Status:
ACTIVE_NOT_RECRUITING
Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
Lead Sponsor:
MediciNova
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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 followe...
Detailed Description
This is a Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 followed by an open-label extension pha...
Eligibility Criteria
Inclusion
- Major
- 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
- 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.
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT04057898
Start Date
May 28 2020
End Date
December 1 2026
Last Update
September 16 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California
Orange, California, United States, 92868
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
3
Augusta University
Augusta, Georgia, United States, 30912
4
Indiana University IU Health Neuroscience Center
Indianapolis, Indiana, United States, 46202