Phase 3
Completed N=395
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease
Advanced Stage Parkinson's Disease
Source: ClinicalTrials.gov NCT00501969 ↗
Enrolled (actual)
395
Serious AEs
37.5%
Results posted
Jan 2010
Primary outcomePrimary: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study — 357 Subjects
Summary
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Adverse Event During This Open-label Extension Study |
357 | — |
| SECONDARY Number of Subjects Who Withdrew From the Trial Due to an Adverse Event |
76 | — |
| SECONDARY Mean Epworth Sleepiness Scale Score During the Open-label Extension |
7.4; 7.8; 8.0; 8.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial
Exclusion Criteria
- Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) double-blind trial that was assessed as related to study medication
Data sourced from ClinicalTrials.gov (NCT00501969). 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.