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

IMMUNOe Research Centers

Status and phase

Unknown

Phase 4

Conditions

Pediatric Acute-Onset Neuropsychiatric Syndrome

Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections

Treatments

Biological: IVIG

Study type

Interventional

Funder types

Industry

Identifiers

NCT03348618

IIS201701-PANS

Details and patient eligibility

About

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.

Full description

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.

Enrollment

21 estimated patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

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