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Open-label Trial of IVIG in Children With PANS

NCT04609761 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-03-06

No results posted yet for this study

Summary

Open-label prospective trial to study efficacy, safety and tolerability of intravenous immunoglobulin (IVIG) once monthly for 6 months in children and adolescents with PANS. Number of subjects: 10. Age range: 4-17 years.

Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) is a recently defined research diagnosis describing an abrupt, dramatic onset of neuropsychiatric symptoms including obsessions/compulsions and/or food restriction in children. Immunologic mechanisms are suspected, but treatment trials are few.

Conditions

  • PANS Pediatric Acute-Onset Neuropsychiatric Syndrome

Interventions

DRUG

Privigen Injectable Product (Intravenous Immunoglobulin)

Privigen, 2 g/kg BW every 4th week for 6 months (= 6 infusions).

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Christopher Gillberg, Professor · Gillberg Neuropsychiatry, Centre Sahlgrenska Academy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-12
Primary Completion
2025-10-15
Completion
2025-10-15

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04609761 on ClinicalTrials.gov