Efficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - ND
Active, not recruiting
- Conditions
- Amyotrophic lateral sclerosis (ALS)MedDRA version: 6.1Level: PTClassification code 10002026
- Registration Number
- EUCTR2007-004165-17-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA PISANA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assessment of the effects of intravenous administration in patients with ALS.;Secondary Objective: Assessment of the safety of intravenous administration in patients with ALS.;Primary end point(s): Assessment of survival.
- Secondary Outcome Measures
Name Time Method