Phase 3
Completed N=186
An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease
Source: ClinicalTrials.gov NCT00505687 ↗Enrolled (actual)
186
Serious AEs
24.2%
Results posted
Jan 2010
Primary outcomePrimary: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study — 170 Subjects
Summary
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Adverse Event During This Open-label Extension Study |
170 | — |
| SECONDARY Number of Subjects Who Withdrew From the Trial Due to an Adverse Event |
48 | — |
| SECONDARY Mean Epworth Sleepiness Scale Score During the Open-label Extension. |
9.3; 10.0; 10.3; 10.1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed treatment in one of the SP824 (NCT00242008), SP825 (NCT00243971), or SP826 (NCT00243945) trials
Exclusion Criteria
- Subjects who had an ongoing serious adverse event from the previous OLE trial that was assessed as related to study medication
Data sourced from ClinicalTrials.gov (NCT00505687). 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.