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

Description

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.

Conditions

Amyotrophic Lateral Sclerosis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Amyotrophic Lateral Sclerosis
Intervention / Treatment

-

Contacts and Locations

Orange

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

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Augusta

Augusta University, Augusta, Georgia, United States, 30912

Indianapolis

Indiana University IU Health Neuroscience Center, Indianapolis, Indiana, United States, 46202

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Minneapolis

Hennepin Healthcare Research Institute, Minneapolis, Minnesota, United States, 55415

Syracuse

SUNY Upstate Medical University, Syracuse, New York, United States, 13210

Durham

Duke University, Durham, North Carolina, United States, 27705

Allentown

Lehigh Valley Health Network, Allentown, Pennsylvania, United States, 18103

Charlottesville

University of Virginia Health System, Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MediciNova,

Project Management Team, STUDY_CHAIR, Medicinova Inc

Study Record Dates

2026-12