A mulit-center, randomized, double-blind, placebo-controlled, four-arm parallel group trial to investigate the efficacy and safety of three different transdermal doses of rotigotine in subjects with idiopathic restless legs syndrome
- Conditions
- Restless Leg's SyndromeMedDRA version: 7.0 Level: LLT Classification code 10058920
- Registration Number
- EUCTR2005-000428-18-GB
- Lead Sponsor
- Schwarz Biosciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
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. Subject is willing to accept that he/she
might be treated with placebo during the treatment period.
3. Subject is able to apply/remove the trial patches correctly and consistently.
4. Subject is male or female, and is =18 and =75 years of age.
5. 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.).
6. Subject has had an initial response to previous dopaminergic treatment for RLS or
has had no previous dopaminergic treatment (ie, de novo).
7. The subject’s body mass index is =18kg/m2 and =35kg/m2.
8. At Baseline (Visit 2), subject has a score of =15 on the IRLS (indicating moderate
to severe RLS).
9. At Baseline (Visit 2), subject scores =4 points on the CGI Item 1 assessment
(indicating at least moderately ill).
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 secondary RLS (eg, due to renal insufficiency [uremia], iron
deficiency
anemia, or rheumatoid arthritis).
2. Subject has secondary RLS associated with previous or concomitant therapy with
dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical
antipsychotics (eg, olanzapine), tri- and tetra-cyclic antidepressants, mianserine,
lithium, or due to withdrawal from drugs such as anticonvulsants,
benzodiazepines, barbiturates, and other hypnotics.
3. Subject has a current history of sleep disturbances like sleep apnea syndrome,
narcolepsy, sleep attacks/sudden onset of sleep, or myoclonus epilepsy either
observed during polysomnography or evidenced by subject history.
4. Subject has additional clinically relevant concomitant diseases such as
polyneuropathy, akathisia, claudication, varicosis, muscle fasciculation, painful
legs and moving toes, or radiculopathy.
5. Subject has other central nervous system diseases such as Parkinson’s disease,
dementia, progressive supranuclear paresis, multisystem atrophy, Huntington’s
Chorea, amyotrophic lateral sclerosis, or Alzheimer’s disease.
6. Subject has a prior history of psychotic episodes.
7. Subject has a history of chronic alcohol or drug abuse within the last 12 months.
8. Subject has any medical or psychiatric condition, which in the opinion of the
investigator, can jeopardize or would compromise the subject’s ability to
participate in this trial.
9. Subject has clinically relevant cardiac dysfunction and/or arrhythmias (eg,
suspected conduction system dysregulations, second or third degree AV block,
complete left or right bundle branch block, sick-sinus-syndrome, New York Heart
Association Class III or IV congestive heart failure, or has had a myocardial
infarction within 12 months prior to Screening [Visit 1]).
10. Subject has clinically relevant venous or arterial peripheral vascular disease.
11. Subject has clinically relevant renal dysfunction (serum creatinine >2.0mg/dL)
12. 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).
13. Subject has a malignant neoplastic disease requiring therapy within 12 months
prior to Screening (Visit 1).
14. Subject is currently receiving treatment with any of the following drug classes:
neuroleptics, hypnotics, antidepressants, 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 (Visit 2) is required before
starting treatment in this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to demonstrate efficacy of rotigotine against placebo in subjects with idiopathic RLS over a 6-month maintenance period;Secondary Objective: to investigate the safety and tolerability of rotigotine;<br> Primary end point(s): Primary variables:<br> Efficacy will be assessed by the absolute change from Baseline at the end of the Maintenance Period in the IRLS sum score and the CGI Item 1 (severity of illness) score.<br>
- Secondary Outcome Measures
Name Time Method