Intermediate-size Patient Population Expanded Access Protocol
1 other identifier
expanded_access
N/A
1 country
14
Brief Summary
The purpose of this Expanded Access Program is to provide SPG302 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 SPG302.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedMarch 24, 2026
March 1, 2026
July 18, 2025
March 21, 2026
Conditions
Keywords
Interventions
300 mg SPG302 will taken by mouth once daily.
Eligibility Criteria
You may qualify if:
- ALS diagnosis
- Age 18 -80 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 SPG302.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spinogenixlead
Study Sites (14)
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Mayo Scottsdale
Scottsdale, Arizona, 85259, United States
Kaiser Permanente Los Angeles
Los Angeles, California, 90027, United States
Cedar-Sinai Medical Center
Los Angeles, California, 90048, United States
California Pacific Medical Center
San Francisco, California, 94109, United States
Nova Southeastern University
Davie, Florida, 33314, United States
Synapticure
Chicago, Illinois, 60640, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Atlantic Health
Summit, New Jersey, 07901, United States
Columbia University Medical Center
New York, New York, 10032, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
VCU ALS Research Group
Henrico, Virginia, 23233, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
March 24, 2026
Record last verified: 2026-03