A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A
- Conditions
- Parkinson's Disease
- Registration Number
- EUCTR2004-000148-26-SE
- Lead Sponsor
- Schwarz BioSciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
- Subject is informed and given ample time and opportunity to think about his/her
participation in this trial and has given his/her written informed consent
- Subject is willing and able to comply with all trial requirements
- Subject has completed 4 months of maintenance treatment in the double-blind trial
SP515
Are the trial subjects under 18? no
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
- Subject has an ongoing serious adverse event in trial SP515 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 Main Objective: To assess safety and tolerability of rotigotine until rotigotine is commercially available or until the sponsor closes the trial, whichever comes first, in subjects with advance stage, idiopathic Parkinson's disease.;Secondary Objective: N/A;Primary end point(s): - Adverse events, as reported spontaneously by the subject or observed by the investigator recorded over the course of the trial.<br>- Changes from baseline in the vital signs, body weight, electrocardiograms, clinical laboratory values, and Epworth Sleepiness Scale scores over the course of the trial.<br>- Changes from baseline in physical and neurological examination data over the course of the trial.<br>- Plasma levels of rotigotine (in approximately 20% of the trial population) over the course of the first 12 months on maintenance in the trial.
- Secondary Outcome Measures
Name Time Method