IVIG Study Recruiting within the next few months with Octafarma.
Octapharma has launched a phase 3, multicenter superiority study to compare the effectiveness of PANZYGA® (immune globulin intravenous, human – ifas) 10% Liquid Preparation versus placebo in patients with pediatric acute-onset neuropsychiatric syndrome (PANS).
Please note that recruitment for this trial is scheduled to begin in early 2021, pandemic permitting. As you will see, one of the recruitment criteria is limited to recent onset PANS patients.
“Researchers aim to enroll 92 patients from age 6 to 17 with a confirmed diagnosis of moderate to severe PANS. Approximately 30 study sites are planned for the prospective, randomized, double-blind, parallel group, placebo-controlled superiority study. The primary objective of the trial is to evaluate if PANZYGA® is superior to placebo (0.9% w/v sodium chloride) for reducing the severity of symptoms associated with PANS in pediatric patients. The secondary objectives of this study are to determine the sustainability of the reduction of the severity of symptoms in pediatric patients treated with PANZYGA®; and to assess the efficacy of PANZYGA® treatment in reducing functional impairment associated with PANS.” – Official Octapharma PANS IVIG Trial Press Release: Octapharma Launches Phase 3 Superiority Study for Pediatric Acute-onset Neuropsychiatric Syndrome
Full Eligibility Criteria is published at the following link at NIH Clinical Trials.
- Confirmed PANS PANDAS diagnosis
- Ages 6-17
- Onset of symptoms within the last 6months or PANDAS cases with relapsing remitting onset in the last 12 months.
- Exclusions include patients with autism and other co-morbid conditions
Questions should be directed to the contact information included in the Clinical Trials website and on the Press Release (both are linked within this article).