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A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

NCT ID: NCT01384435

Last Updated: 2012-12-03

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

200 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).

Detailed Description

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Conditions

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SCD

Keywords

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Spinocerebellar degeneration (SCD) Thyrotropin-Releasing Hormone (TRH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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KPS-0373, lowest dose

Group Type EXPERIMENTAL

KPS-0373

Intervention Type DRUG

KPS-0373, 2nd lowest dose

Group Type EXPERIMENTAL

KPS-0373

Intervention Type DRUG

KPS-0373, 2nd highest dose

Group Type EXPERIMENTAL

KPS-0373

Intervention Type DRUG

KPS-0373, highest dose

Group Type EXPERIMENTAL

KPS-0373

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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KPS-0373

Intervention Type DRUG

KPS-0373

Intervention Type DRUG

KPS-0373

Intervention Type DRUG

KPS-0373

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese SCD patients 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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Katsumi Hontani

Role: STUDY_DIRECTOR

Clinical Research Dept.

Locations

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Japan

Tokyo and Other Japanese City, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KPS1203

Identifier Type: -

Identifier Source: org_study_id