Restless Legs Syndrome MedDRA version: 9.1 Level: LLT Classification code 10058920 Term: Restless legs syndrome
Conditions
Interventions
Product Code: ND1890
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-59-6
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration nu
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 understands the investigational nature of the trial and is willing and able to comply with the trial requirements. 3. Subject is male or female, aged = 18 years. 4. Subject meets the diagnosis of idiopathic RLS based on the 4 cardinal clinical features according to the IRLSSG: a An urge to move legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs (The urge to move can be present without uncomfortable sensations. Arms or other body parts can also be affected.). b The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting. c The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. d The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present.). 5. Subject has had an initial response to oral dopaminergic treatment for RLS and is not satisfactorily controlled on pramipexole or ropinirole 6. Subject has been on treatment with either pramipexole (up to 0,54mg of base/day respectively up to 0.75mg of salt/day) or ropinirole (up to 4mg/day) for >/= 28 days prior to Baseline visit (current dose should be stable for a minimum of 28 days and should be covered by the labeled total daily dose for RLS). 7. The subject’s body mass index is = 18kg/m2 and = 35kg/m2. 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 shown symptoms of augmentation with the current dopaminergic therapy with pramipexole or ropinirole. 2. Subject has secondary RLS (e.g., due to renal insufficiency [uremia], iron deficiency anemia or low ferritin (Ferritin 2.0mg/dL). 14. Subject has clinically relevant hepatic dysfunction (total bilirubin >2.0mg/dL or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 2 times the upper limit of the reference range). 15. Subject has a malignant neoplastic disease requiring therapy within 12 months prior to Screening Visit (SCR). 16. Subject is currently receiving treatment with any of the following drug classes: neuroleptics, hypnotics, anxiolytic drugs, anticonvulsive therapy, opioids, benzodiazepines, monoamine oxidase (MAO) inhibitors, catechol-O-methyl- transferase (COMT) inhibitors, sedative antihistamines, psychostimulates, or amphetamines. If subject has received such therapy, a washout period of at least 7 days prior to Baseline (BSL) is required before starting treatment in this trial. 17. Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to explore the practicability and tolerability of switching subjects overnight from ropinirole or pramipexole to rotigotine transdermal patch and its effect on symptoms in subjects with idiopathic restless legs syndrome. ;Secondary Objective: ;Primary end point(s): Practicability and Tolerability • Investigators assessment of practicability (IAP) • Tolerability of rotigotine as determined by the total number of subjects completing the trial: • from Baseline to Day 28 and to End of Treatment • on their original treatment dose assignment from Baseline to Day 28 and to End of Treatment • with at least one (1) dose adjustment from Baseline to Day 28 and to End of Treatment • Global Rating of Tolerability by the subject Safety Measured variables and changes over the course of trial will be performed on the following assessments, as appropriate: • Frequency and severity of adverse events (AEs), as reported spontaneously by the subject or observed by the investigator • Vital signs • 12 –lead electrocardiograms (ECGs) • Clinical laboratory values (hematology, serum chemistry, endocrine parameters, and urinalysis) • Physical and neurological examination findings • Clinical Global Impression (CGI) Item 4 • Assessment of augmentation • Subject’s rating of daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS) • Changes in menstrual and sexual function • Adhesiveness of the patch • Application site assessment Efficacy Measured variables, changes from Baseline and responder/remitter analyses will be performed on the following assessments, as appropriate: • International Restless Legs Scale (IRLS) sum score • CGI (Item 1-3) • RLS-6 Rating Scales • Global rating of efficacy by the subject Patient Treatment Preference, Satisfaction and Health outcomes va | — |
Countries
United Kingdom
Outcome results
None listed