Scalable Expanded Access With Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS

NCT06743776 | Unknown

• 2 other identifiers: 24-009898U01NS136022
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

ALS

Interventions

MN-166 DRUG

MN-166 will be taken orally at a dose of 10 mg in the morning and 20 mg in the evening for the first 2 weeks, whereafter dose of 30 mg BID will be taken.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ALS by "Gold Coast" diagnostic criteria
• Age \> 18 years

You may not qualify if:

• Time since onset of weakness due to ALS \> 36 months
• Vital Capacity less than 50% of predicted capacity for age, height, and sex measured (by Slow Vital Capacity (SVC) or Forced Vital Capacity (FVC))
• 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.
• 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.
• 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.
• 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.
• 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).
• 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
• Active drug or alcohol abuse
• Female patient is lactating, pregnant, or planning pregnancy at Clinical Screening or Lab Screening
• 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.
• Concomitant use of prohibited medications. Refer to Program Procedure Manual Appendix 3 for a list of prohibited medications.
• Past participant in COMBAT-ALS clinical trial who did not complete the study.
• Past participant in an ALS research trial who did not complete the study without cause.

Sponsors & Collaborators

• Mayo Clinic: lead
• WideTrial, Inc.: collaborator
• MediciNova: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (15)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

AVAILABLE

UCI Health

Orange, California, 92868, United States

AVAILABLE

University of California, San Francisco

San Francisco, California, 94143, United States

AVAILABLE

Hospital for Special Care

New Britain, Connecticut, 06053, United States

AVAILABLE

Nova Southeastern University

Davie, Florida, 33314, United States

AVAILABLE

Mayo Clinic

Jacksonville, Florida, 32224, United States

AVAILABLE

Augusta University

Augusta, Georgia, 30912, United States

AVAILABLE

Indiana University - IU Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

AVAILABLE

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

AVAILABLE

Mayo Clinic

Rochester, Minnesota, 55905, United States

AVAILABLE

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

AVAILABLE

Duke University

Durham, North Carolina, 27705, United States

AVAILABLE

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

AVAILABLE

Semmes Murphey Foundation

Memphis, Tennessee, 38120, United States

AVAILABLE

University of Virginia

Charlottesville, Virginia, 22908, United States

AVAILABLE

MeSH Terms

Interventions

ibudilast

Study Officials

• Bjorn E Oskarsson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colette McHugh Strong

CONTACT

904-953-4965; McHugh-Strong.Colette@mayo.edu

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 20, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-01

Locations

US (15)