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

Launched by MEDICINOVA · Aug 13, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medication called MN-166 (ibudilast) to see if it can help patients with Amyotrophic Lateral Sclerosis (ALS) over a period of 12 months, followed by an additional 6 months where all participants will receive the medication. The goal is to find out how effective and safe this treatment is for people diagnosed with ALS, which is a progressive disease that affects nerve cells in the brain and spinal cord.

To participate, individuals must be between 18 and 80 years old and have a confirmed diagnosis of ALS, either familial (runs in families) or sporadic (occurs randomly). They should have experienced symptoms for less than 18 months and meet certain health criteria, such as having good lung function and being able to swallow capsules. During the trial, participants can expect regular check-ups and assessments to monitor their health and how well the medication works for them. It's also important to know that this trial is currently recruiting participants, and it aims to provide valuable insights into potential new treatments for ALS.

Gender

ALL

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.