UnknownPhase 4

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

United States21 participantsStarted 2017-11-24

Plain-language summary

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.

Who can participate

Age range4 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)

Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)

Change in Yale Global Tic Severity Scale (YGTSS)

Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)

Change in Clinical Global Impressions (CGI)

Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)

Change in biomarkers levels

Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)

Trial details

NCT IDNCT03348618

SponsorIMMUNOe Research Centers

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11

View on ClinicalTrials.gov More Pediatric Acute-Onset Neuropsychiatric Syndrome trials

Plain-language summary

Who can participate

Age range4 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)

Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)

Change in Yale Global Tic Severity Scale (YGTSS)

Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)

Change in Clinical Global Impressions (CGI)

Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)

Change in biomarkers levels

Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)