Idiopathic restless legs syndrome
Conditions
Interventions
Product Name: Rotigotine
Product Code: SPM 936
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-
Sponsors
SCHWARZ BIOSCIENCES GmBH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and tolerability of long-term treatment with transdermal rotigotine in subjects with idiopathic restless legs syndrome ;Secondary Objective: To obtain data on changes in severity in RLS symptoms and quality of life under rotigotine treatment during long-term exposure ; Primary end point(s): - AEs reported spontaneuously by the subject or observed by the investigator - AE of special interest: sleep attacks / sudden onset of slepp (defined as abrupt episodes of unplanned sleep during activities of daily living where they are not expected to occur. These events may or may not be preceded by somnolence or sedation.) - Cahnges in laboratory tests (haematology, blood chemistry, endocrine parameters and urinalysis) - Changes in vital signs (including orthostatic assessment) - Physical and neurological examination findings - Changes in menstrual and sexual function - Changes in 120lead ECGs - Subject's rating of daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS) - Global Subject Rating of Tolerability - Clinical Global Impression (CGI) Item 4 | — |
Countries
Austria, Finland, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed