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

NCT ID: NCT02889302

Last Updated: 2018-12-14

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

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-15

Study Completion Date

2018-03-31

Brief Summary

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The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety of KPS-0373 in SCD patients.

Detailed Description

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Conditions

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Spinocerebellar Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KPS-0373

Group Type EXPERIMENTAL

KPS-0373

Intervention Type DRUG

24 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

24 weeks

Interventions

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KPS-0373

24 weeks

Intervention Type DRUG

Placebo

24 weeks

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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nobuo Kanai

Role: STUDY_DIRECTOR

Locations

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Multiple Locations, , Japan

Site Status

Countries

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Japan

References

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Nishizawa M, Onodera O, Hirakawa A, Shimizu Y, Yamada M; Rovatirelin Study Group. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials. J Neurol Neurosurg Psychiatry. 2020 Mar;91(3):254-262. doi: 10.1136/jnnp-2019-322168. Epub 2020 Jan 14.

Reference Type DERIVED
PMID: 31937586 (View on PubMed)

Other Identifiers

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KPS1305

Identifier Type: -

Identifier Source: org_study_id