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Quick Info
Status
Available
Phase
-
Trial Type
Expanded Access
Treatment Type
Randomization
None
Enrollment
Start Date
Sponsor
Contact Information
    Contact information unknown.
Locations
United States, Alabama
University of Alabama Birmingham, Birmingham, AL, 35233, United States
Contact: Melanie Benge   Melaniebenge@uabmc.edu
United States, Arizona
Mayo Scottsdale, Scottsdale, AZ, 85259, United States
Contact: Bojko.Alissa@mayo.edu
United States, California
Cedar-Sinai Medical Center, Los Angeles, CA, 90048, United States
Contact: contact@spinogenix.com
Kaiser Permanente Los Angeles, Los Angeles, CA, 90027, United States
Contact: RE-ExpandedAccessProgram@kp.org
California Pacific Medical Center, San Francisco, CA, 94109, United States
Contact: Daniela Sanchez   daniela.sanchez@sutterhealth.org
United States, Florida
Nova Southeastern University, Davie, FL, 33314, United States
Contact: Donovan.mott@nova.edu
United States, Illinois
Synapticure, Chicago, IL, 60640, United States
Contact: Sarah Bohlman   research-studies@synapticure.com
United States, New Hampshire
Dartmouth-Hitchcock Medical Center, Lebanon, NH, 03756, United States
Contact: Gina.E.Kersey@Hitchcock.ORG
United States, New Jersey
Atlantic Health, Summit, NJ, 07901, United States
Contact: Jillian Anderson, MD   Research@atlantichealth.org
United States, New Mexico
New Mexico VA Health Care System, Albuquerque, NM, 87108, United States
Contact: Sarah.Pirio-Richardson@va.gov
United States, New York
NYU Langone Health, New York, NY, 10017, United States
Contact: SPG@nyulangone.org
Columbia University Medical Center, New York, NY, 10032, United States
Contact: alsresearch@cumc.columbia.edu
United States, Pennsylvania
Thomas Jefferson University, Philadelphia, PA, 19107, United States
Contact: Alexander.McGeary@jefferson.edu
United States, Texas
Baylor College of Medicine, Houston, TX, 77030, United States
Contact: Hala.Khan@bcm.edu
United States, Virginia
VCU ALS Research Group, Henrico, VA, 23233, United States
Contact: neuromuscular_research@vcuhealth.org
Trial Goal
Tests to Expect
Update Notes
There are no update notes for this clinical trial.

Other Information

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.
Eligibility
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
Details
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.
Collaborator(s)
  • Spinogenix
Trial Protocol as Published on Clinicaltrials.gov
NCT07088159 (First Published: 7/18/2025)