A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease
Phase 1
- Conditions
- Parkinson's disease
- Registration Number
- EUCTR2004-002641-12-GB
- Lead Sponsor
- Schwarz Biosciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
1. Subject is informed and given ample time and opportunity to think about her/his
participation and has given her/his written informed consent.
2. Subject is willing and able to comply with all trial requirements.
3. Subject has completed Study SP824, SP825, or SP826.
4. Subject, in the opinion of the investigator, would benefit from long-term treatment
of rotigotine.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Subject has an ongoing serious adverse event that is assessed as related to
study medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method