Effects of Acetyl-Leucine on Spinocerebellar ataxia
- Conditions
- Spinocerebellar Ataxia.Hereditary ataxia
- Registration Number
- IRCT20210413050958N7
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 4
Age above 6 years
Patients with a definitive diagnosis of Spinocerebellar ataxia
Having clinical signs
If the patient is taking any medication, he/she should maintain a constant dose/not change his/her treatment during the study period.
Have not taken any forbidden drugs including any variant of N-acetyl-DL-leucine, aminopyridines, Riluzole, gabapentin, Varenicline, Chlorzoxazone, sulfasalazine, Rosuvastatin at least 4 weeks before visit 1 and throughout the duration of the study
Signed informed consent form by the subjects or their parents after explaining the study objectives by the research team
Patient satisfaction
Having chronic diarrhea, visual loss, malignancies or insulin-dependent diabetes mellitus
History of hypersensitivity to the N-Acetyl-Leucine
Having severe vision or hearing impairment
Having arthritis or other musculoskeletal disorders
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Scale for Assessment and Rating of Ataxia (SARA) score. Timepoint: Before the intervention and 4 weeks after taking supplement or placebo in every study stage. Method of measurement: Scale for Assessment and Rating of Ataxia (SARA) Questionnaire.;Spinocerebellar Ataxia Functional Index (SCAFI). Timepoint: Before the intervention and 4 weeks after taking supplement or placebo in every study stage. Method of measurement: Spinocerebellar Ataxia Functional 8-m walking time (SCAFI-8MWT) and Spinocerebellar Ataxia Functional 9-hole peg test (SCAFI-9HPT).
- Secondary Outcome Measures
Name Time Method