Friedreich's ataxia
Conditions
Brief summary
Part 1: To evaluate the change in peak work during maximal exercise testing, Part 1: To evaluate the safety and tolerability of RTA 408, Part 2: To evaluate the change in the mFARS score at Week 48, Part 2: To evaluate the safety and tolerability of RTA 408
Detailed description
Part 1: To evaluate the change in the modified Friedreich’s ataxia rating scale (mFARS) score, Part 2: To evaluate the change in peak work during maximal exercise testing at Week 48, Part 2: To evaluate the Patient Global Impression of Change at Week 48, Part 2: To evaluate the Clinical Global Impression of Change at Week 48
Interventions
Sponsors
Reata Pharmaceuticals Inc., Reata Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: To evaluate the change in peak work during maximal exercise testing, Part 1: To evaluate the safety and tolerability of RTA 408, Part 2: To evaluate the change in the mFARS score at Week 48, Part 2: To evaluate the safety and tolerability of RTA 408 | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: To evaluate the change in the modified Friedreich’s ataxia rating scale (mFARS) score, Part 2: To evaluate the change in peak work during maximal exercise testing at Week 48, Part 2: To evaluate the Patient Global Impression of Change at Week 48, Part 2: To evaluate the Clinical Global Impression of Change at Week 48 | — |
Countries
Austria, Italy
Outcome results
None listed