Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT04609761
Brief 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.
Detailed Description:
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 (including the subgroup PANDAS). 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.
The primary objective of this study is to evaluate the efficacy of intravenous immunoglobulin (IVIG), 2 g/kg given every 4 weeks for 6 months, to patients with post-infectious PANS/PANDAS, in improving neuropsychiatric symptoms and impairment.
The secondary objectives of this study are to evaluate changes from baseline to follow-up at 3 months, 6 months and 12 months in:
* Obsessive Compulsive Disorder (OCD) symptoms
* adaptive functioning
* quality of life
* cognitive functioning
* for patients with baseline inflammation signs on cerebral Magnetic Resonance Imaging (MRI) to evaluate changes in these measures after IVIG therapy after 6 months.
* number of days of work/school/daily activities missed per subject year due to PANS/PANDAS before and after IVIG therapy
* parental care load, e.g. need for sick leave, before and after IVIG therapy
* Immunoglobulin (IgG, IgM and IgA) levels at baseline, 3 months, 6 months and 12 months
* sustainability of any improvement at 12 months after initiation of IVIG measured with the PANS scale, CGI-S and CGI-I
To assess the safety and tolerability of high dose IVIG therapy
* Clinical signs and symptoms (nausea, headache, local reactions)
* ALAT
* Hemoglobin, complete blood count including leucocyte differential
Investigational product: Intravenous immunoglobulin IVIG (Privigen), 2 g/kg BW every 4th week for 6 months (= 6 infusions).
Study:
NCT04609761
Study Brief:
Protocol Section:
NCT04609761