An open label extension trial to investigate the safety and tolerability of long-term treatment with transdermal rotigotine in subjects with idiopathic restless legs syndrome

Phase 1

• Conditions: Idiopathic restless legs syndrome

• Registration Number: EUCTR2005-002611-25-GB
• Lead Sponsor: SCHWARZ BIOSCIENCES GmBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-26
• Study Completion: 2007-09-08
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 420

Inclusion Criteria

1. Subject is informed and given ample time / opportunity to think about participation and has given written consent
2. Subject completed Maintenance period and taper period of SP790 or SP794
3. Subject understands the investigational nature of the trial and is willing and able to comply with the trial requirements
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

1. Subject has an ongoing serious adverse event from sp790 or sp794 that is assessed to be related to the trial medication by the investigator and / or the sponsor
2. Subject is pregnant, nursing or is a woman of childbearing potential who is not surgically sterile, 2 years post-menopausal or does not consistently use 2 combined effective methods of contraception, including at least 1 barrier method, unless sexually abstinent
3. Subject has any medical condition that, in the opinion of the investigator, can jeopardise or would compromise the subject's ability to participate in the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified