For Healthcare Professionals

NOTE: Information on this webpage is applicable to Healthcare Professionals (HCPs) only.

The ProPANS IVIG clinical trial is sponsored by Octapharma AG. This clinical trial is a superiority Phase III study to compare the effect of Panzyga versus placebo in patients with pediatric acute-onset neuropsychiatric syndrome. This is a global study; current study locations include the United States, Italy, and Sweden.

Primary study objective

To study the improvement of neuropsychiatric symptomatology and behavior in PANS patients determined by clinician-rated Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) score. The mean changes in the total CY-BOCS score from Baseline to Week 9 will be compared between Panzyga and placebo treatment to demonstrate superiority. The CY-BOCS scale score is a clinician-rated, semi-structured interview for rating the presence or absence, as well as the severity of obsessive-compulsive symptoms. The CY-BOCS yields a total obsession score, a total compulsion score and combined total score (maximum total CY-BOCS score=40).

Inclusion/Exclusion criteria

I/E criteria is based on protocol version 6

Inclusion Criteria:
  1. Abrupt dramatic onset of OCD meeting DSM-5 diagnostic criteria for OCD as confirmed by the MINI-KID-7
  2. Concurrent presence of additional neuropsychiatric symptoms, with similarly severe and acute onset, from at least two of the following seven categories, that are not better explained by a known neurologic or medical disorder, such as Sydenham chorea (SC), systemic lupus erythematosus, Tourette disorder, or other:
Patients who will additionally meet the following optional inclusion criteria will be identified as patients with Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS):
Exclusion Criteria:
  1. History of severe hypersensitivity, e.g., anaphylaxis or severe systemic response, to immunoglobulin, blood or plasma derived products, or any component of Panzyga.
  2. Immunoglobulin (Ig) A deficiency with antibodies to IgA (<7 mg/dL).
  3. Hyperviscosity syndromes or known or suspected hypercoagulable conditions as inferred from clinical history, which can increase risks of thrombosis associated with IVIG administration.
  4. History of arterial or venous thrombotic or thromboembolic events (TEEs) within the last year prior to Baseline. History of acquired or inherited thrombophilia any time prior to Baseline.
  5. Need for live virus vaccine within three months after receiving study drug.
  6. Renal dysfunction (creatinine >120 µmol/L or 1.36 mg/dL), history of renal dysfunction, or known risk factor for renal dysfunction (chronic renal insufficiency, diabetes mellitus, taking known nephrotoxic medication).

Click the email or phone link below if you would like more information on the trial, have a patient you would like to refer, or are interested in becoming a study site:

For additional information about the ProPANS IVIG clinical trial: