CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 418 enrolled
Drug / intervention
Lisdexamfetamine dimesylate +1 moredrug
Likely dose
Lisdexamfetamine dimesylate 70mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02009163
NCT02009163Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Shire·interventional·Posted Dec 11, 2013·Updated Jun 14, 2021

In Brief

A Phase 3 clinical trial evaluating Lisdexamfetamine dimesylate and Placebo for Binge Eating Disorder. Completed, enrolled 418 participants across 53 sites in 5 countries.

Detailed Summary

To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBinge Eating Disorder
CountriesCanada, Germany, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 11, 2013
Enrollment StartJan 27, 2014
Primary CompletionApr 8, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.6 years ago

Interventions

Lisdexamfetamine dimesylatedrug

SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods)

Placeboother

Placebo capsule once per day (double-blind period)