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
- Conditions
- Restless Leg's SyndromeMedDRA version: 7.0Level: LLTClassification code 10058920
- Registration Number
- EUCTR2005-002611-25-AT
- Lead Sponsor
- Schwarz Biosciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
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 completed the 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
1. Subject has an ongoing serious adverse event (SAE) 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 child-bearing potential who is not surgically sterile, 2 years postmenopausal, 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 or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject’s ability to participate in this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method