Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Namita Goyal, MD

Description

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 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

Details

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.

Keywords

Amyotrophic Lateral Sclerosis ALS MN-166 ibudilast Motor Neuron Disease Sclerosis

Eligibility

For people ages 18-80

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:

  • 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.

Locations

  • University of California accepting new patients
    Orange California 92868 United States
  • Providence Brain and Spine Institute accepting new patients
    Portland Oregon 97213 United States

Lead Scientist at UC Irvine

  • Namita Goyal, MD
    Health Sciences Professor, Neurology. Authored (or co-authored) 37 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MediciNova
Links
This webinar explains the COMBAT-ALS study design and background of MN-166 (ibudilast) as a potential treatment for ALS.
ID
NCT04057898
Phase
Phase 2/3
Study Type
Interventional
Last Updated