Phase 3
Completed N=258
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease
Source: ClinicalTrials.gov NCT00594386 ↗Enrolled (actual)
258
Serious AEs
63.9%
Results posted
Dec 2009
Primary outcomePrimary: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study — 258 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 |
258 | — |
| SECONDARY Number of Subjects Who Withdrew From the Trial Due to an Adverse Event. |
68 | — |
| SECONDARY Mean Epworth Sleepiness Scale Score During the Open-label Extension. |
8.6; 8.9; 9.3; 9.8; 9.7; 10.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed six months of maintenance treatment in the SP650 double-blind trial
Exclusion Criteria
- Subjects who had an ongoing serious adverse event from the SP650 double-blind trial that was assessed as related to study medication
Data sourced from ClinicalTrials.gov (NCT00594386). 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.