CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 390 enrolled
Drug / intervention
SPD489 (Lisdexamfetamine dimesylate) +1 moredrug
Likely dose
SPD489 (Lisdexamfetamine dimesylate) 70 mgfrom 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/NCT01718509
NCT01718509Phase 3Completed
CompareCT.gov

The SPD489-344, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Shire·interventional·Posted Oct 31, 2012·Updated Jul 16, 2021

In Brief

A Phase 3 clinical trial evaluating SPD489 (Lisdexamfetamine dimesylate) and Placebo for Binge Eating Disorder. Completed, enrolled 390 participants across 48 sites in 2 countries.

Detailed Summary

The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBinge Eating Disorder
CountriesGermany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2012
Enrollment StartNov 26, 2012
Primary CompletionSep 20, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.7 years ago

Interventions

SPD489 (Lisdexamfetamine dimesylate)drug

50 or 70 mg administered orally, once-daily for up to 12 weeks

Placebodrug

Administered once-daily, orally, for up to 12 weeks