Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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New Jersey
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Princeton, New Jersey, United States, 08540
- Kyowa Pharmaceutical Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline in an RLS rating scale score at endpoint (6 weeks of treatment or early discontinuation).
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Secondary Outcome Measures
Outcome Measure |
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Safety
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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.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: James Williams, MD, Kyowa Kirin, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Dyskinesias
- Psychomotor Disorders
- Aberrant Motor Behavior in Dementia
- Syndrome
- Sleep Wake Disorders
- Psychomotor Agitation
- Restless Legs Syndrome
- Parasomnias
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Purinergic Antagonists
- Purinergic Agents
- Purinergic P1 Receptor Antagonists
- Adenosine A2 Receptor Antagonists
- Istradefylline
Other Study ID Numbers
- 6002-US-201
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