Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
- Change from baseline in an RLS rating scale score at endpoint (6 weeks of treatment or early discontinuation).
- 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 |
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 |
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| United States, New Jersey | |
| Kyowa Pharmaceutical Inc. | |
| Princeton, New Jersey, United States, 08540 | |
| Study Director: | James Williams, MD | Kyowa Hakko Kirin Pharma, Inc. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00199446 History of Changes |
| Other Study ID Numbers: | 6002-US-201 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
|
Sleep -Sleep Disorder Sleep- Restless Legs Syndrome Clinical Trial |
Additional relevant MeSH terms:
|
Restless Legs Syndrome Sleep Disorders Parasomnias Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Nervous System Diseases Mental Disorders Neurologic Manifestations Signs and Symptoms Dyskinesias |
Psychomotor Disorders Neurobehavioral Manifestations Istradefylline Adenosine A2 Receptor Antagonists Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013