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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: |
EUCTR2005-005152-40-IT |
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Date of registration:
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07/04/2006 |
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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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MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALS
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Scientific title:
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MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALS |
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Date of first enrolment:
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19/04/2006 |
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Target sample size:
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84 |
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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:2005-005152-40 |
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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: yes
Double blind: no
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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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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ALS
MedDRA version: 6.1
Level: PT
Classification code 10002026
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Intervention(s)
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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
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Primary Outcome(s)
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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
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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.
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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.
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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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