A pilot, prospective, randomized, open, blinded end point, phase II study of tolerability and efficacy of Eperisone in Amyotrophic Lateral Sclerosis - EPERISONE AND ALS

Conditions: PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS
MedDRA version: 9.1Level: SOCClassification code 10029205

Registration Number: EUCTR2010-020257-13-IT

Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

In order to be included in this study, patients must meet all of the following criteria: 1. Can provide signed/dated Informed Consent; 2. Are a male or female patient 18-75 years of age; 3. Diagnosis of Amyotrophic Lateral Sclerosis according to EI Escorial Revised Criteria 4. Life expectancy of at least 6 months
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients are excluded from this study if they meet any of the following criteria: 1. Are unable or unwilling to understand study assessment or to cooperate with the study procedures as determined by the investigator 2. any contraindication to the use of eperisone 3. diagnosis of other neurological disease in addition to ALS 4. female subjects pregnant or lactating or plan to become pregnant during the course of the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The two main objectives of the project to assess safety and tolerability of eperisone administration in ALS patients;;Secondary Objective: to assess the efficacy of eperisone for treatment of spasticity in ALS patients;Primary end point(s): The primary outcome measure are: 1) the number of therapeutic failures (treatment stops for ineffectiveness and/or AEs); 2) improvement of spasticity at three months or greater as measured by Ashworth spasticity score.

Secondary Outcome Measures