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.
– 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
– 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
– Use of tracheostomy or >22/24-hour ventilatory support.
- University of California, Orange, California, United States, 92868