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Efficacy and Tolerability of Eperisone in Patients with Spastic Palsy: a Cross-Over, Placebo-Controlled Dose-Ranging Trial

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Efficacy and Tolerability of Eperisone in Patients with Spastic Palsy: a Cross-Over, Placebo-Controlled Dose-Ranging Trial European Review for Medical and Pharmacological Sciences 2009; 13: 365-370 Efficacy and tolerability of eperisone in patients with spastic palsy: a cross-over, placebo-controlled dose-ranging trial N. BRESOLINA, C. ZUCCAB, A. PECORIC AInstitute of Clinical Neurology, University of Milan, I.R.C.C.S. Ospedale Maggiore Policlinico, Milan (Italy) BNeurophysiopathology Unit, IRCCS “E. Medea”, Bosisio Parini (LC) (Italy) CMedical Department Eisai Srl, San Donato Milanese, Milano (Italy) Abstract. – Background and Objectives: Introduction Central muscle relaxants are a clinical option in patients with spastic palsy. Eperisone is a cen- tral muscle relaxant used in several conditions, Spastic palsy is a clinical condition character- but its therapeutic potential in spastic palsy ized by a velocity-dependent increase of muscle needs to be verified. This dose-ranging trial tone due to “parapyramidal” disturbance of the compares two doses of eperisone in patients inhibitory afferents to the second motor neuron1. with spastic palsy associated to cerebral or spinal diseases. This condition may represent a major impedi- Patients and Methods: In this randomized, ment to a full functional recovery and social re- placebo-controlled, double-blind, three-way habilitation in patients with lesions of the pyra- cross-over study, patients (18-75 years) with midal system, which could follow different dis- spastic palsy received eperisone 150 mg/day, eases, as stroke or multiple sclerosis. eperisone 300 mg/day, or placebo for 8 weeks. Central muscle relaxants, such as baclofen, ti- Treatment periods lasted for 14 days. Objective zanidine, diazepam and dantrolene, represent an clinical parameters (intensity of spasticity and physiological reflexes) and functional parame- interesting clinical option in patients with spastic ters (walking capability, capability to climb palsy, since they reduce spasticity and improve stairs, rigidity) were measured. Tolerability was walking capabilities and subjective symptoms of also evaluated. spastic paralysis2. These drugs improve the Results: Eighteen patients were enrolled. The spasm by acting on the polysynaptic reflex mech- reduction in the intensity of spasticity versus anisms2. Noteworthy, spastic palsy patients re- the beginning of each treatment cycle was sig- nificant with eperisone 300 mg/day (p =0.004). quire a chronic administration of central muscle Similar findings were observed in the evaluation relaxants and therefore the tolerability profile of patellar reflex (p =0.01), while the other reflex- may represent a central issue in the choice of the es were not significantly different. Walking capa- optimal drug. The identification of the optimal bility was significantly improved with eperisone therapeutic strategy is also complicated by the 300 mg/day (p <0.05). No significant differences lack of quantitative tests, which could represent a were observed in the capability to climb stairs confounding factor in the evaluation of the effi- and in rigidity. A trend towards a reduction in 3 pain was noted with eperisone 300 mg/day ver- cacy of different central muscle relaxants . sus placebo. The incidence of adverse events Eperisone hydrochloride (eperisone), a central was similar in all groups. muscle relaxant has shown marked clinical ef- Discussion: Eperisone 300 mg/day might be fects in a number of conditions, such as cervical an effective and well-tolerated treatment for spondylosis, headache and low back pain4-7. It re- spastic palsy. Larger studies are required to fur- duces alpha- and gamma-efferent activities and ther characterize the efficacy of eperisone in this therapeutic area. inhibits spinal cord activities by acting on the spinal cord and supraspinal structures8,9. In Key Words: healthy volunteers, eperisone (150 and 300 Central muscle relaxants, Eperisone, Spastic palsy. mg/day) suppressed spontaneous contraction of muscle spindle, as well as static and dynamic re- Corresponding Author: Nereo Bresolin, MD; e-mail: nereo.bresolin unimi.it 365 N. Bresolin, C. Zucca, A. Pecori sponses to stretch9. In addition to its relaxant ef- No other anti-spastic drugs or muscle relax- fect, eperisone exerts a vasodilatatory activity, ants were allowed during the study. Sedatives thus increasing muscle blood flow10,11 and is as- were also not allowed, since they could interfere sociated to antinociceptive effects by inhibiting with the effects of eperisone. Other medications the release of P substance12. Importantly, were allowed, but no variations of dosage were eperisone has not demonstrated sedative effects, permitted during the study