Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A 12-week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults With Moderate to Sev

Brief 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

Detailed Summary:

This is a randomized, double-blind, parallel-group, multicenter, outpatient study evaluating the efficacy and safety of 2 doses of dasotraline (4 and 6 mg/day) versus placebo over a 12-week treatment period in adults with BED. This study is projected to randomize approximately 480 subjects to 3 treatment groups in a 1:1:1 ratio (4 mg/day dasotraline, 6 mg/day dasotraline, and placebo).

Subjects randomized to placebo will receive placebo for the duration of the treatment period.

Subjects randomized to 4 mg/day dasotraline will receive 4 mg/day for the duration of the treatment period.

Subjects randomized to 6 mg/day dasotraline will be dosed with 4 mg/day dasotraline for the first 2 weeks of the treatment period and will be increased to 6 mg/day at Week 2.

If, in the judgment of the Investigator, the subject does not tolerate the assigned dose, he or she will be discontinued from the study.

The study will consist of 3 periods: Screening (up to 3 weeks), 12-weeks of treatment, and a 3-week study drug withdrawal period. Subjects who complete the 12-week double-blind treatment period in this study may be eligible to enroll and continue treatment for an additional 12 months in an open-label extension study (Study SEP360-322). Subjects who do not enter the extension study will complete the study drug withdrawal period in this study.


Sponsor: Sunovion

Current Primary Outcome: Change from baseline in number of binge days [ Time Frame: 12 Weeks ]

Change from baseline in number of binge days (defined as days during which at least 1 binge episode occurs) per week at Week 12


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in Clinical Global Impression-Severity (CGI-S )score [ Time Frame: 12 Weeks ]
    Change from baseline in Clinical Global Impression-Severity (CGI-S )score at week 12
  • Percent of subjects with a 4-week cessation from binge eating [ Time Frame: up to 12 Weeks ]
    Percent of subjects with a 4-week cessation from binge eating (defined as a 100% reduction for at least 28 consecutive days in the number of binge eating episodes prior to Week 12/end of treatment [EOT])
  • Change from baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) total score [ Time Frame: 12 Weeks ]
    Change from baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) total score at week 12
  • Change from baseline in number of binge days per week at Weeks 1, 2, 3, 4, 6, 8, and 10 [ Time Frame: up to 10 Weeks ]
    Change from baseline in number of binge days per week at Weeks 1, 2, 3, 4, 6, 8, and 10
  • Change from baseline in number of binge episodes per week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 [ Time Frame: up to 12 Weeks ]
    Change from baseline in number of binge episodes per week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
  • Change from baseline in CGI-S score at Weeks 2, 4, 6, 8, and 10 [ Time Frame: up to 10 Weeks ]
    Change from baseline in CGI-S score at Weeks 2, 4, 6, 8, and 10
  • Change from baseline in Y-BOCS-BE total score at Weeks 2, 4, 6, 8, and 10 [ Time Frame: up to 10 Weeks ]
    Change from baseline in Y-BOCS-BE total score at Weeks 2, 4, 6, 8, and 10
  • Change from baseline in Y-BOCS-BE subscale scores (obsessions and compulsions) at Weeks 2, 4, 6, 8, 10, and 12 [ Time Frame: up to 12 weeks ]
    Change from baseline in Y-BOCS-BE subscale scores (obsessions and compulsions) at Weeks 2, 4, 6, 8, 10, and 12
  • Change from baseline in Sheehan Disability Scale (SDS) total score and subscale scores (school/work disability, social life disability, and family life disability) at Weeks 6 and 12 [ Time Frame: 6 Weeks and 12 Weeks ]
    Change from baseline in Sheehan Disability Scale (SDS) total score and subscale scores (school/work disability, social life disability, and family life disability) at Weeks 6 and 12
  • Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 12 [ Time Frame: 12 Weeks ]
    Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 12
  • Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12 [ Time Frame: 12 Weeks ]
    Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12
  • Proportion of binge eating responders who have ≥ 75% reduction in the number of binge eating episodes from Baseline at Week 12 [ Time Frame: 12 Weeks ]
    Proportion of binge eating responders who have ≥ 75% reduction in the number of binge eating episodes from Baseline at Week 12
  • Change from baseline in Eating Disorder Examination Questionnaire (EDE-Q) modified including EDE-Q7 global score and 3 subscale scores (dietary restraint, shape/weight overvaluation, and body dissatisfaction) at Week 12 [ Time Frame: 12 Weeks ]
    Change from baseline in Eating Disorder Examination Questionnaire (EDE-Q) modified including EDE-Q7 global score and 3 subscale scores (dietary restraint, shape/weight overvaluation, and body dissatisfaction) at Week 12
  • The incidence of overall Averse Events (AEs), serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations [ Time Frame: 12 Weeks ]
    The incidence of overall Averse Events (AEs), serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations
  • Clinical laboratory evaluations (serum chemistry, hematology, and urinalysis) [ Time Frame: 12 Weeks ]
    Clinical laboratory evaluations (serum chemistry, hematology, and urinalysis)
  • Clinical evaluations (vital signs including orthostatic effects) [ Time Frame: 12 Weeks ]
    • Blood pressure and pulse taken with subject in supine position after resting for >=5 minutes
    • Blood pressure and pulse taken again after subject has been standing for 2 to 4 minutes
  • Clinical evaluations (vital signs including 12-lead ECGs) [ Time Frame: 12 Weeks 

    Original Secondary Outcome: Same as current

    Information By: Sunovion

    Dates:
    Date Received: March 17, 2017
    Date Started: March 31, 2017
    Date Completion: September 30, 2018
    Last Updated: June 5, 2017
    Last Verified: June 2017