Scalable Expanded Access With Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS
NCT ID: NCT06743776
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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MN-166
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
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Inclusion Criteria
2. Age \> 18 years
Exclusion Criteria
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, 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.
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 including, but not limited to: hemoglobin \< 10 g/dL, white blood cells \< 3.0 x 103/mm3, neutrophils, absolute ≤ 1000/mm3, eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter), low platelet counts (\< 150 x 109 per liter), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN), eGFR \< 30 mL/min/1.73m2.
3. Active drug or alcohol abuse.
4. Female patient is lactating, pregnant, or planning pregnancy at Screening A or Screening B.
5. Concomitant use of another investigational medical product for treatment of ALS.
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.
18 Years
ALL
No
Sponsors
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WideTrial, Inc.
INDUSTRY
MediciNova
INDUSTRY
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Mayo Clinic
OTHER
Responsible Party
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Bjorn E. Oskarsson
Associate Professor of Neurology
Principal Investigators
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Bjorn E Oskarsson, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
University of California, San Francisco
San Francisco, California, United States
Hospital for Special Care
New Britain, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
Augusta University
Augusta, Georgia, United States
Indiana University - IU Health Neuroscience Center
Indianapolis, Indiana, United States
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Duke University
Durham, North Carolina, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Semmes Murphey Foundation
Memphis, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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24-009898
Identifier Type: -
Identifier Source: org_study_id
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