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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 an Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis

Study 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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Kazuko W Matsuda, MD, PhD, MPH, Medicinova Inc

Clinicaltrials.gov ID (11 digit #):

NCT04057898

Neals Affiliated?

No

Coordinating Center Contact Information


Joanna Dojillo, MMSc / .(JavaScript must be enabled to view this email address) / 858-373-1500 ext 118
.(JavaScript must be enabled to view this email address) United States

Full Study Summary:

Study Sponsor:

MediciNova

Participant Duration:

Estimated Enrollment:

230

Estimated Study Start Date:

05/28/2020

Estimated Study Completion Date:

12/31/2024

Posting Last Modified Date:

07/02/2020

Date Study Added to alsconsortium.org:

07/02/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Min Vital Capacity (% predicted normal):

    70

    Time since Symptom Onset:

    <18 months

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    • Male or female subjects age 18 to 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;
    • Slow vital capacity ≥ 70% of predicted at screening
    • Currently on a stable dose of riluzole for at least 30 days prior to initiation of study drug;
    • 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.

    Exclusion Criteria:

    • ALSFRS-R score of ≤ 1 on more than one item in the assessment's individual components;
    • Current use or treated with Edaravone® ≤ 3 months prior to signing consent;
    • Current use or treated with Nuedexta® ≤ 3 months prior to signing consent;
    • Current 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, tracheostomy invasive mechanical ventilation [TIMV].

  • Site Contact Information

    Mayo Clinic
    Jany Paulett / .(JavaScript must be enabled to view this email address) / 904-953-3730
    Megan Donahue / .(JavaScript must be enabled to view this email address) / 904-953-3647
    Jacksonville, Florida 32224
    United States