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NCT01718483 · ClinicalTrials.gov registry record · Phase 3
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
- 383
- Enrollment target
NCT01718483: Completed Phase 3 study, sponsored by Shire.
NCT01718483 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 383 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01718483, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 383 participants
- Enrollment target
Study 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
Primary Outcome
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.
Interventions
- DRUG Placebo
- DRUG SPD489 (Lisdexamfetamine dimesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2012-11-26 |
| Est. Completion | 2013-09-25 |
| Phase | Phase 3 |
What the finished NCT01718483 record still lists
NCT01718483 is an interventional study that assigns participants to a tested intervention. The registered 383 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 (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01718483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01718483 about?
NCT01718483 is a clinical study titled "SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder". 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...
What is the current status of trial NCT01718483?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 383 participants. The study started on 2012-11-26. Estimated completion is 2013-09-25.
What interventions are being tested in trial NCT01718483?
The interventions under investigation include: Placebo (DRUG), SPD489 (Lisdexamfetamine dimesylate) (DRUG).
Who is sponsoring clinical trial NCT01718483?
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 NCT01718483's enrollment target sits among peer trials
383 976th of 2000 higher than 1,023 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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