Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Restless Leg Syndrome, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/14/2016 |
| Start Date: | July 2005 |
| End Date: | October 2006 |
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
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.
40 mg per day of istradefylline (KW6002) in patients with Restless Legs Syndrome.
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.
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.
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.
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