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NCT00135993 · ClinicalTrials.gov registry record · Phase 3
Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
A Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 811
- Enrollment target
NCT00135993 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 811 participants.
The verdict
NCT00135993, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 811 participants
- Enrollment target
Study Summary
Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial. The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine. Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).
Interventions
- DRUG Rotigotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 811 participants |
| Start Date | 2005-05 |
| Est. Completion | 2006-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00135993
The ClinicalTrials.gov registry entry for NCT00135993 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 811 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCB Pharma, which has 100 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rotigotine is the first listed.
NCT00135993 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00135993 about?
NCT00135993 is a clinical study titled "Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome". Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial. The primary objective of this trial is to demonstrate that rotigotine ...
What is the current status of trial NCT00135993?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 811 participants. The study started on 2005-05. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00135993?
The interventions under investigation include: Rotigotine (DRUG).
Who is sponsoring clinical trial NCT00135993?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
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