Scalable Expanded Access With Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS (SEANOBI-ALS)

The purpose of this Expanded Access Program is to provide MN-166 (ibudilast) to ALS patients who are not eligible for an enrolling ALS clinical trial. This Expanded Access Program will assess if MN-166 can help people with ALS in slowing down the progression of the disease.

Study Overview

• Status: Available
• Conditions: ALS
• Intervention / Treatment: Drug: MN-166

• Study Type: Expanded Access
• Expanded Access Type: Intermediate-size Population

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Available
      • Mayo Clinic
  • California
    • Orange, California, United States, 92868
      • Available
      • UCI Health
    • San Francisco, California, United States, 94143
      • Available
      • University of California, San Francisco
  • Connecticut
    • New Britain, Connecticut, United States, 06053
      • Available
      • Hospital for Special Care
  • Florida
    • Davie, Florida, United States, 33314
      • Available
      • Nova Southeastern University
    • Jacksonville, Florida, United States, 32224
      • Available
      • Mayo Clinic
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Available
      • Augusta University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Available
      • Indiana University - IU Health Neuroscience Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Available
      • Hennepin Healthcare Research Institute
    • Rochester, Minnesota, United States, 55905
      • Available
      • Mayo Clinic
  • New York
    • Syracuse, New York, United States, 13210
      • Available
      • SUNY Upstate Medical University
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Available
      • Duke University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Available
      • Lehigh Valley Health Network
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Available
      • Semmes Murphey Foundation
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Available
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. ALS by "Gold Coast" diagnostic criteria
2. Age > 18 years

3. Either I) Ineligibility for interventional ALS clinical research participation due to at least one of the following standard exclusion criteria:

   1. Time since onset of weakness due to ALS > 36 months
   2. Vital Capacity less than 50% of predicted capacity for age, height, and sex measured (by Slow Vital Capacity (SVC) or Forced Vital Capacity (FVC))
   3. Cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.
   4. Geographic inaccessibility from nearest actively enrolling research trial site for a trial the patient would otherwise qualify for, defined as either >200 miles or, in the opinion of the investigator, a distance that would make trial participation infeasible for the particular patient, due to significant disease progression or special logistical circumstances. OR II) Former COMBAT-ALS participant or current participant who has completed dosing in the OLE and may be consented at the final OLE follow-up visit.
4. Female patients of childbearing potential must use one or more effective methods of contraception throughout the entire EAP and for 30 days after discontinuing MN-166.
5. Male patients agree to practice contraception (e.g., condom use and contraception by female partner) unless partner is post-menopausal or unable to conceive throughout the entire EAP and for 30 days after discontinuing MN-166.

Exclusion Criteria

1. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to treating physician's judgment (e.g., psychiatric, cardiovascular instability, systemic infection, untreated thyroid dysfunction, or clinically significant laboratory abnormality or ECG changes).
2. Clinically significant lab abnormalities in the opinion of the treating physician, including, but not limited to: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin greater than 3 times the upper limit of normal (ULN), white blood cell count <2500/mm3, platelet count <75,000/mm3
3. Active drug or alcohol abuse
4. Female patient is lactating, pregnant, or planning pregnancy at Clinical Screening or Lab Screening
5. Concomitant use of another investigational medical product for treatment of ALS. Any such investigational medical product must be discontinued for a minimum of 5 half-lives prior to the first dose of MN-166.
6. Concomitant use of prohibited medications. Refer to Program Procedure Manual Appendix 3 for a list of prohibited medications.
7. Past participant in COMBAT-ALS clinical trial who did not complete the study.
8. Past participant in an ALS research trial who did not complete the study without cause.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); MediciNova; WideTrial, Inc.
• Investigators: Principal Investigator: Bjorn E Oskarsson, MD, Mayo Clinic

Study record dates

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Vasodilator Agents; Phosphodiesterase Inhibitors; ibudilast
• Other Study ID Numbers: 24-009898; U01NS136022 (U.S. NIH Grant/Contract)