drugset / Trial / NCT04609761

Open-label Trial of IVIG in Children With PANS

NCT04609761

Phase 2 Completed 17 enrolled Göteborg University
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 2 g/kg Intravenous