The purpose of this Expanded Access Program is to provide SPG302 to ALS patients who arenot eligible to enroll in an ALS clinical trial. This Expanded Access Program will assesssafety and tolerability, and clinical efficacy of SPG302.
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.
Drug: SPG302
300 mg SPG302 will taken by mouth once daily.
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 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
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
University of Alabama Birmingham
Birmingham, Alabama, United States
Mayo Scottsdale
Scottsdale, Arizona, United States
Kaiser Permanente Los Angeles
Los Angeles, California, 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
Baylor College of Medicine
Houston, Texas, United States
VCU ALS Research Group
Henrico, Virginia, United States
Project Lead
1 (661) 862-7122
als302eap@cbcc.global
Spinogenix Lead, PhD
1 (503) 9151400
studyiseap@spinogenix.com
Not Provided