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Rotigotine Restless Legs Syndrome Dose Finding Trial
This study has been completed.
First Received: October 20, 2005   Last Updated: August 4, 2008   History of Changes
Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00243217
  Purpose

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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243217

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

Publications:
Study ID Numbers: SP709
Study First Received: October 20, 2005
Last Updated: August 4, 2008
ClinicalTrials.gov Identifier: NCT00243217     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neurotransmitter Agents
Sleep Disorders
Dyssomnias
Psychomotor Agitation
Dopamine Agonists
Dyskinesias
Sleep Disorders, Intrinsic
Signs and Symptoms
Dopamine
Mental Disorders
Restless Legs Syndrome
Neurologic Manifestations
Dopamine Agents
Neurobehavioral Manifestations
N 0437

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Parasomnias
Dyssomnias
Sleep Disorders
Psychomotor Agitation
Dopamine Agonists
Dyskinesias
Pharmacologic Actions
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Syndrome
Restless Legs Syndrome
Psychomotor Disorders
Neurologic Manifestations
Dopamine Agents
Neurobehavioral Manifestations
N 0437

ClinicalTrials.gov processed this record on September 10, 2009