Purpose

This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are allowed to enroll in this trial.

All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2 patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments, initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of 6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although not all subjects will require 28 days to reach their optimal dose.

A subject's dose may be increased or decreased, as needed by the investigator to maintain a subject's effective dose during the Maintenance Period. A Taper Period is provided to allow for safe, gradual withdrawal from trial medication


Condition Intervention Phase
Restless Legs Syndrome
 Drug: Rotigotine
 Phase III

MedlinePlus related topics:   Restless Legs  

ChemIDplus related topics:   Rotigotine  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by UCB:

Primary Outcome Measures:
  • Safety and tolerability will be assessed by adverse events, changes in laboratory tests, changes in vital signs, physical and neurological examination, changes in menstrual and sexual function, global subject rating [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • To obtain data on changes in severity in RLS symptoms and quality of life over a one year maintenance period. [ Time Frame: 1 year ]

Enrollment:   279
Study Start Date:   December 2005
Study Completion Date:   December 2007
Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Up to 6.75 mg/day (optimal dosing)
Drug: Rotigotine

Transdermal Patch 1 per day for 24 hours containing:

1.125mg/day 2.25mg/day 4.5mg/day 6.75mg/day


  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

  • Idiopathic restless legs syndrome

Exclusion Criteria:

  • Subject has an ongoing serious adverse event from SP792 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
  • Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception, including at least 1 barrier method, unless sexually abstinent.
  • 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: NCT00263068

Locations
United States, North Carolina
Schwarz    
      RTP, North Carolina, United States

Sponsors and Collaborators
UCB

Investigators
Study Director:     UCB Clinical Trial Call Center     1 877 822 9493 (UCB)    
United States, North Carolina
Schwarz    
      RTP, North Carolina, United States
UCB
Study Director:     UCB Clinical Trial Call Center     1 877 822 9493 (UCB)    
  More Information

Responsible Party:   UCB ( Study Director )
Study ID Numbers:   SP793
First Received:   December 5, 2005
Last Updated:   March 7, 2008
ClinicalTrials.gov Identifier:   NCT00263068
Health Authority:   United States: Food and Drug Administration

Keywords provided by UCB:
IDIOPATHIC RESTLESS LEGS SYNDROME  

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

Additional relevant MeSH terms:
Restless Legs Syndrome
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Parasomnias
Physiological Effects of Drugs
Dopamine Agonists
Pharmacologic Actions
Pathologic Processes
Syndrome
Psychomotor Disorders
Dopamine Agents

Source: National Library of Medicine (NLM) July 09, 2008

  
 
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