This is a multi-site, intermediate-size patient population expanded access protocol developed to provide compassionate use access to tazbentetol to adult patients with ALS who have progressed following available standard of care.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
ALS diagnosis
Age 18 -85 years at time of signing informed consent form
Ineligible for other interventional ALS clinical research participation
Vital Capacity greater than 35% of predicted capacity for age, height, and sex
If currently taking standard of care treatment for ALS, must be on stable dose for at least 30 days prior to taking tazbentetol.
Life expectancy of at least 6 months, according to Investigator's judgement
You may not be if
Clinically significant and/or unstable medical condition (other than ALS) that would pose a risk to the patient
Known ongoing or clinically uncontrolled cardiac disease
Clinically significant liver disease
Clinical significant cognitive impairment or neurological disorder, as determined by Investigator judgement
Concomitant use of another investigational medical product for treatment of ALS
Unable to reliably and regularly swallow whole oral medications on a daily basis
Clareo Health | Intermediate-size Patient Population Expanded Access Protocol
