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

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

  • Amyotrophic Lateral Sclerosis

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

  • 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.

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

More Details

Status
Recruiting
Sponsor
MediciNova

Study Contact

Project Management Team
858-373-1500
clinicaltrialinfo@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.