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# MediciNova ALS Pivotal Trial Gets FDA Backing
- URL: https://www.fdaweb.com/medicinova-als-pivotal-trial-gets-fda-backing/
- Published: 2019-04-19T12:00:00.000Z
- Updated: 2026-09-15T01:21:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143916

FDA has given approval for MediciNova to proceed with a Phase 2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) patients. If the pivotal trial is successful, data will be used to support a future NDA, according to the company. FDA concurred, it says, on the trial’s design, which includes the following elements:

- Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-166 (ibudilast) vs. placebo in about 150 ALS patients in the U.S.;
- Patients will be randomized 1:1 to receive either 100 mg/day MN-166 (ibudilast) or placebo for nine months;
- The primary endpoint is the mean change in functional activity at nine months as measured by the ALSFRS-R score (Amyotrophic Lateral Sclerosis Functional Rating Scale-revised);
- Secondary endpoints include mean change from baseline of muscle strength and quality of life, the utilization of and time to clinically indicated prescription for non-invasive ventilation, safety and tolerability.

MediciNova adds that major inclusion criteria for trial eligibility will include ALS onset no more than 18 months before screening, at least one documented ALSFRS-R score between three and six months before screening, use of riluzole for at least 30 days before initiation of study drug, and total ALSFRS-R score of at least 35 at screening.

Ibudilast is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor inhibitor and phosphodiesterase -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors, the company says. “It attenuates activated glial cells, which play a major role in certain neurological conditions,” it says.