NCT00199446

CompletedPhase 2

Study of Istradefylline (KW-6002) for the Treatment of Restl...

Kyowa Kirin, Inc.Source

Compare

Other study identifiers

Sponsor study identifier

6002-US-201

Study Type

interventional

Reported enrollment (type unavailable)

160

Locations

1 country

Sites

1

Timeline

Study Start

July 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2006

Actual (reported)

Study Completion

October 2006

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 160 participants
Study completion date: October 2006
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 20, 2005
Actual (reported)
Primary Completion
August 2006
Actual (reported)
Study Completion
October 2006
Actual (reported)

Last Updated: April 25, 2024
Status Verified: April 2024
Last Update Submitted: April 23, 2024

Conditions

Sleep Disorder Restless Legs Syndrome

Keywords

Sleep -Sleep DisorderSleep- Restless Legs SyndromeClinical Trial

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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.
Safety

Interventions

Istradefylline (KW-6002)Drug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

RLS that is mild to moderate in severity, non-nursing and non-pregnant if female, with an otherwise normal examination.

You may not qualify if:

Sponsors & Collaborators

Kyowa Kirin Co., Ltd.
Industrycollaborator
Kyowa Kirin, Inc.
Industrylead

Study Sites (1)

Kyowa Pharmaceutical Inc.

Princeton, New Jersey, 08540, United States

MeSH Terms

Conditions

Sleep Wake DisordersRestless Legs Syndrome

Interventions

istradefylline

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomniasParasomnias

Study Officials

James Williams, MD
Kyowa Kirin, Inc.
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

July 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2006

Actual (reported)

Completed

NCT00250393

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

Phase 2Completed

NCT00455507

A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Phase 2Completed

NCT00199420

A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa

Phase 3Completed

NCT00199407

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Phase 3Completed

NCT00199381

An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001

Phase 3Terminated

NCT00685815

Intravenous Iron Metabolism in Restless Legs Syndrome

Phase 2Completed

Unable to stop other RLS medication, treatment with excluded medications, abnormal medical status.

Contact the study team to confirm eligibility.

Study Completion

October 2006

Actual (reported)

Last Updated

April 25, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00199446
Data provider: ClinicalTrials.gov
Source updated: 2024-04-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:17 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations