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

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ClinicalTrials.gov Identifier: NCT01970111
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : April 18, 2016
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

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 Type : Interventional  (Clinical Trial)
Primary Completion Date : July 2015

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

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 ]

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

Inclusion Criteria:

  • Japanese SCD patients with mild to moderate ataxia (Completion of the KPS1301 study)

Exclusion Criteria:

  • Less than 75% of compliance in KPS1301 study

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): NCT01970111

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

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01970111     History of Changes
Other Study ID Numbers: KPS1302
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
Cerebellar Diseases
Cerebellar Ataxia
Spinocerebellar Ataxias
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurologic Manifestations
Thyrotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs