ACTIVE_NOT_RECRUITING

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

Conditions

Amyotrophic Lateral Sclerosis ALS MN-166 ibudilast

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-05-28

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04057898

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Project Management Team

STUDY_CHAIR

Medicinova Inc

Study Locations (Sites)

University of California

Orange, California, 92868

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

Augusta University

Augusta, Georgia, 30912

United States

Indiana University IU Health Neuroscience Center

Indianapolis, Indiana, 46202

United States

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415

United States

SUNY Upstate Medical University

Syracuse, New York, 13210

United States

Duke University

Durham, North Carolina, 27705

United States

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103

United States

University of Virginia Health System

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: MediciNova

Project Management Team, STUDY_CHAIR, Medicinova Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-28

Study Completion Date2026-12

Study Record Updates

Study Start Date2020-05-28

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

ALS
MN-166
ibudilast
amyotrophic lateral sclerosis

Additional Relevant MeSH Terms

Amyotrophic Lateral Sclerosis