ALS (Amyotrophic Lateral Sclerosis)NCT07088159
Intermediate-size Patient Population Expanded Access Protocol
A study testing Tazbentetol in people with ALS (Amyotrophic Lateral Sclerosis), run by Spinogenix at 16 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis)
- What is being tested?
- Tazbentetol
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 16 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
- Available
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108
Sarah.Pirio-Richardson@va.gov
- Available
University of Alabama Birmingham
Birmingham, Alabama, 35233
Melanie Benge, Melaniebenge@uabmc.edu
- Available
Synapticure
Chicago, Illinois, 60640
Sarah Bohlman, research-studies@synapticure.com
- Available
Nova Southeastern University
Davie, Florida, 33314
Donovan.mott@nova.edu
- Available
VCU ALS Research Group
Henrico, Virginia, 23233
studyiseap@spinogenix.com
- Available
Baylor College of Medicine
Houston, Texas, 77030
Hala.Khan@bcm.edu
- Available
University of Kansas Medical Center
Kansas City, Kansas, 66160
Katie Lillig, CCRP, KJennens2@Kumc.edu
- Available
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Gina.E.Kersey@Hitchcock.ORG
- Available
Kaiser Permanente Los Angeles
Los Angeles, California, 90027
RE-ExpandedAccessProgram@kp.org
- Available
Cedar-Sinai Medical Center
Los Angeles, California, 90048
contact@spinogenix.com
- Available
NYU Langone Health
New York, New York, 10017
SPG@nyulangone.org
- Available
Columbia University Medical Center
New York, New York, 10032
alsresearch@cumc.columbia.edu
- Available
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Alexander.McGeary@jefferson.edu
- Available
California Pacific Medical Center
San Francisco, California, 94109
Daniela Sanchez, daniela.sanchez@sutterhealth.org
- Available
Mayo Scottsdale
Scottsdale, Arizona, 85259
Bojko.Alissa@mayo.edu
- Available
Atlantic Health
Summit, New Jersey, 07901
Jillian Anderson, MD, Research@atlantichealth.org
About this study
Official title: Intermediate-size Patient Population Expanded Access Protocol for Tazbentetol in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)
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.
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Being tested
- Tazbentetol
- Keywords
- Expanded Access Protocol, synapse, ALS (Amyotrophic Lateral Sclerosis), neural connectivity, tazbentelol
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TazbentetolDrug
Also called SPG302
300 mg Tazbentetol will taken by mouth once daily.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Spinogenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088159
- Sponsor's protocol ID
- SPG302-ALS-ISEAP
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate-size Patient Population Expanded Access Protocol for Tazbentetol in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT07088159
- Acronym / sponsor ID
- SPG302-ALS-ISEAP
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Keywords
- Expanded Access Protocol, synapse, ALS (Amyotrophic Lateral Sclerosis), neural connectivity, tazbentelol
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- SpinogenixIndustry (pharma, biotech, devices)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TazbentetolAlso: SPG302300 mg Tazbentetol will taken by mouth once daily. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tazbentetol in people with ALS (Amyotrophic Lateral Sclerosis), run by Spinogenix at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Project Lead (1 (661) 862-7122, als302eap@cbcc.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.