MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALS
- Conditions
- ALSMedDRA version: 6.1Level: PTClassification code 10002026
- Registration Number
- EUCTR2005-005152-40-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
PROBABo E PR DEFINITE ALS, AGE BETWEEN 30 AND 70 YEARS, DISEASE DURATION LESS THAN 18 MONTHS
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
FAMILIAL ALS, SERIOUS MEDICAL CONDITIONS, CANCERS
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: THE PRIMARY END-POINT IS THE RATE OF CASES WHO WILL BE NOT SELF-SUFFICIENT DURING THE 12 MONTHS OF FOLLOW-UP. NON SELF-SUFFICIENT IS A RATE OF 1 OR LESS AT THE ITEMS SWALLOWING, FEED THEMSELVES OR WALKING AT ALS-FRS-R.;Secondary Objective: SECONDARY END-POINTS WILL BE A TOTAL DISABILITY SCORES mrc, als-rfs-r B DEATH C THERAPEUTIC FAILURES TREATMENT WITHDRAWAL DUE TO THERAPEUTIC FAILUREAND/OR ae D TOTAL SCORE AT MCGILL AT 3 AND 12 MONTHS;Primary end point(s): THE PRIMARY END-POINT IS THE RATE OF CASES WHO WILL BE NOT SELF-SUFFICIENT DURING THE 12 MONTHS OF FOLLOW-UP. NON SELF-SUFFICIENT IS A RATE OF 1 OR LESS AT THE ITEMS SWALLOWING, FEED THEMSELVES OR WALKING AT ALS-FRS-R.
- Secondary Outcome Measures
Name Time Method