Quick Info
Status
Not Yet 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
Locations
Department of Clinical Neurosciences University of Calgary, Calgary
Kaye Edmonton Clinic, University of Alberta , Edmonton
London Health Sciences Centre, University Hospital, London
Sunnybrook Health Sciences Centre, Toronto , Toronto
Montreal Neurological Institute & Hospital , Montreal
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
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)