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

ConditionALS
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorMayo Clinic

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 volunteers

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

    Drug

    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.

Treatment groups

No treatment groups listed

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