ClinicalTrials.gg
AvailableNCT07088159Updated Sep 25, 2026

Intermediate-size Patient Population Expanded Access Protocol

An expanded access record providing Tazbentetol in ALS (Amyotrophic Lateral Sclerosis), sponsored by Spinogenix. Available at 16 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Spinogenix · Expanded access

Updated Sep 25, 20261 site addedGo to Updates ↓
Study type
Expanded access
Access type
Intermediate-size population
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 440 studies in Amyotrophic Lateral Sclerosis with a site in United States — 98 open to participants now, 129 under way, 11 of them phase 3. Amyotrophic Lateral Sclerosis · United States.

Other kind
10 of 440
none open now
Registered
394th of 440
by date

Among the 440 studies in Amyotrophic Lateral Sclerosis with a site in United States, this one is one of 10 of another kind, and was the 394th registered.

Amyotrophic Lateral Sclerosis

979 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 278 are open to participants now.

Browse Amyotrophic Lateral Sclerosis studies →

Open to participants now

98 of the 440 studies in Amyotrophic Lateral Sclerosis with a site in United States are open now. Recruiting first, the newest first:

93 more — sign in →

All 98 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 193 Amyotrophic Lateral Sclerosis studies recruiting now, 118 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 440 studies in Amyotrophic Lateral Sclerosis with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • ALS (Amyotrophic Lateral Sclerosis)

Keywords

  • Expanded Access Protocol
  • synapse
  • ALS (Amyotrophic Lateral Sclerosis)
  • neural connectivity
  • tazbentelol
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ALS diagnosis
  • Age 18 -85 years at time of signing 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.
  • of at least 6 months, according to Investigator's judgement

Exclusion criteria

Exclusion Criteria:

  • 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 medical product for treatment of ALS
  • Unable to reliably and regularly swallow whole oral medications on a daily basis
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • 300 mg Tazbentetol will taken by mouth once daily.

    Also known as: SPG302

06

Where to request access

16 of 16 sites recruiting
  • 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
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, 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
07

Updates

1 registry update since Sep 25, 2026
Sites
1 site added
Show site
  • University of Kansas Medical Center · Kansas City, United States
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    1 site added
    Show site
    • University of Kansas Medical Center · Kansas City, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

08

Registry details

Key details

Study ID
NCT07088159
Lead sponsor
Spinogenix
Responsible party
Sponsor
First posted
Jul 28, 2025
Last update
Sep 25, 2026

Study contacts

Project Lead
Contact
als302eap@cbcc.global
1 (661) 862-7122
Spinogenix Lead, PhD
Contact
studyiseap@spinogenix.com
1 310 853-5695
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

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Discussion

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