Phase 3
Completed N=287
Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
Source: ClinicalTrials.gov NCT00474058 ↗Enrolled (actual)
287
Serious AEs
5.2%
Results posted
Apr 2010
Primary outcomePrimary: Change in Early Morning UPDRS Part III Score — -7.0; -3.9 units on a scale — p=0.0002
Summary
The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Early Morning UPDRS Part III Score |
-7.0; -3.9 | 0.0002 sig |
| PRIMARY Change in Parkinson's Disease Sleep Scale (PDSS) |
-5.9; -1.9 | <0.0001 sig |
| SECONDARY Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) |
-1.3; -0.9 | 0.0301 sig |
| SECONDARY Change in Number of Nocturias |
-0.3; -0.2 | 0.8842 |
Eligibility Criteria
Inclusion Criteria
- Early and advanced Idiopathic Parkinson Disease with early morning motor impairment
Exclusion Criteria
- Atypical Parkinsonian syndromes
Data sourced from ClinicalTrials.gov (NCT00474058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.