Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

NCT ID: NCT00863538

Last Updated: 2010-02-03

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

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD

Detailed Description

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Conditions

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Spinocerebellar Degeneration

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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1

Group Type EXPERIMENTAL

KPS-0373

Intervention Type DRUG

Interventions

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KPS-0373

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* SCD with mild to moderate ataxia

Exclusion Criteria

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
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

Principal Investigators

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Yasuhiro Omori

Role: STUDY_DIRECTOR

Kissei Pharmaceutical Co., Ltd.

Locations

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Japan

Hokkaido Region, , Japan

Site Status

Japan

Kansai Region, , Japan

Site Status

Japan

Kanto Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KPS1201

Identifier Type: -

Identifier Source: org_study_id

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