A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
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ClinicalTrials.gov Identifier: NCT01004016 |
Recruitment Status :
Completed
First Posted : October 29, 2009
Last Update Posted : September 28, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinocerebellar Degeneration | Drug: KPS-0373 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Drug: Placebo |
Experimental: KPS-0373 |
Drug: KPS-0373 |
- Scale for Assessment and Rating of Ataxia (SARA) [ Time Frame: 4 weeks + 12 weeks ]
- Upper and lower extremity function [ Time Frame: 4 weeks + 12 weeks ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01004016
Japan | |
Japan | |
Japan, Japan |
Study Director: | Yasuhiro Omori | Clinical Development Department, Kissei Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01004016 |
Other Study ID Numbers: |
KPS1202 |
First Posted: | October 29, 2009 Key Record Dates |
Last Update Posted: | September 28, 2010 |
Last Verified: | September 2010 |
Spinocerebellar degeneration Thyrotropin-Releasing Hormone (TRH) SCD |
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 |