Evaluating MN-166 for treating ALS over 12 months with an 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

This study is testing if a new treatment called MN-166 can help people with ALS feel better over a year, with an option to continue for another six months.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: MediciNova (Industry-sponsored)
• Locations: 16 sites (Orange, California and 15 other locations)
• Trial ID: NCT04057898 on ClinicalTrials.gov

What this trial studies

This is a Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and tolerability of MN-166 in patients diagnosed with amyotrophic lateral sclerosis (ALS). Participants will undergo a screening phase followed by a 12-month double-blind treatment phase where they will be randomly assigned to receive either MN-166 or a matching placebo. After this phase, eligible participants will have the option to continue into a 6-month open-label extension phase. The study aims to provide insights into the potential benefits of MN-166 for ALS patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with a diagnosis of familial or sporadic ALS and a disease onset of 18 months or less.

Not a fit: Patients with advanced ALS or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the quality of life and disease progression for patients with ALS.

How similar studies have performed: Previous studies have shown promise in treating ALS with similar approaches, but this specific application of MN-166 is novel.

Eligibility 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:

* 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.

Where this trial is running

Orange, California and 15 other locations

• University of California — Orange, California, United States (Recruiting)
• Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
• Augusta University — Augusta, Georgia, United States (Recruiting)
• Indiana University IU Health Neuroscience Center — Indianapolis, Indiana, United States (Recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• Hennepin Healthcare Research Institute — Minneapolis, Minnesota, United States (Recruiting)
• SUNY Upstate Medical University — Syracuse, New York, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States (Recruiting)
• University of Virginia Health System — Charlottesville, Virginia, United States (Recruiting)
• University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
• McMaster University Medical Center — Hamilton, Ontario, Canada (Recruiting)
• Sunnybrook Research Institute — Toronto, Ontario, Canada (Recruiting)
• Montreal Neurological Institute and Hospital — Montreal, Quebec, Canada (Recruiting)
• University of Saskatchewan - Sastakoon Hospital — Saskatoon, Saskatchwean, Canada (Recruiting)
• Hopital de L'Enfant-Jesus, CHU de Quebec-Universite Laval — Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Project Management Team

Conditions Amyotrophic Lateral Sclerosis; ALS; MN-166; ibudilast; amyotrophic lateral sclerosis