Health TrialsbyHealthPanel

Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

ConditionBinge-Eating Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAxsome Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary diagnosis of BED according to DSM-5 criteria.

Provides written informed consent to participate in the study before the conduct of any study procedures.

Male or female, aged 18 to 55 inclusive.

Disqualifiers

Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.

Unable to comply with study procedures.

Medically inappropriate for study participation in the opinion of the investigator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Solriamfetol 150 mg

    Drug

    Solriamfetol tablets, taken once daily

  • Solriamfetol 300 mg

    Drug

    Solriamfetol tablets, taken once daily

  • Placebo

    Drug

    Placebo tablets, taken once daily

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: Solriamfetol 150 mgExperimental treatment 1 intervention
Group B: Solriamfetol 300 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline to Week 12 in number of binge eating episodes

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Axsome Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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