MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALS

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005152-40-IT

Enrollment

Registered

2006-04-07

Start date

2006-04-19

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALS MedDRA version: 6.1 Level: PT Classification code 10002026

Interventions

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-

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: FAMILIAL ALS, SERIOUS MEDICAL CONDITIONS, CANCERS

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026