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

  • STATUS
    Recruiting
  • End date
    Dec 6, 2024
  • participants needed
    230
  • sponsor
    MediciNova
Updated on 6 September 2021
pulmonary function test
weakness
riluzole
edaravone
ibudilast
swallow study

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.

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.

Details
Condition Myelopathy, Amyotrophic Lateral Sclerosis, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, lou gehrig's disease
Treatment Placebo, MN-166
Clinical Study IdentifierNCT04057898
SponsorMediciNova
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

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

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
Use of tracheostomy or >22/24-hour ventilatory support
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
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