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Main
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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: |
EUCTR2007-004165-17-IT |
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Date of registration:
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15/10/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - ND
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Scientific title:
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Efficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - ND |
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Date of first enrolment:
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25/09/2007 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004165-17 |
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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: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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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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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
a. definitive ALS, probable or probable with laboratory support; b. age > 18 years; c. disease duration < 36 months; d. patients in treatment with standard dose of riluzole, in association (or not) with E vitamin (400 mg/die for 30 days every 3 months) as antioxidant; e. negative pregnancy test.
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:
a. motoneuron disease except ALS; b. poor compliance with previous treatment; c. patients involved in other clinical trials; d. patients with history of sensitivity or intolerance to cephalosporins.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Amyotrophic lateral sclerosis (ALS)
MedDRA version: 6.1
Level: PT
Classification code 10002026
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Intervention(s)
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Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Ceftriaxone
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
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Primary Outcome(s)
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Secondary Objective: Assessment of the safety of intravenous administration in patients with ALS.
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Main Objective: Assessment of the effects of intravenous administration in patients with ALS.
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Primary end point(s): Assessment of survival.
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Secondary ID(s)
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2289/2007
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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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