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

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ClinicalTrials.gov Identifier: NCT00199446
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 13, 2016
Information provided by:
Kyowa Kirin Pharmaceutical Development, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Disorder Restless Legs Syndrome Drug: Istradefylline (KW-6002) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : July 2005
Primary Completion Date : August 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. 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.
  2. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00199446

United States, New Jersey
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development, Inc.
Study Director: James Williams, MD Kyowa Kirin Pharmaceutical Development, Inc.

ClinicalTrials.gov Identifier: NCT00199446     History of Changes
Other Study ID Numbers: 6002-US-201
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:
Sleep -Sleep Disorder
Sleep- Restless Legs Syndrome
Clinical Trial

Additional relevant MeSH terms:
Sleep Wake Disorders
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs