A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 4 - 16 |
| Updated: | 3/7/2019 |
| Start Date: | November 24, 2017 |
| End Date: | March 2020 |
A Multi-site, Open-Label, Pilot Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
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.
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.
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.
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
We found this trial at
3
sites
Papillion, Nebraska 68046
Principal Investigator: Roger Kobayashi, MD
Phone: 402-592-1700
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Centennial, Colorado 80112
Principal Investigator: Isaac Melamed, MD
Phone: 303-224-4701
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Charlotte, North Carolina 28204
Principal Investigator: Maeve O'Connor, MD
Phone: 704-910-1402
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