NCT00199446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

September 13, 2005

Last Update Submit

April 23, 2024

Conditions

Sleep DisorderRestless 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:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyowa Pharmaceutical Inc.

Princeton, New Jersey, 08540, United States

Location

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 1, 2005

Primary Completion

August 1, 2006

Study Completion

October 1, 2006

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

US(1)