Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01004016
First received: October 27, 2009
Last updated: September 27, 2010
Last verified: September 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004016

Locations
Japan
Japan
Japan, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Yasuhiro Omori Clinical Development Department, Kissei Pharmaceutical Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov 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)
SCD

Additional relevant MeSH terms:
Spinocerebellar Degenerations
Spinocerebellar Ataxias
Cerebellar Diseases
Cerebellar Ataxia
Ataxia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
 Neurodegenerative Diseases
Genetic Diseases, Inborn
Dyskinesias
Neurologic Manifestations
Thyrotropin-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013