Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome

NCT ID: NCT00199446

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2006-10-31

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.

Conditions

Sleep Disorder; Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Istradefylline (KW-6002)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Kyowa Kirin, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Williams, MD

Role: STUDY_DIRECTOR

Kyowa Kirin, Inc.

Locations

Kyowa Pharmaceutical Inc.

Princeton, New Jersey, United States

Countries

United States

Other Identifiers

6002-US-201

Identifier Type: -

Identifier Source: org_study_id