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NCT01530386 · ClinicalTrials.gov registry record · Phase 1
A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects
A Phase 1 study of Healthy Subjects, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 4
- Study locations
NCT01530386: Completed Phase 1 study of Healthy Subjects, sponsored by UCB Pharma.
NCT01530386 is a Phase 1 study of Healthy Subjects that has completed, run by UCB Pharma. The registered enrollment target is 25 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (80% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01530386, a Phase 1 study of Healthy Subjects, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 4
- Study locations
Study Summary
The effects of Lacosamide, an antiepileptic drug, on sleep have not been formally evaluated. The present study is being conducted to assess the effects of Lacosamide on sleep quality in healthy subjects.
Primary Outcome
Wake after sleep onset is defined as the total time that is scored as awake in a polysomnography occurring between sleep onset and final wake-up.
Conditions Studied
Interventions
- DRUG Lacosamide
Study Locations (4)
Arkansas
- 005 - Little Rock
Ohio
- 003 - Cleveland
Texas
- 004 - Austin
Virginia
- 001 - Fredericksburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
What the finished NCT01530386 record still lists
NCT01530386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention - of which Lacosamide is the first listed.
NCT01530386 reports a single indexed study location in Arkansas, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT01530386 about?
NCT01530386 is a clinical study titled "A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects". The effects of Lacosamide, an antiepileptic drug, on sleep have not been formally evaluated. The present study is being conducted to assess the effects of Lacosamide on sleep quality in healthy subjects.
What is the current status of trial NCT01530386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2012-01. Estimated completion is 2012-07.
What conditions does trial NCT01530386 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT01530386?
The interventions under investigation include: Lacosamide (DRUG).
Who is sponsoring clinical trial NCT01530386?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01530386 being conducted?
This trial has 4 study locations across Arkansas, Ohio, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01530386's enrollment target sits among peer trials
25 45th of 69 higher than 25 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects 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.
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