Summary

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

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;
  • Currently on a stable dose of riluzole for at least 30 days prior to initiation of study drug;
  • If currently using edaravone, subject should have completed at least one cycle of edaravone prior to Screening visit;
  • 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 use or treated with Nuedexta® ≤3 months prior to signing consent;
  • Currently use or treated with Methylcobalamin Vitamin B12 ≤3 months prior to signing consent
  • Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator;
  • Use of tracheostomy or >22/24-hour ventilatory support.

Locations

  • University of California accepting new patients
    Orange California 92868 United States
  • SUNY Upstate Medical University accepting new patients
    Syracuse New York 12310 United States

Lead Scientist at UC Irvine

  • Namita Goyal, MD
    Associate Clinical Professor, Neurology. Authored (or co-authored) 29 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MediciNova
ID
NCT04057898
Phase
Phase 2/3
Study Type
Interventional
Last Updated