A Phase 3 interventional study of KPS-0373 and Placebo in Spinocerebellar Degeneration, sponsored by Kissei Pharmaceutical Co., Ltd.. Active, not recruiting at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Kissei Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study to evaluate the efficacy and safety of KPS-0373 given once daily after breakfast in 142 patients with spinocerebellar degeneration . This study consists of the 4-week screening period, 24-week treatment period, and 4-week follow-up period.
49 studies on the registry are indexed under Spinocerebellar Degenerations; 15 are open to participants now.
This study's planned enrollment of 142 is above the median of 45 across 36 interventional studies indexed under Spinocerebellar Degenerations.
Browse Spinocerebellar Degenerations studies →Kissei Pharmaceutical Co., Ltd. is the lead sponsor of 63 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One KPS-0373 2.4 mg tablet is orally administered once daily after breakfast.
Drug: KPS-0373
One placebo tablet is orally administered once daily after breakfast.
Drug: Placebo
Oral administration
Oral administration
Change from baseline in SARA total score at 24 weeks of treatment period
The SARA is a scale that assesses cerebellar ataxia. An evaluator observes the subject's ability to perform motor activities across in 8 individual items: ("gait: 0-8 points," "stance: 0-6 points," "sitting: 0-4 points," "speech disturbance: 0-6 points," "finger chase: 0-4 points," "nose-finger test: 0-4 points," "fast alternating hand movements: 0-4 points," and "heel-shin slide: 0-4 points." The total SARA score ranges from 0 (no ataxia) to 40 (severe ataxia).
Time frame: Up to 24 weeks
Change from baseline in SARA total score
The SARA is a scale that assesses cerebellar ataxia. An evaluator observes the subject's ability to perform motor activities across in 8 individual items: ("gait: 0-8 points," "stance: 0-6 points," "sitting: 0-4 points," "speech disturbance: 0-6 points," "finger chase: 0-4 points," "nose-finger test: 0-4 points," "fast alternating hand movements: 0-4 points," and "heel-shin slide: 0-4 points." The total SARA score ranges from 0 (no ataxia) to 40 (severe ataxia).
Time frame: Up to 24 weeks
Symptom Maintenance Ratio (Ratio of Improvement and Stability Cases) based on SARA total score
Subjects with the change in total SARA score from baseline of ≤ -1 point are defined as improved subjects, subjects with the change in total SARA score of \> -1 point and \< 1 point as unchanged subjects, and subjects with improvement and subjects with no change are defined as subjects maintaining symptoms.
Time frame: Up to 24 weeks
Change from baseline in SARA individual scores
The SARA is a scale that assesses cerebellar ataxia. An evaluator observes the subject's ability to perform motor activities across in 8 individual items: ("gait: 0-8 points," "stance: 0-6 points," "sitting: 0-4 points," "speech disturbance: 0-6 points," "finger chase: 0-4 points," "nose-finger test: 0-4 points," "fast alternating hand movements: 0-4 points," and "heel-shin slide: 0-4 points." The total SARA score ranges from 0 (no ataxia) to 40 (severe ataxia).
Time frame: Up to 24 weeks
Change from baseline in SF-8
SF-8 is a questionnaire that comprehensively measures health-related QOL. Subjects answer questions in the following 8 items on a scale of 5 or 6: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. A higher score indicates better health in that item.
Time frame: Up to 24 weeks
Plan to share: Yes — The Individual Patient Data (IPD) are available upon reasonable request and with permission of Kissei Pharmaceutical Co., Ltd. For a data sharing request for IPD, please contact Kissei Pharmaceutical at rinsyousiken@pharm.kissei.co.jp.
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Mar 2027, 19 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Rovatirelin
Spinocerebellar Degenerations →
Kissei Pharmaceutical Co., Ltd. →