JPRN-jRCT2031200135CompletedPhase 2
A Placebo-Controlled, Double-Blind, Randomized, Group-Controlled Trial Evaluating the Efficacy and Safety of AJA030 in Spinocerebellar Degeneration.
Onodera Osamu0 sites40 target enrollmentStarted: September 30, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1) Patients with genetically diagnosed autosomal dominant hereditary spinocerebellar degeneration (SCA6). Note 1)
- •2) Patients aged 20 years or older at the time of informed consent.
- •3) Patients who scored 1 or more In SARA(Scale for the Assessment and Rating of Ataxia) gait scores in the pre-enrollment test and had a SARA sum score of 10 or more.
- •4) Patients who are able to walk 10m or more with or without assistive devices in the pre-enrollment test.
- •5) Patients for whom written informed consent is obtained from the individual for participation in the clinical trial.
- •Note 1) Genetic diagnosis of the patient is not indispensable, when the disease type is confirmed by the genetic diagnosis in the family.
Exclusion Criteria
- •1) Patients with gait or balance disorders due to medical conditions other than spinocerebellar degeneration (stroke, brain tumor, head injury, multiple sclerosis, hypothyroidism, alcoholic ataxia, joint disease, others)
- •2) Patients with arginase deficiency (which exacerbates argininemia), patients with lysinuric protein intolerance who have a greater degree of inhibition of arginine absorption (which causes diarrhea with the use of arginine preparations)
- •3) Patients with dementia (MMSE<=23), mental illness (psychosis, manic-depressive illness, depression without treatment [Beck Depression Inventory score>=21]), or a history of suicidal attempt.
- •4) Patients with complications that are considered inappropriate for participation in the study, such as serious heart disease, liver disease, kidney disease, or hematologic disease.
- •5) Pregnant or possibly pregnant patients and breastfeeding patients.
- •6) Patients who are unable to consent to use effective contraceptive methods during the study participation period.
- •7) Patients who took oral preparations that were judged by the principal investigator or the subinvestigator to be supplements containing algin U or L-arginine as the main ingredient within 30 days prior to the date of informed consent.
- •8) Patients who participated in another clinical trial within 6 months before the date of obtaining informed consent.
- •9) Patients who are considered inappropriate to participate in the study by the principal investigator or the subinvestigator.
Investigators
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