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Quick Info
Status
Available
Phase
-
Trial Type
Expanded Access
Treatment Type
Randomization
None
Enrollment
Start Date
Sponsor
Contact Information
    Contact information unknown.
Locations
United States, Other
University of Alabama Birmingham, Birmingham 4049979, 35233, United States
Contact: Melanie Benge   Melaniebenge@uabmc.edu
Massachusetts General Hospital, Boston 4930956, 02114, United States
Contact: Grace Addy   SPG302healey@mgb.org
Synapticure, Chicago 4887398, 60640, United States
Contact: Sarah Bohlman   research-studies@synapticure.com
Nova Southeastern University, Davie 4152820, 33314, United States
Contact: Donovan.mott@nova.edu
VCU ALS Research Group, Henrico 4763729, 23233, United States
Contact: neuromuscular_research@vcuhealth.org
Dartmouth-Hitchcock Medical Center, Lebanon 5088597, 03756, United States
Contact: Gina.E.Kersey@Hitchcock.ORG
Cedar-Sinai Medical Center, Los Angeles 5368361, 90048, United States
Contact: contact@spinogenix.com
Columbia University Medical Center, New York 5128581, 10032, United States
Contact: contact@spinogenix.com
Thomas Jefferson University, Philadelphia 4560349, 19107, United States
Contact: contact@spinogenix.com
California Pacific Medical Center, San Francisco 5391959, 94109, United States
Contact: Daniela Sanchez   daniela.sanchez@sutterhealth.org
Mayo Scottsdale, Scottsdale 5313457, 85259, United States
Contact: Bojko.Alissa@mayo.edu
Atlantic Health, Summit 5105127, 07901, United States
Contact: Jillian Anderson, MD   Research@atlantichealth.org
Trial Goal
Tests to Expect
Update Notes
There are no update notes for this clinical trial.

Other Information

Purpose
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.
Eligibility
Inclusion Criteria:
- ALS diagnosis - Age 18 -80 years at time of signing informed consent form - Ineligible for other interventional ALS clinical research participation - Vital Capacity less than 50% 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 Exclusion Criteria:
- 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
Details
This is a multi-site, intermediate-size patient population expanded access protocol developed to provide compassionate use access to SPG302 to adult patients with ALS who have progressed following available standard of care.
Collaborator(s)
  • Spinogenix
Trial Protocol as Published on Clinicaltrials.gov
NCT07088159 (First Published: 7/18/2025)