Overview
A Clinical Study to Evaluate the Effect of MIN-102 on the Progression of Friedreich's Ataxia in Male and Female Patients
Status:
Completed
Completed
Trial end date:
2020-09-14
2020-09-14
Target enrollment:
0
0
Participant gender:
All
All
Summary
Randomized, double-blind, placebo-controlled study on the effects of MIN-102 on Biochemical, Imaging, neurophysiological, and clinical markers in patients with Friedreich's AtaxiaPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Minoryx Therapeutics, S.L.
Criteria
Inclusion Criteria:- Male and female subjects aged ≥12 and ≤60 years, inclusive, with a genetically
confirmed diagnose of Friedreich's Ataxia.
- Be able to walk > 10 meters with support (two special sticks, stroller or accompanying
person).
- Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) of < 25.
Exclusion Criteria:
- Age of onset of disease ≥25 years.
- Higher degree of cardiomyopathy assessed by echocardigram.
- Diabetes