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
This trial does not accept healthy volunteersQualifiers
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
DrugMN-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.
Treatment groups
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
WideTrial, Inc.
Collaborator
MediciNova
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator