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

NCT00199446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-04-25

No results posted yet for this study

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.

Conditions

  • Sleep Disorder
  • Restless Legs Syndrome

Interventions

DRUG

Istradefylline (KW-6002)

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    collaborator INDUSTRY

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Principal Investigators

  • James Williams, MD · Kyowa Kirin, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2006-08-31
Completion
2006-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00199446 on ClinicalTrials.gov