Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome - Full Text View

Purpose

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) in patients with Restless Legs Syndrome.

Condition	Intervention	Phase
Sleep Disorder Restless Legs Syndrome	Drug: Istradefylline (KW-6002)	Phase II

MedlinePlus related topics:

Restless Legs Sleep Disorders

Drug Information available for:

Istradefylline

U.S. FDA Resources

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

Official Title:	A Phase 2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) in Subjects With Restless Legs Syndrome

Further study details as provided by Kyowa Pharmaceutical:

Primary Outcome Measures:

Change from baseline in an RLS rating scale score at endpoint (6 weeks of treatment or early discontinuation).

Secondary Outcome Measures:

Change from baseline values in an RLS rating scale score, in the a sleepiness scale, in values for Clinical Global Impression, in quality of life, and in actigraphic measurements.
Safety

Estimated Enrollment:	160
Study Start Date:	July 2005
Estimated Study Completion Date:	September 2006

Detailed Description:

Restless Legs Syndrome (RLS) is a very common neurological disorder with a prevalence of approximately 10% in the adult population. It is characterized by an almost irresistible urge to move the legs, usually accompanied by feelings of intense discomfort. The feelings are usually present while at rest and are temporarily relieved by activity. Symptoms are worse in the evening and at night and lead to profound sleep disturbance and daytime fatigue.

Although a number of therapeutic approaches have been used to treat the symptoms of RLS, none have been universally adopted. While it has been shown that some dopaminergic anti-parkinsonian medications are effective in treating RLS, their use may be somewhat limited by side effects associated with long-term dopaminergic activation. Istradefylline may provide a nondopaminergic approach to the treatment of RLS.

This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of RLS with placebo.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

RLS that is mild to moderate in severity, non-nursing and non-pregnant if female, with an otherwise normal examination.

Exclusion Criteria:

Unable to stop other RLS medication, treatment with excluded medications, abnormal medical status.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199446

Locations


United States, New Jersey
	Kyowa Pharmaceutical Inc.
	Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Kyowa Pharmaceutical

Investigators


Study Director:	James Williams, MD	Kyowa Pharmaceutical

More Information

Study ID Numbers:	6002-US-201
First Received:	September 13, 2005
Last Updated:	February 27, 2007
ClinicalTrials.gov Identifier:	NCT00199446
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kyowa Pharmaceutical:

Sleep -Sleep Disorder

Sleep- Restless Legs Syndrome

Clinical Trial

Study placed in the following topic categories:

Signs and Symptoms

Ekbom syndrome

Mental Disorders

Restless Legs Syndrome

Neurologic Manifestations

Dyssomnias

Sleep Disorders

Psychomotor Agitation

Neurobehavioral Manifestations

Dyskinesias

Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Parasomnias

Nervous System Diseases

Psychomotor Disorders

ClinicalTrials.gov processed this record on October 21, 2008

Sponsored by:	Kyowa Pharmaceutical
Information provided by:	Kyowa Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00199446