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PANS/PANDAS IVIG STUDY ENROLLING

If your patient was recently diagnosed with moderate to severe PANS (Pediatric Acute-onset Neuropsychiatric Syndrome) / PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections), they may qualify to participate in a study to determine the sustainability of the reduction of the severity of symptoms in children treated with intravenous human normal immunoglobulin and to assess its efficacy in reducing functional impairment associated with PANS/PANDAS.

This is a randomised, double-blind, placebo-controlled superiority study spanning about 6 months. Study-related travel expenses are provided for the 8 study clinic visits.

ELIGIBILITY SNAPSHOT

6-17 years in age

Onset of initial PANS/PANDAS symptoms was not more than 6 months prior to planned Screening. Or, for children with relapsing symptoms, the initial symptoms were less than 12 months prior to Screening and recurrence is within 6 months of Screening

Moderate to severe PANS/PANDAS with prominent and stable obsessive-compulsive disorder symptoms

Do not have symptoms consistent with autism, schizophrenia, bipolar disorder, or any other psychotic disorder (unless psychotic symptoms have onset coincident with PANS/PANDAS).

For the full list of criteria and exclusions, please visit the clinical trial page. (Identifier: NCT04508530)

For more information about enrollment, please contact:

Snehal Udavat
Clinical operations at Octapharma USA, Inc.
201-604-1124
snehal.udavat@octapharma.com

ABOUT CLINICAL RESEARCH

Clinical research studies rely on volunteer participants to find out if a new, investigational drug is safe and possibly improves people’s health. Participating in the ProPANS study may help the development of a new PANS/PANDAS therapy in the future. An investigational drug refers to a medicine being studied in clinical research studies. Investigational drugs usually go through 4 phases of testing.  ProPANS is a Phase 3 study.

Phase 1: First study of the drug in (usually) healthy people

Phase 2: Study of the drug in people with the condition the drug is designed to improve

Phase 3: Study of the drug to confirm how safe and effective it is for improving the condition

Phase 4: More research after the drug is approved for the public