Trial · NCT07040137
Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
NCT07040137, Phase 3, Active not recruiting, Kissei Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration. Trials, record NCT07040137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07040137
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
- NCT number
- NCT07040137
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 142 participants, estimated
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Conditions
- Spinocerebellar Degeneration
- Interventions
- KPS-0373, Placebo
- First posted
- 2025-06-27
- Last updated
- 2026-09-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in SARA total score at 24 weeks of treatment period | Up to 24 weeks | 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). |
| Secondary | Change from baseline in SARA total score | Up to 24 weeks | 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). |
| Secondary | Symptom Maintenance Ratio (Ratio of Improvement and Stability Cases) based on SARA total score | Up to 24 weeks | 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. |
| Secondary | Change from baseline in SARA individual scores | Up to 24 weeks | 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). |
| Secondary | Change from baseline in SF-8 | Up to 24 weeks | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07040137
GET https://conductscience.org/api/trials/v1/NCT07040137/registered