Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
ConditionSpinocerebellar Degeneration
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKissei Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Japanese SCD patients with mild to moderate ataxia
Disqualifiers
Patients with secondary ataxia
Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Trial design
Design model
Parallel
Treatments tested in this trial
KPS-0373
DrugOral administration
Placebo
DrugOral administration
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: KPS-0373 groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Research SiteRecruiting Multiple Locations
Japan
JapanSponsors and contacts
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Source ClinicalTrials.gov