The ProPANS IVIG Clinical Trial is a clinical trial for children between 6 years -17 years of age who have moderate to severe pediatric acute-onset neuropsychiatric syndrome (PANS/PANDAS). Clinical trial participation lasts about 6 months. All participants will receive the study drug (Panzyga) and placebo (no active ingredients) during the clinical trial. The infusion visits span over 18 weeks and the clinical trial is divided into two 9 week periods. Participants are randomly assigned to receive Panzyga in either the first or second half of the clinical trial.
Clinical trial participants may be able to join if they meet the following requirements:
- Between the ages of 6 years – 17 years
- Onset of initial PANS/PANDAS symptoms was not more than 12 months prior to first study drug infusion. Or, for children with relapsing symptoms, the initial symptoms were less than 24 months prior to first treatment or an absence of significant improvement and stabilization.
- Moderate to severe PANS/PANDAS with prominent and stable obsessive-compulsive disorder (OCD) 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).
Other clinical trial requirements will apply
Take Pre-screenerParticipation in the ProPANS IVIG clinical trial lasts about 22 weeks. Clinical trial participants can expect the following:
- Informed Consent: Review & sign the Informed Consent Form.
- Screening (up to 4 weeks): Receive health assessments to confirm if your child qualifies for the clinical trial.
- Clinical trial treatment period (18 weeks): Patients will visit the clinic 6 times in three weeks intervals to receive either the study drug or placebo (1:1 randomization).
- Follow-up Period (week 22): Receive health assessment and evaluations.
Participation in a clinical trial is voluntary. You can ask any questions you have and may leave the clinical trial at any time, for any reason.
