Status:
COMPLETED
Rotigotine Restless Legs Syndrome Dose Finding Trial
Lead Sponsor:
UCB Pharma
Conditions:
Idiopathic Restless Leg Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch siz...
Eligibility Criteria
Inclusion
- Idiopathic Restless Leg Syndrome
- Subject has responded previously, according to medical history information, to L-Dopa therapy and/or treatment with a dopamine agonist, if pre-treated
Exclusion
- Secondary restless legs syndrome due to, e.g., renal insufficiency (uremia), iron deficiency anemia, rheumatoid arthritis.
- Secondary restless legs syndrome associated with previous or concomitant therapy with dopamine D2 receptor antagonists, butyrophenones, metoclopramid, atypical antipsychotics (e.g., olanzapine), tri- and tetracyclic antide-pressants, mianserine, lithium or H2-blockers (e.g., cimetidine), or due to withdrawal from drugs such as anticonvulsants, benzodiazepines, barbitur-ates, and other hypnotics.
- History of sleep disturbances like sleep apnea syndrome, narcolepsy, myoclonus epilepsy observed during polysomnography (PSG) or explored in subject history.
- Clinically relevant cardiac dysfunction and/or arrhythmias (e.g., suspected conduction system dysregulations, second or third degree AV block, complete left or right bundle branch block, sick-sinus-syndrome, congestive heart failure Class III or IV by NYHA, myocardial infarction within twelve months prior to enrollment).
- Clinically relevant renal dysfunction (serum creatinine \>2.0 mg/dl)
- Clinically relevant hepatic dysfunction (total bilirubin \>2.0 mg/dl or ALT and/or AST greater than two times the upper limit of the reference range).
- QTc-interval in resting ECG \> 450 msec in males and \> 470 msec in females.
- History of symptomatic orthostatic hypotension within 28 days prior to screening visit (Visit 1), or a systolic blood pressure (SBP) less than 105mmHg at trial entry.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT00243217
Start Date
April 1 2003
End Date
February 1 2004
Last Update
September 25 2014
Active Locations (1)
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1
Schwarz
Monheim, Germany