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NCT01718509 · 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
- 390
- Enrollment target
NCT01718509 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 390 participants.
The verdict
NCT01718509, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 390 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
Interventions
- DRUG Placebo
- DRUG SPD489 (Lisdexamfetamine dimesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2012-11-26 |
| Est. Completion | 2013-09-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01718509
The ClinicalTrials.gov registry entry for NCT01718509 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01718509 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01718509 about?
NCT01718509 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 NCT01718509?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2012-11-26. Estimated completion is 2013-09-20.
What interventions are being tested in trial NCT01718509?
The interventions under investigation include: Placebo (DRUG), SPD489 (Lisdexamfetamine dimesylate) (DRUG).
Who is sponsoring clinical trial NCT01718509?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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