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NCT01163032 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
A Phase 3 study, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
NCT01163032: Completed Phase 3 study, sponsored by Vanda Pharmaceuticals.
NCT01163032 is a Phase 3 study that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 136 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01163032, a Phase 3 study, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder
Primary Outcome
Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four 48 hour periods , collected approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.
Interventions
- DRUG Placebo
- DRUG tasimelteon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01163032 record still lists
NCT01163032 is an interventional study that assigns participants to a tested intervention. The registered 136 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 (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01163032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01163032 about?
NCT01163032 is a clinical study titled "Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder". The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder
What is the current status of trial NCT01163032?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2010-08. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01163032?
The interventions under investigation include: Placebo (DRUG), tasimelteon (DRUG).
Who is sponsoring clinical trial NCT01163032?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01163032's enrollment target sits among peer trials
136 1580th of 2000 higher than 419 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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