Amiotrophic Lateral Sclerosis MedDRA version: 6.1 Level: PT Classification code 10002026
Conditions
Interventions
Trade Name: EPREX IV SC 1FL 1ML 40000 UI
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Erythropoietin
CAS Number: 113427-24-0
Concentration unit: IU international unit(s)
Concentrati
Sponsors
ISTITUTO NEUROLOGICO CARLO BESTA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Caucasian male or female outpatients - aged 18 to 75 years inclusive - diagnosis of probable or definite ALS according to the El Escorial revised criteria Brooks et al., 2000 - first symptoms of ALS by no more than 2 years - in treatment with steady regimen of Riluzole and Vitamin E by at least 3 months, and desiring its continuation - FVC 75 of predicted - no conditions known to be contraindications to the use of EPO -written informed consent 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: - subjects who underwent tracheostomy - subjects with signs of conduction blocks of motor nerves, sensory nerves or both on nerve conduction study - subjects with clinical signs of dementia - history of myocardial infarction or thrombotic vascular events such as stroke, pulmonary emboli, deep vein thrombosis, TIA - clinically evident cardiac disease ischemic heart disease or congestive heart failure - uncontrolled hypertension - active malignancy - polycytemia - myeloproloferative disorders - hypercoagulabily disorders - porphyria - known hypersensitivity to human albumin - pregnant and lactating women - subjects who received an experimental drug or have participated in a clinical trial within 3 months prior to screening - employees of the Investigator or study centre with direct involvement in the study or in other sudies under the direction of the Investgator or study center
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if the addition of EPO to the conventional therapy can improve the therapeutic outcome in patients affected by ALS. Safety will be assessed for all subjects, for the entire duration of the study.;Secondary Objective: Secondary parameters will include the Neuro-Phisiological index NI , FVC , the SF-36 quality of life rating scale and the number of patients showing an improvement 15 in ALSFRS-R slope as compared to the lead-in period responders .;Primary end point(s): Primary evaluation parameter will be the ALSFRS-R Cederbaum et al, 1999 according to the consensus conference on designing and implementing clinical trials in ALS Leigh et al., 2004 . Primary endpoint will be the ALSFRS-R slope during the treatment period as compared to the lead-in period. Safety evaluation Incidence, severity and type of adverse events,; changes in clinical laboratory findings. | — |
Countries
Italy
Outcome results
None listed