Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00135993

Purpose

Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial.

The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome.

Additional objectives are to investigate the safety and tolerability of rotigotine.

Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: Rotigotine	Phase III

MedlinePlus related topics: Restless Legs

Drug Information available for: Rotigotine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Further study details as provided by UCB:

Primary Outcome Measures:

IRLS sum score and CGI Item 1 score severity of illness [ Time Frame: From Baseline at the end of the Maintenance Period ]

Secondary Outcome Measures:

IRLS Responder: A responder is a subject with a decrease of ≥50% in IRLS sum score [ Time Frame: From Baseline at the end of the Maintenance Period ]
CGI Item 1 Responder: A responder is defined as a subject with a decrease of ≥50% in CGI Item 1 [ Time Frame: From Baseline at the end of the Maintenance Period ]
Changes in CGI Items 2-3 (continuous) during the Maintenance Period; Change from Baseline in RLS-6 Rating Scales at the end of the Maintenance Period

Enrollment:	811
Study Start Date:	May 2005
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Idiopathic restless legs syndrome

Exclusion Criteria:

History of sleep disturbances

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135993

Locations

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

Sponsors and Collaborators

UCB

Investigators

Study Director:

John Whitesides

Schwarz Biosciences Inc.

More Information

No publications provided

Study ID Numbers:	SP792
Study First Received:	August 24, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00135993 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

Idiopathic Restless Leg syndrome

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 May 07, 2009