Efficacy and tolerability of eperisone and baclofen in spastic palsy: A double-blind randomized trial

Introduction: Few trials have compared different central muscle relaxants in the treatment of spastic palsy. This head-to-head phase 3 trial compares oral eperisone, a central muscle relaxant with a promising activity in spasticity therapy, and oral baclofen. Methods: Patients (>18 years) with moderate to severe spastic palsy were eligible in this double-blind, randomized study; they received eperisone 300 mg/ day or baclofen 60 mg/day for 6 weeks. The efficacy evaluations included: functional analysis (Pedersen's scale, muscular tone, joint range of motion, 10-meter walking time); physiological and pathological reflexes; and electromyography (Hmax/Mmax amplitude ratio and the Wartenberg test). Physicians and patients globally assessed treatment efficacy. Results: Both eperisone (n=40) and baclofen (n=40) significantly improved functionality of lower limbs versus baseline (eperisone: -9.1%, P