Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mayo Clinic
With
WideTrial, Inc.
MediciNova
National Institute of Neurological Disorders and Stroke (NINDS)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. ALS by "Gold Coast" diagnostic criteria
2. Age \> 18 years
You may not be if
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.
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 in the opinion of the treating physician, including, but not limited to: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin greater than 3 times the upper limit of normal (ULN), white blood cell count \<2500/mm3, platelet count \<75,000/mm3
3. Active drug or alcohol abuse
4. Female patient is lactating, pregnant, or planning pregnancy at Clinical Screening or Lab Screening
5. Concomitant use of another investigational medical product for treatment of ALS. Any such investigational medical product must be discontinued for a minimum of 5 half-lives prior to the first dose of MN-166.
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.
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