At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 271 enrolled
Drug / intervention
lisdexamfetamine dimesylate (SPD489) +3 moredrug
Likely dose
lisdexamfetamine dimesylate (SPD489) 30mgfrom 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 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Binge Eating Disorder
In Brief
A Phase 2 clinical trial evaluating lisdexamfetamine dimesylate (SPD489) and Placebo for Binge Eating Disorder. Completed, enrolled 271 participants across 31 sites.
Detailed Summary
To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBinge Eating Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2011
Enrollment StartMay 2011
Primary CompletionJan 2012
TodayJul 2026
First PostedFeb 8, 2011
Enrollment StartMay 10, 2011
Primary CompletionJan 30, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.4 years ago
Interventions
lisdexamfetamine dimesylate (SPD489)drug
SPD489-30mg capsules taken once daily for up to 11 weeks
lisdexamfetamine dimesylate (SPD489)drug
SPD489 50mg capsules taken once-daily for up to 11 weeks
lisdexamfetamine dimesylate (SPD489)drug
SPD489 70mg capsule taken once-daily for up to 11 weeks
Placebodrug
Placebo capsule taken once daily for up to 11 weeks