Phase 3
Completed N=381
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease
Early Stage Parkinson's Disease
Source: ClinicalTrials.gov NCT00599196 ↗
Enrolled (actual)
381
Serious AEs
34.5%
Results posted
Jan 2010
Primary outcomePrimary: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study — 369 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 early-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 |
369 | — |
| SECONDARY Number of Subjects Who Withdrew From the Trial Due to an Adverse Event |
93 | — |
| SECONDARY Mean Epworth Sleepiness Scale Score During the Open-label Extension |
5.8; 6.2; 6.7; 6.7; 6.7; 6.8 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial
Exclusion Criteria
- Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication
Data sourced from ClinicalTrials.gov (NCT00599196). 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.