Rotigotine Restless Legs Syndrome Dose Finding Trial

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: October 20, 2005
Last updated: September 24, 2014
Last verified: September 2009
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.

Condition Intervention Phase
Idiopathic Restless Leg Syndrome
Drug: SPM 936
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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. ]

Enrollment: 341
Study Start Date: April 2003
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00243217

Monheim, Germany
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications: Identifier: NCT00243217     History of Changes
Other Study ID Numbers: SP0709 
Study First Received: October 20, 2005
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders processed this record on May 25, 2016