Status:
COMPLETED
Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome
Lead Sponsor:
Kyowa Kirin, Inc.
Collaborating Sponsors:
Kyowa Kirin Co., Ltd.
Conditions:
Sleep Disorder
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
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,...
Eligibility Criteria
Inclusion
- RLS that is mild to moderate in severity, non-nursing and non-pregnant if female, with an otherwise normal examination.
Exclusion
- Unable to stop other RLS medication, treatment with excluded medications, abnormal medical status.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00199446
Start Date
July 1 2005
End Date
October 1 2006
Last Update
April 25 2024
Active Locations (1)
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1
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540