A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
Status unconfirmed · Phase 4
Conditions studied: Pediatric Acute-Onset Neuropsychiatric Syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections
In brief
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.
Key facts
- Study ID
- NCT03348618
- Run by
- IMMUNOe Research Centers
- People needed
- 21
- Starts
- 2017-11-24
- Expected to finish
- 2020-03-01
- Last updated by the study team
- 2019-11-19
Who can join
Age: 4 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- IMMUNOe Research Centers — Centennial, Colorado, United States
- Midwest Pediatrics — Papillion, Nebraska, United States
- Allergy, Asthma & Immunology Relief Research Institute — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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