Intermediate-size Patient Population Expanded Access Protocol
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.
Condition
- ALS (Amyotrophic Lateral Sclerosis)
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Expanded Access
Recruiting Locations
University of Alabama Birmingham
Birmingham 4049979, Alabama 4829764 35233
Birmingham 4049979, Alabama 4829764 35233
Cedar-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90048
California Pacific Medical Center
San Francisco 5391959, California 5332921 94109
San Francisco 5391959, California 5332921 94109
Synapticure
Chicago 4887398, Illinois 4896861 60640
Chicago 4887398, Illinois 4896861 60640
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
Dartmouth-Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756
Lebanon 5088597, New Hampshire 5090174 03756
Atlantic Health
Summit 5105127, New Jersey 5101760 07901
Summit 5105127, New Jersey 5101760 07901
Columbia University Medical Center
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
VCU ALS Research Group
Henrico 4763729, Virginia 6254928 23233
Henrico 4763729, Virginia 6254928 23233
More Details
- Status
- Available
- Sponsor
- Spinogenix
Detailed Description
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.