Eligibility
Inclusion Criteria
- ALS by "Gold Coast" diagnostic criteria
- Age > 18 years
- Either I) Ineligibility for other interventional ALS clinical research participation
due to at least one of the following standard exclusion criteria:
- 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 isolation from nearest actively enrolling research trial location,
defined as either >75 miles or >120-minute travel time
- OR II) Completed assigned regimen as participant in COMBAT-ALS clinical trial.
Exclusion Criteria
- 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).
- 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, thyroid-stimulating hormone (TSH) levels >10 mIU/L or <0.01 mIU/L.
- Active drug or alcohol abuse
- Concomitant use of another investigational medical product for treatment of ALS