An Extension Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

NCT ID: NCT01970111

Last Updated: 2016-04-18

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

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients.

Detailed Description

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Conditions

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Spinocerebellar Degeneration

Study Groups

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KPS-0373

Group Type EXPERIMENTAL

KPS-0373, High dose

Intervention Type DRUG

KPS-0373, Low dose

Intervention Type DRUG

Interventions

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KPS-0373, High dose

Intervention Type DRUG

KPS-0373, Low dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese SCD patients with mild to moderate ataxia (Completion of the KPS1301 study)

Exclusion Criteria

* Less than 75% of compliance in KPS1301 study
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tokyo and Other Japanese Cities, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KPS1302

Identifier Type: -

Identifier Source: org_study_id

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