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Quick Info
Status
Currently Recruiting
Estimated Enrollment
18
Phase
Phase 1
Treatment Type
IV Drug: AP-101
Trial Type
Non-Randomized, open label
Sponsor
Primary Investigator
Primary investigator not known.
Contact Information
    Contact information unknown.
Locations
Canada, Alberta
Kaye Edmonton Clinic, University of Alberta , Edmonton, AB, Canada
Canada, Ontario
London Health Sciences Centre, University Hospital, London, ON, Canada
Sunnybrook Health Sciences Centre, Toronto , Toronto, ON, Canada
Canada, Quebec
Montreal Neurological Institute & Hospital , Montreal, QC, Canada
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
≥60% SVC
Months Since Onset
Number of months since first symptoms of ALS.
≤ 2 years
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
unknown
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
unknown
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Update Notes
Updated recruitment status.
6/25/2020
Moved to Ongoing, Not Recruiting status Removed Primary Contact Removed Calgary Location All Locations moved to not recruiting status
3/26/2020
Montreal Location now recruiting.
3/19/2020
No significant updates
1/30/2020
Updated recruitment status
1/23/2020
No significant updates
12/4/2019
updated recruitment status
10/18/2019
No significant updates
9/18/2019
No significant updates.
7/31/2019
No significant updates
7/1/2019
No significant updates
7/1/2019
Trial added
6/12/2019

Other Information

Purpose
Single ascending doses of AP-101 will be administered by intravenous (IV) infusion
Eligibility
18 Years and older, all genders, not accepting healthy volunteers
Details
Collaborator(s)
    -
News Articles and Summaries
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ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT03981536 (First Published: 6/11/2019)