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

April 23, 2024 updated by: Kyowa Kirin, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Kyowa Pharmaceutical Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in an RLS rating scale score at endpoint (6 weeks of treatment or early discontinuation).

Secondary Outcome Measures

Outcome Measure
Safety
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin, Inc.

Collaborators

Kyowa Kirin Co., Ltd.

Investigators

  • Study Director: James Williams, MD, Kyowa Kirin, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6002-US-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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