PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS MedDRA version: 9.1 Level: SOC Classification code 10029205
Conditions
Interventions
Trade Name: MYONAL*30CPR RIV 100MG
Pharmaceutical Form: Tablet
INN or Proposed INN: EPERISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: LIOR
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed