Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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:
a. Time since onset of weakness due to ALS > 36 months
b. Vital Capacity less than 50% of predicted capacity for age, height, and sex measured (by Slow Vital Capacity (SVC) or Forced Vital Capacity (FVC))
c. 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.
d. 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) Fully completed participant in COMBAT-ALS clinical trial including OLE
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 ibudilast.
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 ibudilast.
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, thyroid-stimulating hormone (TSH) levels >10 mIU/L or <0.01 mIU/L.
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 medications that are substrates for major drug transporters
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 09/11/2024. Questions regarding updates should be directed to the study team contact.