Eligibility
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,
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.
Exclusion Criteria
1. 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).
2. 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.
3. Active drug or alcohol abuse.
4. Female patient is lactating, pregnant, or planning pregnancy at Screening A or
Screening B.
5. Concomitant use of another investigational medical product for treatment of ALS.
6. Concomitant use of prohibited medications. Refer to Program Procedure Manual
Appendix 3 for a list of prohibited medications.
7. Past participant in COMBAT-ALS clinical trial who did not complete the study.
8. Past participant in an ALS research trial who did not complete the study without
cause.