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An Additional 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: NCT02889302
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : December 14, 2018
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 investigate the superiority of KPS-0373 to placebo, and evaluate the safety of KPS-0373 in SCD patients.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Additional Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: KPS-0373 Drug: KPS-0373
24 weeks
Placebo Comparator: Placebo Drug: Placebo
24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. SARA (Scale for the Assessment and Rating of Ataxia) [ Time Frame: 24 weeks ]
    The change in the SARA total score at the time of final evaluation


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

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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
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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): NCT02889302


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
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Study Director: Nobuo Kanai
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02889302    
Other Study ID Numbers: KPS1305
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
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