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

This study has been completed.
Information provided by:
Kissei Pharmaceutical Co., Ltd. Identifier:
First received: October 27, 2009
Last updated: September 27, 2010
Last verified: September 2010
To evaluate the efficacy and safety of KPS-0373 in patients with SCD.

Condition Intervention Phase
Spinocerebellar Degeneration
Drug: KPS-0373
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD

Resource links provided by NLM:

Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Scale for Assessment and Rating of Ataxia (SARA) [ Time Frame: 4 weeks + 12 weeks ] [ Designated as safety issue: No ]
  • Upper and lower extremity function [ Time Frame: 4 weeks + 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: KPS-0373 Drug: KPS-0373


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01004016

Japan, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Study Director: Yasuhiro Omori Clinical Development Department, Kissei Pharmaceutical Co., Ltd.
  More Information Identifier: NCT01004016     History of Changes
Other Study ID Numbers: KPS1202 
Study First Received: October 27, 2009
Last Updated: September 27, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Spinocerebellar degeneration
Thyrotropin-Releasing Hormone (TRH)

Additional relevant MeSH terms:
Spinocerebellar Ataxias
Cerebellar Ataxia
Spinocerebellar Degenerations
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurologic Manifestations
Thyrotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on October 21, 2016