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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Project Management Team
• Email: clinicaltrialinfo@medicinova.com
• Phone: 858-373-1500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.