Intermediate-size Patient Population Expanded Access Protocol

NCT07088159 | Unknown

• 1 other identifier: SPG302-ALS-ISEAP
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Keywords

Expanded Access Protocol; synapse; ALS (Amyotrophic Lateral Sclerosis); neural connectivity; tazbentelol

Interventions

Tazbentetol DRUG

300 mg Tazbentetol will taken by mouth once daily.

Also known as: SPG302

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Spinogenix: lead

Study Sites (15)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

AVAILABLE

Mayo Scottsdale

Scottsdale, Arizona, 85259, United States

AVAILABLE

Kaiser Permanente Los Angeles

Los Angeles, California, 90027, United States

AVAILABLE

Cedar-Sinai Medical Center

Los Angeles, California, 90048, United States

AVAILABLE

California Pacific Medical Center

San Francisco, California, 94109, United States

AVAILABLE

Nova Southeastern University

Davie, Florida, 33314, United States

AVAILABLE

Synapticure

Chicago, Illinois, 60640, United States

AVAILABLE

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

AVAILABLE

Atlantic Health

Summit, New Jersey, 07901, United States

AVAILABLE

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108, United States

AVAILABLE

NYU Langone Health

New York, New York, 10017, United States

AVAILABLE

Columbia University Medical Center

New York, New York, 10032, United States

AVAILABLE

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

AVAILABLE

Baylor College of Medicine

Houston, Texas, 77030, United States

AVAILABLE

VCU ALS Research Group

Henrico, Virginia, 23233, United States

AVAILABLE

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Project Lead

CONTACT

1 (661) 862-7122; als302eap@cbcc.global

Spinogenix Lead, PhD

CONTACT

1 310 853-5695; studyiseap@spinogenix.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 28, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

US (15)