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NCT02009163 · ClinicalTrials.gov registry record · Phase 3
Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 418
- Enrollment target
NCT02009163: Completed Phase 3 study, sponsored by Shire.
NCT02009163 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 418 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02009163, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 418 participants
- Enrollment target
Study 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.
Primary Outcome
Relapse status was assessed during the double-blind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse - date of randomization). Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day,
Interventions
- OTHER Placebo
- DRUG Lisdexamfetamine dimesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2014-01-27 |
| Est. Completion | 2015-04-08 |
| Phase | Phase 3 |
What the finished NCT02009163 record still lists
NCT02009163 is an interventional study that assigns participants to a tested intervention. The registered 418 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02009163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02009163 about?
NCT02009163 is a clinical study titled "Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder". 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 Impressio...
What is the current status of trial NCT02009163?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 418 participants. The study started on 2014-01-27. Estimated completion is 2015-04-08.
What interventions are being tested in trial NCT02009163?
The interventions under investigation include: Placebo (OTHER), Lisdexamfetamine dimesylate (DRUG).
Who is sponsoring clinical trial NCT02009163?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02009163's enrollment target sits among peer trials
418 900th of 2000 higher than 1,099 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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