Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

  • ALSFRS-R score of ≤1 on more than one item in the assessment's individual components; - 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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MN-166
Subjects will take MN-166 10 mg capsules, up to 50 mg twice a day for 12 months.
  • Drug: MN-166
    Subjects will take MN-166 for 12 months followed by a 6-month open-label extension phase.
    Other names:
    • ibudilast
Placebo Comparator
placebo
Subjects will take up to 5 matching placebo capsules twice a day for 12 months.
  • Drug: placebo
    Subjects will take matching placebo for 12 months followed by a 6-month open-label extension phase.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Collin Gerringer
913-574-0008
cgerringer@kumc.edu

More Details

Status
Recruiting
Sponsor
MediciNova

Study Contact

Kazuko Matsuda, MD, PhD, MPH
858-373-1500
inquiries@medicinova.com

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 phase compared to matching placebo in subjects diagnosed with ALS. The study will consist of a screening phase (up to 30 days) followed by a double-blind phase (12 months). Following the screening phase, subjects who continue to meet entry criteria will be randomly assigned to one of two treatment groups: MN-166 or matching placebo in a 1:1 ratio. Upon completion of the double-blind phase, subjects will be given the option to continue to the Open-label Extension Phase for a period of six months.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.