Status:
UNKNOWN
A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
Lead Sponsor:
IMMUNOe Research Centers
Collaborating Sponsors:
Octapharma
Conditions:
Pediatric Acute-Onset Neuropsychiatric Syndrome
Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections
Eligibility:
All Genders
4-16 years
Phase:
PHASE4
Brief 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 s...
Detailed 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 benef...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03348618
Start Date
November 24 2017
End Date
March 1 2020
Last Update
November 19 2019
Active Locations (3)
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1
IMMUNOe Research Centers
Centennial, Colorado, United States, 80112
2
Midwest Pediatrics
Papillion, Nebraska, United States, 68046
3
Allergy, Asthma & Immunology Relief Research Institute
Charlotte, North Carolina, United States, 28204