Spinocerebellar Degeneration
Conditions
Keywords
Spinocerebellar degeneration, Thyrotropin-Releasing Hormone (TRH), SCD
Brief summary
To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD
Interventions
DRUGKPS-0373
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* SCD with mild to moderate ataxia
Exclusion criteria
* Patients with secondary ataxia * Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression | 12 weeks |
Countries
Japan
Outcome results
None listed