ALS MedDRA version: 9.1 Level: SOC Classification code 10029205
Conditions
Interventions
Trade Name: EPREX*1SIR 40000UI/ML 1ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Erythropoietin
Concentration unit: U unit(s)
Concentration type: equal
Concentrati
Sponsors
ISTITUTO NEUROLOGICO "CARLO BESTA"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age 18-75 years FVC >=70% of predicted onset of weakness =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: any contraindication to the use of rhEPO tracheotomy or >23h of non-invasive ventilation daily for 14 consecutive days first-degree relative with ALS diagnosis of neurodegenerative disease in addition to ALS history of myocardial infarction or thrombotic vascular events (such as stroke, transient ischemic attack, pulmonary emboli, deep vein, arterial, retinal thrombosis), clinically evident cardiac disease (ischemic heart disease or congestive heart failure), uncontrolled hypertension, active malignancy, polycythemia, myeloproliferative disorder, hypercoagulable disorders, porphyria, known hypersensitivity to human albumin history of unstable medical condition in the previous 2 years female subjects pregnant or lactating use of experimental drug or participation in a clinical trial within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirm safety and tolerability of rhEPO administration over 18 months;Secondary Objective: confirm the efficacy of rhEPO in changing the course of ALS;Primary end point(s): 1.survival rate 2. proportion of patients who underwent tracheotomy or >23 h non-invasive ventilation daily for 14 consecutive days 3. adverse events causing treatment withdrawal. They will be defined as: hypersensitivity reactions, any thrombotic vascular events | — |
Countries
Italy
Outcome results
None listed