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

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Abstract

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<0.01; baclofen: −8.3%, P<0.05), but only eperisone improved this parameter in the upper limbs (−7.8%, P<0.01 vs. −6.3%, P=NS). Both drugs reduced muscular tone from week 2. Only eperisone improved the joint range of motion (−32.5%, P<0.01 vs. −14.6%, P=NS). Both treatments reduced the 10-meter walking time (eperisone: −20.2%, P<0.01; baclofen: −24.0%, P<0.01); this effect was evident at week 2 with eperisone only. Both drugs improved reflexes. Eperisone and baclofen decreased the Hmax/Mmax amplitude ratio (eperisone: −30.0%, baclofen: −18.6%; P<0.01 for both). Eperisone increased the number of leg oscillations at the Wartenberg test (P<0.05) while baclofen increased the velocity of leg falling (P<0.01). For tolerability, no differences were observed between eperisone and baclofen in any parameters. Eperisone was judged as “good“ by a higher number of physicians and patients than baclofen. Eighteen adverse events, most of mild intensity, were reported with eperisone and 27 with baclofen.

Conclusion

Eperisone 300 mg/day and baclofen 60 mg/day, administered orally, are effective and well-tolerated drugs in the treatment of spastic palsy. However, eperisone might be associated with some additional clinical benefits when compared with baclofen.

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Authors and Affiliations

  1. IRCCS Ospedale Maggiore Policlinico, Institute of Clinical Neurology, University of Milan, Via F. Sforza, 35, 20122, Milan, Italy

    N. Bresolin

  2. Neurophysiopathology Unit, IRCCS “E. Medea”, Bosisio Parini (LC), Italy

    C. Zucca

  3. Medical Department, Eisai Srl, via dell’Unione Europea, San Donato Milanese, Italy

    A. Pecori

Authors
  1. N. Bresolin
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  2. C. Zucca
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  3. A. Pecori
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Correspondence to N. Bresolin.

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Bresolin, N., Zucca, C. & Pecori, A. Efficacy and tolerability of eperisone and baclofen in spastic palsy: a double-blind randomized trial. Adv Therapy 26, 563–573 (2009). https://doi.org/10.1007/s12325-009-0031-8

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