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Trial record 1 of 1 for:    NCT00263068
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An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome

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ClinicalTrials.gov Identifier: NCT00263068
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : September 25, 2014
Information provided by:
UCB Pharma

Brief Summary:

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 or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Rotigotine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Rotigotine

Arm Intervention/treatment
Experimental: 1
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

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 ClinicalTrials.gov identifier (NCT number): NCT00263068

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United States, North Carolina
RTP, North Carolina, United States
Sponsors and Collaborators
UCB Pharma
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
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Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00263068    
Other Study ID Numbers: SP0793
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2009
Keywords provided by UCB Pharma:
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs