Intermediate-size Patient Population Expanded Access Protocol
Purpose
The purpose of this Expanded Access Program is to provide tazbentetol to ALS patients who are not eligible to enroll in an ALS clinical trial. This Expanded Access Program will assess safety and tolerability, and clinical efficacy of tazbentelol.
Condition
- ALS (Amyotrophic Lateral Sclerosis)
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study Design
- Phase
- Study Type
- Expanded Access
Recruiting Locations
University of Alabama Birmingham
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Kaiser Permanente Los Angeles
Los Angeles, California 90027
Los Angeles, California 90027
California Pacific Medical Center
San Francisco, California 94109
San Francisco, California 94109
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
New Mexico VA Health Care System
Albuquerque, New Mexico 87108
Albuquerque, New Mexico 87108
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
More Details
- Status
- Available
- Sponsor
- Spinogenix
Detailed Description
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.