Intermediate-size Patient Population Expanded Access Protocol

Available (expanded access)

Conditions studied: ALS (Amyotrophic Lateral Sclerosis)

In brief

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.

Key facts

Study ID

NCT07088159

Run by

Spinogenix

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Mayo Scottsdale — Scottsdale, Arizona, United States
• Kaiser Permanente Los Angeles — Los Angeles, California, United States
• Cedar-Sinai Medical Center — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Nova Southeastern University — Davie, Florida, United States
• Synapticure — Chicago, Illinois, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Atlantic Health — Summit, New Jersey, United States
• New Mexico VA Health Care System — Albuquerque, New Mexico, United States
• NYU Langone Health — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• VCU ALS Research Group — Henrico, Virginia, United States

Full record on ClinicalTrials.gov

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