Extended Long-Term Safety Study of KW-6500

NCT ID: NCT01063621

Last Updated: 2017-03-15

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-03-31

Brief Summary

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This is a extended long-term safety study in Parkinson's disease patients who have motor response complications on levodopa therapy and completed 12 weeks administrations of KW-6500 in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of KW-6500 are evaluated.

Detailed Description

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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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KW-6500

Group Type EXPERIMENTAL

KW-6500

Intervention Type DRUG

Subcutaneous injection of 1 to 6 mg for the OFF state during 52 weeks

Interventions

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KW-6500

Subcutaneous injection of 1 to 6 mg for the OFF state during 52 weeks

Intervention Type DRUG

Other Intervention Names

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Apomorphine hydroshloride (USAN)

Eligibility Criteria

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Inclusion Criteria

* Patients who have given written informed consent
* Patients who have completed the 6500-004 study
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

Locations

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Tōon, Ehime, Japan

Site Status

Countries

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Japan

Other Identifiers

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6500-005

Identifier Type: -

Identifier Source: org_study_id

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