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A Long-Term 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: NCT01970124
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the long-term safety, efficacy, 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 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Primary Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: KPS-0373 Drug: KPS-0373, High dose
Drug: KPS-0373, Low dose


Outcome Measures
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Primary Outcome Measures :
  1. SARA (Scale for the Assessment and Rating of Ataxia) [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. SF-8 (QOL) [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Japanese SCD patients with ataxia

Exclusion Criteria:

  • Patients with secondary ataxia
  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Contacts and Locations
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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): NCT01970124


Locations
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Japan
Tokyo and Other Japanese Cities, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01970124    
Other Study ID Numbers: KPS1303
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)
Additional relevant MeSH terms:
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Spinocerebellar Degenerations
Spinocerebellar Ataxias
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
 Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cerebellar Ataxia
Ataxia
Dyskinesias
Neurologic Manifestations