At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 604 enrolled
Drug / intervention
Lisdexamfetamine dimesylatedrug
Likely dose
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.
A Phase 3, Multicenter, Open-label, 12 Month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults With Binge Eating Disorder
In Brief
A Phase 3 clinical trial evaluating Lisdexamfetamine dimesylate for Binge Eating Disorder. Completed, enrolled 604 participants across 89 sites in 3 countries.
Detailed Summary
To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBinge Eating Disorder
CountriesGermany, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartAug 2012
Primary CompletionOct 2014
TodayJul 2026
First PostedAug 3, 2012
Enrollment StartAug 21, 2012
Primary CompletionOct 21, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.9 years ago
Interventions
Lisdexamfetamine dimesylatedrug
50 or 70 mg administered orally, once a day for 52 weeks