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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.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2005-005152-40-IT
Date of registration: 07/04/2006
Prospective Registration: Yes
Primary sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
Public title: MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALS
Scientific title: MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALS
Date of first enrolment: 19/04/2006
Target sample size: 84
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005152-40
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Italy
Contacts
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Key inclusion & exclusion criteria
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
ALS
MedDRA version: 6.1 Level: PT Classification code 10002026
Intervention(s)

Product Name: ALPHA-LIPOIC ACID
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Tioctic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
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.
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 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
Secondary Outcome(s)
Secondary ID(s)
ALALS
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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