A Superiority Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS)
Phase: PHASE3
Conditions: Pediatric Acute-Onset Neuropsychiatric Syndrome
Sponsor: Octapharma

 
Clinical Study Protocol 
Version: 6.0 
Date: 21-July-2023 
 
 
NCT Number: NCT04508530 
 
Title: A Superiority Phase 3 Study to Compare the Effect of Panzyga Versus Placebo in Patients 
with Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS/PANDAS) 
 
Study Number: NGAM-13 
 
 
This document may include redaction of names, addresses, and other personally identifiable 
information, as well as redaction of trade secrets and/or confidential commercial information. 

Property of Octapharma. Do not copy or distribute without written permission.
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2 g/kg
2 g/kg
2 g/kg
placebo
placebo
placebo
PANS 
diagnosis
Panzyga
Placebo
Baseline
W3
W6
W9 Primary 
endpoint 
evaluation
Behavioral evaluations
1:1
Randomization
Screening
-28 Days
1st double-blind treatment period
9 weeks
1 g/kg/day on 2 consecutive days
2
p
Volume equal to 2 g/kg Panzyga
over 2 consecutive days
(completed 
antibiotic 
treatment per 
SoC if needed)
2
p
2nd double-blind treatment period
9 weeks
2 g/kg
2 g/kg
2 g/kg
2
2
W18
placebo
placebo
placebo
p
Volume equal to 2 g/kg Panzyga
over 2 consecutive days
p
W12
W15
2
o
2 
p
2
1 g/kg/day on 2 consecutive days

Property of Octapharma. Do not copy or distribute without written permission.
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