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Trial record 29 of 121 for:    "spinocerebellar ataxia type 2" OR "Spinocerebellar Ataxias"

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

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ClinicalTrials.gov Identifier: NCT02889302
Recruitment Status : Active, not recruiting
First Posted : September 5, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

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 Type : Interventional  (Clinical Trial)
Estimated Primary Completion Date : November 2018


Arm Intervention/treatment
Experimental: KPS-0373 Drug: KPS-0373
Placebo Comparator: Placebo Drug: Placebo



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 ]


Information from the National Library of Medicine

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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 mild to moderate ataxia

Exclusion Criteria:

  • Patients with secondary ataxia
  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

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
Japan
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02889302     History of Changes
Other Study ID Numbers: KPS1305
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
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