Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MediciNova
• Treatments: Ibudilast; Riluzole

Criteria

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 ≤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:

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

• 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.