ALS Drug Combination Testing Moves to Next Stage

A phase 2 trial to test two drug combinations for the treatment of amyotrophic lateral sclerosis (ALS) has completed its first stage, according to Avicena Group, developers of ALS-08, one of the compounds in the trial. Eighty-six patients have participated so far.

The multicenter trial is being coordinated by neurologist Paul Gordon, co-director of the Eleanor and Lou Gehrig MDA/ALS Center at Columbia University Medical Center in New York.

One randomly assigned group of ALS patients received ALS-08, a creatine derivative, with minocycline, an antibiotic with anti-inflammatory and neuroprotective properties. The other randomly assigned group received ALS-08 with celecoxib (Celebrex), an anti-inflammatory medication. The superior combination, based on participants’ scores on the ALSFRS-R (revised ALS Functional Rating Scale), will go on for further testing in a large-scale, phase 3 trial.

If the average difference between the two treatment groups from this first stage reaches a pre-defined value, the drug combination selection phase of this trial will be judged to be complete, and the winning combination will go on for further testing.

If the pre-defined difference isn’t reached, the investigators plan to randomly assign to the two treatment groups some 60 additional patients, after which the better combination will go on to phase 3 testing.

For details about this study, see Combination Drug Selection Trial.