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

Investigational Medication for ALS: Expanded Access Program

C
Cynthia Bodkin, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
2 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

This Expanded Access Program offers access for patients with ALS who are not eligible for clinical trials to receive the investigational agent MN-166. MN-166 is currently in a phase 2/3 clinical trial, and funding for the program will be through the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS; P.L. 117-79).

Drug: 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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Amyotrophic lateral sclerosis, ALS
  • Age: 18 years - 100 years
  • Gender: All

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, 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 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.

This study investigates an Expanded Access Program for people with Amyotrophic Lateral Sclerosis (ALS). ALS is a disease that affects nerve cells in the brain and spinal cord, leading to loss of muscle control. The purpose of this program is to provide access to an investigational medication for ALS patients who cannot join other clinical trials.

Participants will take the investigational medication orally. The dose starts at 10 mg in the morning and 20 mg in the evening for the first two weeks, then increases to 30 mg twice a day. This program aims to observe the effects of the medication on ALS progression.

  • Who can participate: Adults over 18 with ALS who cannot join other clinical trials due to specific reasons. Contraception is required for participants unless their partner cannot conceive.
  • Study details: Participants will take the investigational medication by mouth. The dose starts lower and increases after two weeks. Participants must follow contraception guidelines during the study.
Updated on 05 Nov 2025. Study ID: NEUR-MAYO-SEA-NOBI-ALS, 28763
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only