-15
• Primary completion: 2024-08-30
• Completion: 2024-12-30
• First posted: 2020-10-26
• Last updated: 2023-03-08

Locations

1 site across 1 country: United States