Trials / Completed
CompletedNCT00243217
Rotigotine Restless Legs Syndrome Dose Finding Trial
Multi-center, Double-blind, Randomized, Placebo-controlled, Six-arm, Parallel-group, Dose-finding Trial to Determine Efficacy, Safety and Tolerability of Five Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 341 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936) will be more effective than placebo. The tolerability and safety of rotigotine will be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPM 936 |
Timeline
- Start date
- 2003-04-01
- Primary completion
- 2004-02-01
- Completion
- 2004-02-01
- First posted
- 2005-10-21
- Last updated
- 2014-09-25
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00243217. Inclusion in this directory is not an endorsement.