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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01004016
First Posted: October 29, 2009
Last Update Posted: September 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kissei Pharmaceutical Co., Ltd.
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]
  • Upper and lower extremity function [ Time Frame: 4 weeks + 12 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01004016     History of Changes
Other Study ID Numbers: KPS1202
First Submitted: October 27, 2009
First Posted: October 29, 2009
Last Update Posted: September 28, 2010
Last Verified: September 2010

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

Additional relevant MeSH terms:
Spinocerebellar Ataxias
Cerebellar Ataxia
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
Dyskinesias
Neurologic Manifestations
Thyrotropin-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs


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