A Study to Evaluate MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients with Amyotrophic Lateral Sclerosis (ALS)

Overview

About this study

The purpose of this study is to evaluate the effectiveness, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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].

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nathan Staff, M.D., Ph.D.

Open for enrollment

Contact information:

Michelle Turner

(507) 284-1223

Turner.Michelle@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Bjorn Oskarsson, M.D.

Open for enrollment

Contact information:

Jany Paulett C.C.R.C.

(904)953-3730

Paulett.Jany@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20479118

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