Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199446
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2005-09-13
Brief Title:
Study of Istradefylline KW-6002 for the Treatment of Restless Legs Syndrome
Sponsor:
Kyowa Kirin Inc
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
A Phase 2 Double-blind Placebo-controlled Randomized Parallel-Group Multicenter Study to Evaluate the Efficacy and Safety of 40mgDay KW-6002 Istradefylline in Subjects With Restless Legs Syndrome
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None