Intravenous immunoglobulin (IVIG) treatment in children with Pediatric Acute-onset Neuropsychiatric Syndrome (PANS): an open-label trial in South-western Sweden - IVIGPANSOpen

Gillberg Neuropsychiatry Centre0 sites10 target enrollmentJanuary 13, 2020

Overview

No summary available.

Registry

who.int

Start Date

January 13, 2020

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Gillberg Neuropsychiatry Centre

•1\. The subject and parents/caregivers have given written consent or assent to participate
•in the study.
•2\. Children and adolescents between the ages of 4 and 17 years at Baseline.
•3\. Documented and confirmed pre\-existing diagnosis of post\-infectious PANS/PANDAS
•4\. The subject has not been treated with IVIG previously or not been treated for the last 6
•5\. If the patient is on long\-term antibiotic prophylaxis, this should be unchanged one month
•before baseline and during the trial.
•6\. Infections occurring during the trial should be treated according to standard clinical
•7\. Treatment with COX\-inhibitors or corticosteroids should be discontinued at least one
•month before baseline and during the trial. Two\-three days treatment with corticosteroids

•1\.Clinical evidence of any significant acute or chronic disease that, in the opinion of the
•Investigator, may interfere with successful completion of the trial or place the subject at
•undue medical risk. Spinal tap results are required before study start to rule out
•encephalitis (which would need to be treated according to encephalitis treatment
•guidelines).
•2\. The subject has had a known serious adverse reaction to immunoglobulin or any severe
•anaphylactic reaction to blood or any blood\-derived product
•3\. Females of childbearing potential who are pregnant, have a positive pregnancy test at
•Baseline (human chorionic gonadotropin \[HCG]\-based assay), are breastfeeding, or
•unwilling to practice a highly effective method of contraception (oral, injectable or