A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychi… (NCT03348618) | Clinical Trial Compass
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 range
4 Years – 16 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)
3
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)
4
Change in Clinical Global Impressions (CGI)
Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)
5
Change in biomarkers levels
Timeframe: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)