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

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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

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


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: VLDLR-associated cerebellar hypoplasia Autosomal recessive cerebellar ataxia type 1 Infantile-onset spinocerebellar ataxia Spinocerebellar ataxia type 1 Spinocerebellar ataxia type 2 Spinocerebellar ataxia type 3 Spinocerebellar ataxia type 6

Genetic and Rare Diseases Information Center resources: Spinocerebellar Ataxia

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

SARA (Scale for the Assessment and Rating of Ataxia) [ Time Frame: 52 weeks ]

Secondary Outcome Measures :

SF-8 (QOL) [ Time Frame: 52 weeks ]

Eligibility Criteria

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 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): NCT01970124

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:	NCT01970124 History of Changes
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:


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 Thyrotropin-Releasing Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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