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Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00498108
First received: July 6, 2007
Last updated: September 9, 2009
Last verified: September 2009
History of Changes
  Purpose

This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year in subjects who previously participated in SP790 (6-month pivotal trial) or SP794 (sleep lab trial). Subjects who successfully completed the Maintenance Period and the Taper Period of SP790 or SP794 are allowed to enroll in this trial.


Condition Intervention Phase
Idiopathic Restless Legs Syndrome
 Drug: Rotigotine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Trial to Investigate the Safety and Tolerability of Long-term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Resource links provided by NLM:

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

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Adverse events, changes in laboratory tests, vital signs, physical and neurological examination, menstrual and sexual function, 12-lead ECGs. Subject's rating of daytime sleepiness, global subject rating of tolerability

Secondary Outcome Measures:
  • Change in the International Restless Legs Scale (IRLS) sum score, in CGI Items 1 and 2-3, in RLS-6 Rating Scales. IRLS Responder [ Time Frame: from Baseline at the end of the Maintenance Period ]

Enrollment: 341
Study Start Date: January 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (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:

  • Subject completed the Maintenance Period and Taper Period of SP790 or SP794

Exclusion Criteria:

  • Subject has an ongoing serious adverse event (SAE) from SP790 or SP794 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
  • Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498108

Locations
Germany
Kassel, Germany, 34128
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00498108     History of Changes
Other Study ID Numbers: SP791, EudraCT Number: 2005-002611-25
Study First Received: July 6, 2007
Last Updated: September 9, 2009
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
Rotigotine
Restless Legs Syndrome

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

ClinicalTrials.gov processed this record on May 19, 2013