Rotigotine Restless Legs Syndrome Dose Finding Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00243217
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : September 25, 2014
Information provided by:
UCB Pharma

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.

Condition or disease Intervention/treatment Phase
Idiopathic Restless Leg Syndrome Drug: SPM 936 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Rotigotine
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00243217

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

Additional Information:
Publications of Results: Identifier: NCT00243217     History of Changes
Other Study ID Numbers: SP0709
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2009

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs