A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER

• Conditions: Patient with Idiopathic Parkinson Diesease; MedDRA version: 9.1Level: LLTClassification code 10061536Term: Parkinson's disease

• Registration Number: EUCTR2006-006907-35-IT
• Lead Sponsor: SCHWARZ PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-20
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Subjects must fulfill the following 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

Subjects are not permitted to enroll in the trial if any of the following criteria are met 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
Main Objective: The objective of this open-label extension is to assess the safety and tolerability of long-term treatment with rotigotine trandermal patch. Further effects on sleep quality, nocturnal and non-motor symptoms of Parkinson s disease will be evaluated.;Secondary Objective: The objective of this open-label extension is to assess the safety and tolerability of long-term treatment with rotigotine trandermal patch. Further effects on sleep quality, nocturnal and non-motor symptoms of Parkinson s disease will be evaluated.;Primary end point(s): The objective of this open-label extension is to assess the safety and tolerability of long-term treatment with rotigotine trandermal patch. Further effects on sleep quality, nocturnal and non-motor symptoms of Parkinson s disease will be evaluated.