period. differing from other muscle relaxant agents13,14. On this basis, eperisone could potentially rep- Evaluations and Study Endpoints resent an interesting therapeutic strategy in the After a baseline visit, in which the eligibility treatment of spastic palsy. The aim of this pre- into the study was evaluated, the patients were liminarily cross-over, placebo controlled dose- monitored at the start and at the end of each finding trial is to compare the efficacy and tolera- treatment period. At each visit, the efficacy was bility of eperisone at two different doses (150 evaluated via objective clinical parameters and and 300 mg/day) in patients with spastic palsy functional parameters. Objective clinical parame- associated to cerebral or spinal diseases. ters included: (1) the intensity of spasticity (mea- sured with a semiquantitative scale: 1 = mild, 2 = moderate, 3 = severe, 4 = most severe); (2) physi- ological reflexes (patellar reflex and Achilles ten- Patients and Methods don reflex, measured with a semiquantitative scale: 1 = normal, 2 = slightly increased, 3 = Study Design moderately increased, 4 = severely increased); This was a randomized, placebo-controlled, (3) pathological reflexes (foot clonus reflex and double-blind; three-way cross-over study con- plantar reflex; 1 = normal, 2 = slightly increased, ducted in one Italian university clinic specialized 3 = moderately increased, 4 = severely in- in the treatment of neurological diseases, i.e. creased). Neurology Clinic Institute, University of Milan, Functional parameters included: (a) walking Milan, Italy). capability (measured with a semiquantitative In- and outpatients with an age between 18 scale: 1 = normal, 2 = moderately difficult, 3 = and 75 years, affected by spastic palsy associated difficult, 4 = most difficult), (b) capability to to cerebral or spinal disease were eligible in this climb stairs (1 = normal, 2 = moderately diffi- study. Exclusion criteria were the following: se- cult, 3 = difficult, 4 = most difficult); (c) rigidity vere liver or kidney insufficiency, severe sys- while resting and during exercise (1 = absent, 2 = temic or functional diseases (cancer, psychosis), mild, 3 = moderate; 4 = severe), and pain (1 = pregnancy, hypersensibility to eperisone. More- absent, 2 = mild, 3 = moderate; 4 = severe). Tol- over, the presence of any other confounding fac- erability was evaluated by monitoring adverse tor (e.g. rehabilitation therapy) was considered as events and their potential correlation to the treat- an exclusion criterion according to the investiga- ment, as well as by measuring laboratory para- tors’ judgment. The study was conducted in ac- meters and vital signs at the study entry and at cordance to the declaration of Helsinki. All pa- the study end. tients signed an informed consent and the Ethical Committees of each centre approved the study Statistical Analysis design. All data were analyzed by descriptive statis- The study lasted 8 weeks. Each enrolled pa- tics and are reported as mean ± SD. Baseline tient received three consecutive treatment cycles: characteristics of the patients randomized to eperisone 150 mg/day, eperisone 300 mg/day, or different sequences of treatment cycles were placebo. The different treatment cycles were ad- compared by the Mann-Whitney (not-paramet- ministered in three different orders, according to ric data) or t-test for independent data (para- a pre-defined randomized sequence. Since the metric data). only available formulation of eperisone was a 50 Efficacy data were compared by Friedman mg tablet, the patients took two tablets (active ANOVA, with a Wilcoxon post-hoc test (continu- drug or placebo) three times a day. Every treat- ous variables) or by a chi-square test (categorical ment period lasted 14 days; before entering the variables). Laboratory parameters were com- following period, the patients underwent a 7-day pared by Mc Neumar test. A p value <0.05 was washout (administration of placebo). considered as statistically significant. 366 Efficacy of two doses of eperisone in spastic palsy Results associated to a significant reduction in the score of patellar reflex. Statistical analysis disclosed a Patient Characteristics trend towards a difference between eperisone 300 In total, 18 patients were enrolled in the study. mg/day and placebo (p <0.1). Achilles tendon re- Baseline characteristics are reported in Table I. flex was not significantly reduced in association Eleven (61.1%) subjects were male; the mean to eperisone or placebo. However, the decrease in age of the patients was 48.8 years (range: 19-67 the semiquantitative score observed with years). Paraparesis was diagnosed in 13 patients, eperisone 300 mg/day almost reached the statisti- with 2 cases of hemiparesis and 3 of quadripare- cal significance (p =0.06) (Table II). No differ- sis. Mean duration of the disease was 103.7 ences were observed between different eperisone
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