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
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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) |
Actual Primary Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: KPS-0373 |
Drug: KPS-0373, High dose Drug: KPS-0373, Low dose |
- SARA (Scale for the Assessment and Rating of Ataxia) [ Time Frame: 52 weeks ]
- SF-8 (QOL) [ Time Frame: 52 weeks ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
- Japanese SCD patients with ataxia
Exclusion Criteria:
- Patients with secondary ataxia
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

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
Japan | |
Tokyo and Other Japanese Cities, Japan |
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 |
Spinocerebellar degeneration (SCD) Thyrotropin-Releasing Hormone (TRH) Spinocerebellar Ataxia (SCA) |
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 |