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

NCT ID: NCT00199381

Last Updated: 2024-05-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-10-31

Brief Summary

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This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

Detailed Description

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Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.

Conditions

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Parkinson's Disease

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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Single Arm

Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.

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

* Completion of study 6002-INT-001
* Not of childbearing potential

Exclusion Criteria

* Cancer within 5 years of enrollment
* ALT/AST levels \> 2.5 times ULN
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Kyowa Kirin, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Sussman, MD

Role: STUDY_DIRECTOR

Kyowa Kirin, Inc.

Locations

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Kyowa Pharmaceutical Inc.

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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6002-US-025

Identifier Type: -

Identifier Source: org_study_id

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