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).
Gabriella True
7 comments to IVIG for PANS PANDAS Study
Ahmed Salah
September 4, 2020i have a 6 year old with Pandas.
hris
October 22, 2020thanks for this info
Michelle A Mooers
November 25, 2020I have son age 14 current lyme ,chronic
asd, pans/pandas and duaghter age 9 pans/pandas, mitochondrial disorder, pituitary disfunction.
If could find any help for them, i will take them anywhere. Currently out of pocket seeing 1 functional, integrated med peds. Dr is new york, we are southern California. Zero drs here know or believe pans/pandas is a real dx,and treat kids as such. Ditto for the school. I have watched both my kids disappear infront of me. Took longer for my daughter, most likely due to myself being dx with celiac disease, going GF slowed her progression. But not by much, sons onset was at 3 n half, hers was at 6, and getting worse. We do labs every 6 to 8 weeks,have tried every antibiotics for over year now. Any further treatment cannot be done unless we move. Which i am trying to do. Standford is closer than newyork. I am sure there are plenty of parents and families trying to find help same as I.
Gabriella True
December 1, 2020Dr. Hirani treats Lyme in Culver City. http://aspire.care/treating-pans/find-a-provider/
Stephanie
December 4, 2020Is there any trials in Washington State?
Esther copeland
February 12, 2021How do we apply for this study? I have had several drs say my son would benefit from ivig but noone has been able to do it
Gabriella True
February 12, 2021Please click on the link provided in this post and it will take you to the NIH clinical trials page where there is more information. They are not yet recruiting.