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

Mayo Clinic

Status

Conditions: ALS

Treatments: Drug: MN-166

Study type: Expanded Access

Funder types: Other; Industry; NIH

Identifiers

NCT06743776

24-009898

U01NS136022 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• ALS by "Gold Coast" diagnostic criteria

• Age > 18 years

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

  • 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 isolation from nearest actively enrolling research trial location, defined as either >75 miles or >120-minute travel time
  • OR II) Completed assigned regimen as participant in COMBAT-ALS clinical trial.

Exclusion Criteria

• 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 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, thyroid-stimulating hormone (TSH) levels >10 mIU/L or <0.01 mIU/L.
• Active drug or alcohol abuse
• Concomitant use of another investigational medical product for treatment of ALS