A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)

A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)

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:
AL-S Pharma
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
≥60% SVC
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
≤ 2 years
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
unknown
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
unknown
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Yes

Update Notes:

6/12/2019Trial added

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

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:
ALS Forum:
First Published on Clinicaltrials.gov: 6/11/2019
ClinicalTrials.gov ID: NCT03981536
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov