Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome
|ClinicalTrials.gov Identifier: NCT00199446|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorder Restless Legs Syndrome||Drug: Istradefylline (KW-6002)||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|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|
- 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.
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|
|Study Director:||James Williams, MD||Kyowa Kirin Pharmaceutical Development, Inc.|