Efficacy and Safety of Leriglitazone in Patients With Friedreich Ataxia: A Phase 2 Double-Blind, Randomized Controlled Trial (FRAMES).

Massimo PandolfoKathrin ReetzAlejandra DarlingFrancisco Javier Rodriguez de RiveraPierre-Gilles HenryJames JoersChristophe LengletIsaac AdanyeguhDinesh DeelchandFanny MochelFrançoise PoussetSílvia PascualDelphine Van den EedeItziar Martin-UgarteAnna Vilà-BrauAdriana MantillaMaría PascualMarc MartinellUwe MeyaAlexandra Durr

Published in: Neurology. Genetics (2022)

This study provides Class I evidence that individualized dosing of leriglitazone, compared with placebo, is not associated with changes in spinal cord area in patients with FRDA.

Keyphrases

randomized controlled trial
spinal cord
double blind
study protocol
placebo controlled
clinical trial
spinal cord injury
phase iii
neuropathic pain
phase ii