About this trial
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.
Eligibility criteria
Qualifiers
ALS by "Gold Coast" diagnostic criteria
Age > 18 years
Either I) Ineligibility for interventional ALS clinical research participation due to at least one of the following standard
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MN-166
Treatment groups
Sponsors and collaborators
Mayo Clinic
Lead sponsor
WideTrial, Inc.
Collaborator
MediciNova
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator