Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)

What Was Tested

The trial (phase 2) is built around Glatiramer Acetate.

GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

Pre-filled syringe of matching placebo, administered subcutaneously once a day.

The registry classes the interventions as drug.

Who Took Part

366 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria. Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points. Age - 18-70 (inclusive).

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: the use of invasive or non-invasive ventilation; subject having undergone gastrostomy; subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Glatiramer Acetate group and the comparison group should start out alike.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Glatiramer Acetate, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2006-07-27 with completion listed for 2008-06-17.

It ran at 7 sites in Belgium (2), France (1), Germany (1), Israel (1), Italy (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R) (time frame: Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 366 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glatiramer Acetate compound page, all human trials.