Transdermal lisuride:Phase II/III study (efficacy and tolerance) of transdermal lisuride (patches) in patients with Restless Legs Syndrome (RLS)
- Conditions
- Patients suffering from Restless Legs Syndrome (RLS)
- Registration Number
- EUCTR2004-001589-42-AT
- Lead Sponsor
- euroBiotec GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
- Male and female patients, between 18 and 80 (inclusive) years of age.
- Diagnosis of idiopathic or uremic restless legs syndrome based on the four essential clinical features according to the International Restless Legs Study Group (IRLSSG).
- RLS Diagnostic Index (RLS-DI) >= 10
- Total score in the IRLS Rating Scale >= 15 at baseline
- RLS-6 score severity during the day at rest) >= 3
- Patient has no previous treatment for RLS (de novo patients) or patient is not well controlled with current therapy.
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. Secondary restless legs syndrome due to, eg, iron deficiency anemia, rheumatoid arthritis. However, patients with secondary RLS due to renal insufficiency (uremia) are allowed to participate in this study.
2. Secondary Restless Legs Syndrome due to previous or concomitant therapy with dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical antipsychotics (eg, olanzapine), tri- and tetracyclic antidepressants, mianserine, lithium or H2-blockers (eg, cimetidine), or due to withdrawal from drugs such as anticonvulsants, benzodiazepines, barbiturates and other hypnotics.
3. History of sleep disturbances like sleep apnea syndrome, narcolepsy, myoclonus epilepsy observed during PSG or explored in patient history.
4. Further clinically relevant concomitant diseases: polyneuropathy, akathisia, claudication, varicosis, painful leg and moving toes, radiculopathy, fibromyositis, severe chronic lung disease, insulin-dependent diabetes mellitus, leukemia, anemia, primary amyloidosis.
5. Other central nervous diseases such as: dementia, progressive supranuclear palsy, multi-system atrophy, Chorea Huntington, amyotrophic lateral sclerosis, dementia (eg, Alz-heimer’s disease), Isaac’s syndrome, Stiff-Man syndrome.
6. Use of drugs likely to influence sleep architecture or motor manifestations during sleep within the last week before baseline visit. These include levodopa, other dopamine ago-nists, neuroleptics, hypnotics (except oxazepam, see Section 8.6.3), benzodiazepines, MAO inhibitors, antidepressants (except SSRI and NARI), anxiolytic drugs, anticonvul-sants, psychostimulant medications, and opioides. Inclusion is possible, if a >= one week wash-out is performed (if medically acceptable) before baseline; for pre-treatments with dopamine agonists, a four-week washout period is required.
7. Myocardial infarction within 3 months before randomization; other clinically significant heart conditions (eg, instable coronary artery disease or other severe disturbances of pe-ripheral circulation and coronary insufficiency) and other severe health conditions for which it can be assumed that the effect of the study drugs will not be normal (eg, severe respiratory problems, hypothyreosis, active neoplastic disease).
8. History of hallucinating or psychotic episodes which had needed treatment (including schizophrenia).
9. Severe acute disease within the last 4 weeks prior to the first study drug administration.
10. Clinically relevant presence of iron deficiency (as a rule as indicated by measures of ferri-tine below the lower boundary of the central laboratory).
11. Clinically significant liver failure (total bilirubin >2.0mg/dl or SGOT and/or SGPT greater than two times the upper limit of the reference range).
12. Clinically relevant renal dysfunction (serum creatinine >2.0 mg/dl) except in patients with uremic RLS who need at least two, usually three hemodialyses per week.
13. Known hypersensitivity to lisuride or patches (band-aid, Leukoplast, Tesafilm (Scotch tape), etc).
14. Pretreatment with lithium carbonate within 2 months prior to screening.
15. Patients doing shift-work or is subject to other continuous non-disease-related life condi-tions which do not allow regular sleep at night .
16. Pregnancy or lactation.
17. Use of experimental drugs and/or participation in another clinical trial within 4 weeks be-fore study.
18. Suspected irregular application of medication.
19. Suspicion of present drug or alcohol abuse.
20. Inability
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary study objective is to investigate the efficacy of three different dosages of Lisuride TTS patches compared to placebo after 12 weeks of treatment in patients with idiopathic or uremic RLS. Changes in the IRLS total score are used as primary efficacy outcome measure.;Secondary Objective: The secondary study objectives are:<br>1) to evaluate quality of life, tolerability and safety of Lisuride TTS patch treatment in comparison to placebo after 12 weeks of double-blind treatment<br>2) to assess long-term efficacy, quality of life, tolerability, and safety of open-labeled treatment with Lisuride TTS patches after 12 months, and to determine the effective dosage of Lisuride TTS in open-labeled application. <br>;Primary end point(s): Changes between Baseline and Visit 6 (Week 12 / Day 85)<br>in the total score of the IRLS total score will be analyzed<br>as a primary endpoint, and compared against the 4 different groups.
- Secondary Outcome Measures
Name Time Method