Parkinson's disease MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Trade Name: Neupro 2mg/24h transdermal patch
Product Code: ND1587
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Conc
Sponsors
Schwarz Biosciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 trial SP889. 4. Subject, in the opinion of the investigator, would benefit from long-term treatment of rotigotine. 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: 1. Subject has an ongoing serious AE that is assessed as related to trial medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson’s disease. ;Secondary Objective: The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.;Primary end point(s): • Change from Baseline in Total UPDRS Part II (Activities of Daily Living) score over the course of the trial • Change from Baseline in UPDRS Part III score over the course of the trial • Change from Baseline in Total UPDRS Part IV (Complications of Therapy) score over the course of the trial • Change from Baseline in Short-form Parkinson’s Disease Questionnaire (PDQ-8) over the course of the trial • Change from Baseline in number of nocturias over the course of the trial • Change from Baseline in the Parkinson’s Disease Sleep Scale (PDSS) over the course of the trial • Change from Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) over the course of the trial • Change from Baseline in the Likert Pain Scale over the course of the trial • Change from Baseline in Parkinson’s Disease Non-Motor Symptom Assessment Scale (PDNMS) over the course of the trial • Change from Baseline in Beck Depression Inventory (BDI-II) over the course of the trial • Frequency and severity of AEs, as reported spontaneously by the subject or observed by the investigator, recorded over the course of the trial • Change in vital signs, weight, ECGs, and clinical laboratory values over the course of the trial • Changes in physical and neurological examination data over the course of the trial Baseline for this open-label extension trial is defined as the subject’s Baseline in SP889. | — |
Countries
Austria, Finland, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed