A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)

IMMUNOe Research Centers21 enrolled

Overview

This study will evaluate the use of intravenous immunoglobulins (IVIG) at a dose of 1g/Kg/body weight given every three weeks for 6 infusions in pediatric subjects ages 4 - 16 years with moderate to severe PANS. The study will compare biomarkers and behavioral scales before treatment, after the last infusion, 2 months, and at a minimum 6 months post-treatment.

IVIG at an immunomodulatory dose of 1 g/Kg body weight has been known to induce suppression of systemic inflammation and has been used in the treatment of autoimmune diseases. It has been proven beneficial in inflammatory conditions affecting the nervous system.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pediatric Acute-Onset Neuropsychiatric Syndrome Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections

Interventions

IVIGBIOLOGICAL

Intravenous immunoglobulin

Eligibility

Sex: ALLMin age: 4 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female children, 4-16 years of age * Diagnosis of moderate to severe PANS based on accepted criteria * Must be willing to follow study procedures and comply with wash-out period * If using prophylactic antibiotics, must be on stable dose for 3 months Exclusion Criteria: * History of rheumatic fever, including Sydenham chorea (the neurologic manifestation) * Previous IVIG therapy within the last 6 months * Allergic reactions to blood products * Patients who, in the investigator's opinion, might not be suitable for the trial. * Steroid use

Locations (3)

IMMUNOe Research Centers

Centennial, Colorado, United States

Midwest Pediatrics

Papillion, Nebraska, United States

Allergy, Asthma & Immunology Relief Research Institute

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Change in Anxiety Disorders Interview Schedule for DSM-IV, Child, Parent Versions (ADIS)

ADIS Child and Parent Interviews are designed to diagnose children with emotional disorder, where anxiety is a prominent component. Problem behaviors and diagnoses include school refusal behavior, separation anxiety, social phobia, specific phobia, panic disorder, agoraphobia, OCD and PTSD. Assessment of ADHD allows for differentiation of inattentive type, hyperactive-type, and combined type.