Phase 3
Completed N=217
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 NCT00594165 ↗
Enrolled (actual)
217
Serious AEs
47.2%
Results posted
Feb 2010
Primary outcomePrimary: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study — 214 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 |
214 | — |
| SECONDARY Number of Subjects Who Withdrew From the Trial Due to an Adverse Event. |
52 | — |
| SECONDARY Mean Epworth Sleepiness Scale Score During the Open-label Extension. |
7.3; 7.9; 8.2; 8.4; 8.8; 8.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed six months of maintenance treatment in the SP512 double-blind trial
Exclusion Criteria
- Subjects who had an ongoing serious adverse event from SP512 double-blind trial that was assessed as related to study medication
Data sourced from ClinicalTrials.gov (NCT00594165). 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.