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A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis


Brief Summary:

A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study
to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12
months followed by a 6-month open-label extension phase.


Major Inclusion Criteria:

– Male or female subjects age 18 – 80 years, inclusive;

– Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000)
research diagnostic criteria for ALS [clinically definite, clinically probable,

– ALS onset of ≤18 months from first clinical signs of weakness prior to screening;

– Currently on a stable dose of riluzole for at least 30 days prior to initiation of
study drug;

– If currently using edaravone, subject should have completed at least one cycle of
edaravone prior to Screening visit;

– Last documented pulmonary function test result (i.e., slow vital capacity or forced
vital capacity) must be greater than or equal to 70% predicted;;

– Able to swallow study medication capsules;

– No known allergies to the study drug or its excipients;

– Received pneumococcal vaccine within 6 years prior to starting clinical trial.

Major Exclusion Criteria:

– ALSFRS-R score of ≤1 on more than one item in the assessment’s individual components;

– Currently use or treated with Nuedexta® ≤3 months prior to signing consent;

– Currently use or treated with Methylcobalamin Vitamin B12 ≤3 months prior to signing

– Poor peripheral venous access that will limit the ability to draw blood as judged by
the Investigator;

– Use of tracheostomy or >22/24-hour ventilatory support.


  • University of California, Orange, California, United States, 92868
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