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Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

NCT ID: NCT00957203

Last Updated: 2012-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-03-31

Brief Summary

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Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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Parkinson's disease levodopa end of dose wearing off OFF time

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Istradefylline

Group Type EXPERIMENTAL

Istradefylline

Intervention Type DRUG

Oral istradefylline (KW-6002) 20 or 40 mg once daily

Interventions

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Istradefylline

Oral istradefylline (KW-6002) 20 or 40 mg once daily

Intervention Type DRUG

Other Intervention Names

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KW-6002

Eligibility Criteria

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Inclusion Criteria

1. Be willing and able to give written informed consent
2. Completion of the study 6002-009

Exclusion Criteria

1. Mini-mental status examination score of 23 or less
2. Less than 70% of compliance in the study 6002-009
3. Emergency deviation in the study 6002-009
4. Pregnant females
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Kyowa Kirin Co., Ltd.

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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6002-010

Identifier Type: -

Identifier Source: org_study_id