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A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With Moderate to Severe Binge Eating Disorder

NCT03107026 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 491

Last updated 2020-07-13

Study results available
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Summary

A study to evaluate a drug (dasotraline) on the safety, effectiveness and how well the body tolerates it, in adults with moderate to severe binge eating disorder

Conditions

  • Binge Eating Disorder

Interventions

DRUG

dasotraline 4mg

dasotraline 4mg tablet once daily

DRUG

dasotraline 6mg

dasotraline 6mg tablet once daily

DRUG

Placebo

Placebo tablet once daily

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • CNS Medical Director · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2018-05-16
Completion
2018-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03107026 on ClinicalTrials.gov