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NCT01332318 · ClinicalTrials.gov registry record · Phase 2
Simulated Driving Study in Restless Legs Syndrome
A Phase 2 study of Restless Legs Syndrome, sponsored by XenoPort.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT01332318: Completed Phase 2 study of Restless Legs Syndrome, sponsored by XenoPort.
NCT01332318 is a Phase 2 study of Restless Legs Syndrome that has completed, run by XenoPort. The registered enrollment target is 130 participants, above the 87-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (49% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01332318, a Phase 2 study of Restless Legs Syndrome, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one of the placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of an agent known to have sedative properties, while the other 3 groups received a DPH placebo.
Primary Outcome
Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 16 mean LPV over the 1-hour drive minus the Baseline mean LPV over the 1-hour drive. The Day 16 measurement is at the time of maximum concentration (Tmax) for both GEn and DPH.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Diphenhydramine
- DRUG XP13512
Study Locations (1)
New Mexico
- GSK Investigational Site - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2007-04 |
| Est. Completion | 2007-11 |
| Phase | Phase 2 |
What the finished NCT01332318 record still lists
NCT01332318 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 87-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (49% higher).
The record links to 1 condition, with Restless Legs Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01332318 reports a single indexed study location in New Mexico.
Frequently Asked Questions
What is clinical trial NCT01332318 about?
NCT01332318 is a clinical study titled "Simulated Driving Study in Restless Legs Syndrome". This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose of placebo (2 groups), XP...
What is the current status of trial NCT01332318?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2007-04. Estimated completion is 2007-11.
What conditions does trial NCT01332318 study?
This clinical trial studies the following conditions: Restless Legs Syndrome.
What interventions are being tested in trial NCT01332318?
The interventions under investigation include: Placebo (DRUG), Diphenhydramine (DRUG), XP13512 (DRUG).
Who is sponsoring clinical trial NCT01332318?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01332318 being conducted?
This trial has 1 study location across New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Restless Legs Syndrome
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 NCT01332318's enrollment target sits among peer trials
130 4th of 14 higher than 11 of 14 other Restless Legs Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Restless Legs Syndrome 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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