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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2009-016066-91-IT |
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Date of registration:
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17/11/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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SAFETY AND EFFICACY OF ERYTHROPOIETIN IN AMYOTROPHIC LATERAL SCLEROSIS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL - ND
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Scientific title:
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SAFETY AND EFFICACY OF ERYTHROPOIETIN IN AMYOTROPHIC LATERAL SCLEROSIS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL - ND |
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Date of first enrolment:
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10/03/2010 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016066-91 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
age 18-75 years FVC >=70% of predicted onset of weakness <=18 months before enrolment ritten 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:
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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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ALS
MedDRA version: 9.1
Level: SOC
Classification code 10029205
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Intervention(s)
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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
Concentration number: 40000-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Main Objective: Confirm safety and tolerability of rhEPO administration over 18 months
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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
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Secondary Objective: confirm the efficacy of rhEPO in changing the course of ALS
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Secondary ID(s)
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EPO200901
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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