Status:
COMPLETED
Safety and Efficacy of Etravirine in Friedreich Ataxia Patients
Lead Sponsor:
IRCCS Eugenio Medea
Collaborating Sponsors:
University of Rome Tor Vergata
Conditions:
Friedreich Ataxia
Eligibility:
All Genders
10-40 years
Phase:
PHASE2
Brief Summary
A drug repositioning effort provided evidence supporting the possible use of Etravirine, a drug approved for the treatment of HIV infections in patients starting from 2 years of age, as a treatment fo...
Detailed Description
Friedreich ataxia is a rare progressive neurodegenerative disease presenting in childhood or late adolescence for which no treatment is currently available. The disease is caused by the defective synt...
Eligibility Criteria
Inclusion
- Molecularly defined FA diagnosis (at least one expanded FXN allele),
- ability to complete maximal exercise testing (being able to ride a recumbent exercise ergometer at 60 rpm with no added resistance for at least 3 minutes),
- willingness to participate, as shown by the signed consent form.
Exclusion
- Known intolerance to any of the components of the drug preparation.
- Ongoing treatment with Etravirine or other experimental therapeutics under study for FA (e.g. IFNy, erythropoietin, nicotinamide, etc.).
- Previous treatment, if any, should have been stopped at least 4 weeks before study entry.
- Severe medical condition likely to interfere with drug absorbance and distribution (liver or kidney failure, severe metabolic unbalance), significant cardiac disease
Key Trial Info
Start Date :
September 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04273165
Start Date
September 17 2020
End Date
January 17 2023
Last Update
December 4 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS Medea Scientific Institute, Pieve di Soligo Research Centre
Pieve di Soligo, TV, Italy, 31953