Parkinson's Disease
Conditions
Interventions
Product Name: Rotigotine
Product Code: SPM 962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: [99755-59-6]
Current Sponsor code: SPM 962
Other descriptive name: (6S
Sponsors
Schwarz BioSciences Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Subject has an ongoing serious adverse event in trial SP515 that is assessed as related to study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of long-term treatment of rotigotine in subjects with 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. - Changes from baseline in the vital signs, body weight, electrocardiograms, clinical laboratory values, and Epworth Sleepiness Scale scores over the course of the trial. - Changes from baseline in physical and neurological examination data over the course of the trial. - Plasma levels of rotigotine (in approximately 20% of the trial population) over the course of the trial. | — |
Countries
Czech Republic, Finland, Hungary, Italy, Spain, Sweden
Outcome results
None listed