PANS/PANDAS IVIG STUDY
Did your child or patient recently start showing Pediatric
Acute-Onset Neuropsychiatric Syndrome
(PANS/PANDAS) symptoms?
They may qualify for an IVIg study that will look at how well an IVIG study drug may work for children 6 years-17 years of age
who have PANS/PANDAS. Help with study-related travel expenses will be provided.
ELIGIBILITY SNAPSHOT
✓ 6-17 years in age
✓ Onset of initial PANS/PANDAS episode must not be more than seven months prior to first investigational medicinal product treatment. In patients with relapsing episodes, initial episode may not have been more than 12 months prior to Screening, must have fully resolved based on investigator’s judgment, and the recurrence must be less than six months prior to 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)
LOCATIONS
Arizona, Arkansas, California, Colorado, Massachusetts, New Hampshire, and Sweden.
Help with study-related travel expenses will be provided.
CONTACT
For more information about the ProPANS study or to see if your child or patient may qualify:
Email: PANStrial@octapharma.com
Phone: 888 885 4598
STUDY DETAILS
Study length
- About 6 months
- Involves 8 visits (about 3 weeks apart) to a study clinic
Study drug
- All participants receive the study drug for 9 weeks and then placebo for 9 weeks, or vice versa
- Study drug and placebo are given as an IV infusion (each infusion lasts about 3 hours)
- The study drug has been FDA approved for other conditions, but not yet for PAN
Participant responsibilities
- Visit the study clinic every 3 weeks for 18 weeks to receive IV infusions of the study drug or placebo
- Note: Each visit lasts for 2 consecutive days. Your child will receive an IV infusion each day
- Complete all follow-up visits
- Follow instructions from the study doctor and team
- Alert the study doctor and team right away if you experience any new symptoms or have symptom changes