Multi-center, Double-blind, Randomized, Placebo-controlled, Six-arm, Parallel-group, Dose-finding Trial to Determine Efficacy, Safety and Tolerability of Five Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome

UCB Pharma1 site in 1 country341 target enrollmentApril 2003

ConditionsIdiopathic Restless Leg Syndrome

DrugsSPM 936

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Idiopathic Restless Leg Syndrome
Sponsor: UCB Pharma
Enrollment: 341
Locations: 1
Primary Endpoint: International RLS Study Group Rating Scale (IRLS): absolute change from baseline to end of maintenance period in the IRLS sum score (difference Visit 7 minus Visit 2)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936) will be more effective than placebo. The tolerability and safety of rotigotine will be assessed.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

February 2004

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UCB Pharma

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Outcomes

Primary Outcomes

International RLS Study Group Rating Scale (IRLS): absolute change from baseline to end of maintenance period in the IRLS sum score (difference Visit 7 minus Visit 2)

Secondary Outcomes

RLS-6 Rating Scales,CGI (Clinical Global Impressions) - global rating of efficacy by the investigator,Subjective Rating of Efficacy by the subject, Quality of Life. ]