Intermediate-size Patient Population Expanded Access Protocol
NCT ID: NCT07088159
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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SPG302
300 mg SPG302 will taken by mouth once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Spinogenix
INDUSTRY
Responsible Party
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Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Mayo Scottsdale
Scottsdale, Arizona, United States
Cedar-Sinai Medical Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
Nova Southeastern University
Davie, Florida, United States
Synapticure
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Atlantic Health
Summit, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
VCU ALS Research Group
Henrico, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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SPG302-ALS-ISEAP
Identifier Type: -
Identifier Source: org_study_id