ALS
Conditions
Brief summary
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.
Interventions
DRUGMN-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.
Sponsors
Mayo Clinic
WideTrial, Inc.
MediciNova
National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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. 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.
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBjorn E Oskarsson, MD
Mayo Clinic
Outcome results
None listed