Multiple Sclerosis Clinical Trial
Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
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.
This is a Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 followed by an open-label extension phase compared to matching placebo in subjects diagnosed with ALS.
The study will consist of a screening phase (up to 30 days) followed by a double-blind phase (12 months). Following the screening phase, subjects who continue to meet entry criteria will be randomly assigned to one of two treatment groups: MN-166 or matching placebo in a 1:1 ratio. Upon completion of the double-blind phase, subjects will be given the option to continue to the Open-label Extension Phase for a period of six months.
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, probable-laboratory-supported];
ALS onset of â‰¤18 months from first clinical signs of weakness prior to screening;
If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiation of study drug;
If currently using edaravone, subject should have completed at least 14 days of their initial treatment cycle prior to initiation of study drug;
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:
Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT >3 times upper limit of normal);
Currently diagnosed with a clinically significant psychiatric disorder or dementia that would preclude evaluation of symptoms;
Currently use or treated with parenteral (intramuscular or intravenous) high dose (>25 mg/week) Vitamin B12 within 30 days prior to study drug administration;
Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator;
Currently participating, or has participated in a study with an investigational or marketed compound or device within 30 days or 5 half-lives, whichever is shorter, prior to signing the informed consent;
Use of tracheostomy or >22/24-hour ventilatory support.
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There are 24 Locations for this study
Rochester Minnesota, 55905, United States
New York New York, 10021, United States
Charlotte North Carolina, 28207, United States
Portland Oregon, 97213, United States
Seattle Washington, 98122, United States
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