Solriamfetol in Binge Eating Disorder

Part of paid clinical trials in Mason, Ohio.

Sponsor
Lindner Center of HOPE
Study ID
NCT04602936
Phase
PHASE4
Status
Unknown

Conditions

  • Binge Eating Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Solriamfetol — DRUG
    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.
  • Placebo — DRUG
    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").

Study Details

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).

Key Dates

Start date
Jun 15, 2021
Status verified
Mar 2023
Primary completion
Aug 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Solriamfetol
    All medication will be 37.5 mg encapsulated soriamfetol tablets or matching encapsulated placebo tablets supplied in numbered containers for dispensing to patients. The minimum dose of solriamfetol during the trial will be 37.5 mg/day; the maximum dose will be 150 mg/day. At the Baseline Visit (Visit 0), participants will be instructed to take one capsule of solriamfetol 37.5 mg or matching placebo in the morning for the first 7 days. Thereafter, at Visit 1, solriamfetol or placebo will be increased to 75 mg/day, if tolerated. Beginning on day 15 (Visit 2), solriamfetol or placebo will be increased to 150 mg/day, if tolerated. Study medication dosage may be decreased, or a scheduled increase may not be made, because of side effects. Study medication will be administered as a single daily dose in the morning.
  • Placebo Comparator: Placebo
    Placebo (i.e., inactive compound for comparison)

Primary Outcome Measure

The primary efficacy variable is binge-eating day frequency as assessed by the take-home patient diary. [ Time Frame: Days 1-84 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lindner Center of HOPEMasonOhio45040
Anna Guerdjikova, phD
513-536-0700

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Lindner Center of HOPE· Mason, OH

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