Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KPS-0373 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KPS-0373 | Drug | 24 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| SARA (Scale for the Assessment and Rating of Ataxia) | The change in the SARA total score at the time of final evaluation | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SF-8(QOL) | 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nobuo Kanai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31937586 | Derived | Nishizawa M, Onodera O, Hirakawa A, Shimizu Y, Yamada M; Rovatirelin Study Group. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials. J Neurol Neurosurg Psychiatry. 2020 Mar;91(3):254-262. doi: 10.1136/jnnp-2019-322168. Epub 2020 Jan 14. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013132 | Spinocerebellar Degenerations |
| ID | Term |
|---|---|
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
24 weeks |
|
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |