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

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.
ClinicalTrials.gov Identifier: NCT01970098
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.

Condition or disease Intervention/treatment Phase
Spinocerebellar Degeneration Drug: KPS-0373, High dose Drug: KPS-0373, Low dose Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Completion Date : January 2015


Arms and Interventions

Arm Intervention/treatment
Experimental: KPS-0373 Drug: KPS-0373, High dose Drug: KPS-0373, Low dose
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. SARA (Scale for the Assessment and Rating of Ataxia) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. SF-8 (QOL) [ Time Frame: 24 weeks ]

Eligibility Criteria

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
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): NCT01970098


Locations
Japan
Tokyo and Other Japanese Cities, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
More Information

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01970098     History of Changes
Other Study ID Numbers: KPS1301
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Spinocerebellar degeneration (SCD)
Thyrotropin-Releasing Hormone (TRH)
Spinocerebellar Ataxia (SCA)
Cortical Cerebellar Atrophy (CCA)

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