CompletedPhase 2

3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS)

Australia16 participantsStarted 2021-11-25

Plain-language summary

Phase 2 open label trial to investigate the safety and potentially efficacy of 3K3A-APC in patients with Amyotrophic Lateral Sclerosis (ALS).

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Current treatment with anticoagulants (e.g., warfarin, novel oral anticoagulants, heparin) that might preclude safe completion of the lumbar puncture
✕. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia
✕. Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10)
✕. Prolonged prothrombin time or activated partial thromboplastin time \>2xULN
✕. Severe hypertension or hypotension
✕. Glomerular filtration rate (GFR) \<35 mL/min
✕. Forced vital capacity (FVC) at screening of \<50% of predicted
✕. Prior exposure to any exogenous form of APC

Number of Participants Who Had Any Serious Adverse Events or Any Adverse Events With Severity Higher Than "Moderate".

Timeframe: 15 Days

Percentage of Change in PERSI Score in the Motor Cortex Before and After Dosing

Timeframe: 7 Days

NCT IDNCT05039268

SponsorMacquarie University, Australia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-12

Results submitted2023-09-21

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Current treatment with anticoagulants (e.g., warfarin, novel oral anticoagulants, heparin) that might preclude safe completion of the lumbar puncture
✕. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia
✕. Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10)
✕. Prolonged prothrombin time or activated partial thromboplastin time \>2xULN
✕. Severe hypertension or hypotension
✕. Glomerular filtration rate (GFR) \<35 mL/min
✕. Forced vital capacity (FVC) at screening of \<50% of predicted
✕. Prior exposure to any exogenous form of APC