Efficacy and safety in the treatment of fibromyalgia with eperisone hydrochloride

INTERVENTION: Trade Name: EXPOSE*30CPR RIV 100MG Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: EPERISONE HYDROCHLORIDE CAS Number: 56839‐43‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Fibromialgia ; MedDRA version: 20.0 Level: PT Classification code 10048439 Term: Fibromyalgia System Organ Class: 10028395 ‐ Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of eperisone hydrochloride as a therapy in patients with fibromyalgia. Primary end point(s): Evaluation of improvement in fibromyalgia syndrome based on the visual analogue scale (VAS), comparing the two treatment groups at week 12 compared to baseline. Secondary Objective: To evaluate the safety and tolerability of eperisone hydrochloride in patients with fibromyalgia. Timepoint(s) of evaluation of this end point: 12 weeks. SECONDARY OUTCOME: Secondary end point(s): Evaluation of fibromyalgia syndrome based on the FIQ, FAS and Tender Points questionnaires, comparing the two treatment groups. Timepoint(s) of evaluation of this end point: 0, 4, 8, 12 weeks. INCLUSION CRITERIA: 1. Patients of both sexes aged 18 years or older. 2. Signed informed consent. 3. Diagnosis of FM based on the ACR 1990 classification criteria, which require the presence of widespread musculoskeletal pain for at least three months and positivity of at least 11 of the 18 tender points. 4. Patients undergoing treatment with permitted non-pharmacological therapies, stable for at least 4 weeks before V1 and maintained throughout the study period. Are the trial subjects under 18? No Number of subjects for this age range: F.1.2 Adults (18-64 years) Yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) Yes F.1.3.1 Number of subjects for this age range 20