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NCT00263068 · ClinicalTrials.gov registry record · Phase 3
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
A Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 279
- Enrollment target
NCT00263068 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 279 participants.
The verdict
NCT00263068, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 279 participants
- Enrollment target
Study Summary
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are allowed to enroll in this trial. All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2 patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments, initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of 6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although not all subjects will require 28 days to reach their optimal dose. A subject's dose may be increased or decreased, as needed by the investigator to maintain a subject's effective dose during the Maintenance Period. A Taper Period is provided to allow for safe, gradual withdrawal from trial medication
Interventions
- DRUG Rotigotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2005-12 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00263068
The ClinicalTrials.gov registry entry for NCT00263068 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 279 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.
NCT00263068 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00263068 about?
NCT00263068 is a clinical study titled "An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome". This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are a...
What is the current status of trial NCT00263068?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 279 participants. The study started on 2005-12. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00263068?
The interventions under investigation include: Rotigotine (DRUG).
Who is sponsoring clinical trial NCT00263068?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
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