Ongoing Clinical Trials for Paediatric Acute-Onset Neuropsychiatric Syndrome
There is currently 1 ongoing clinical trial exploring treatment options for children with Paediatric Acute-Onset Neuropsychiatric Syndrome (Also known as: PANS). This trial is investigating whether an intravenous immunoglobulin therapy can help reduce the sudden and severe neuropsychiatric symptoms that characterize this condition, including obsessive-compulsive behaviors, anxiety, and mood changes.
Clinical trial locations
- Italy
- Sweden
Study Comparing Human Normal Immunoglobulin and Placebo for Children with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)
This clinical trial is being conducted in Sweden and Italy to evaluate whether Panzyga, a solution containing human normal immunoglobulin, can effectively treat children suffering from this challenging condition. The study compares Panzyga to a placebo to determine if it provides better symptom relief.
Who can participate:
- Children between 6 and 17 years old with a confirmed diagnosis of moderate to severe PANS
- Patients must have noticeable and stable obsessive-compulsive disorder symptoms, rated 4 or higher on a specific scale
- The condition must have started suddenly and dramatically, confirmed by diagnostic criteria
- Patients must have at least two additional sudden and severe neuropsychiatric symptoms from categories including anxiety (especially separation anxiety), extreme mood swings or depression, irritability and aggression, behavioral regression (acting younger than their age), decline in school performance, sensory or motor abnormalities, or physical symptoms like sleep problems or frequent urination
- Parents or legal guardians must provide informed consent, and the child should also agree if old enough to understand
- For patients with PANDAS (a related condition triggered by streptococcal infection), symptoms must show an episodic pattern and be linked to group A streptococcal infection
Who cannot participate:
- Patients with known allergies or severe reactions to the study medication or its ingredients
- Those with certain medical conditions that might interfere with study results
- Patients currently participating in another clinical trial
- Those who have recently received certain treatments or medications that could affect outcomes
- Patients with a history of substance abuse or dependency
- Those unable to comply with study procedures or follow-up visits
- Patients with any other condition that study doctors believe would make participation unsafe
What the trial involves:
The main goal of this study is to determine whether Panzyga is more effective than a placebo in reducing the severity of symptoms associated with PANS. Panzyga is an intravenous immunoglobulin therapy, meaning it contains antibodies derived from blood that help support the immune system. It works by modulating the immune system, though the exact mechanism is not fully understood.
Participants will receive either Panzyga or a placebo (0.9% sodium chloride solution) through an intravenous infusion directly into a vein. The study follows a structured timeline over 18 weeks:
- Joining the study: Eligibility is confirmed, and informed consent is obtained from parents or guardians
- Initial assessment: A baseline measurement of symptoms is established using the CY-BOCS score, which measures obsessive-compulsive symptom severity
- Treatment phase: Panzyga or placebo is administered intravenously over several weeks
- Monitoring: Throughout the study, symptoms are monitored using various scales including the Clinical Global Impression and the Parent & Child OC Impact Scale
- End of treatment assessment: At Week 9, changes in symptoms are evaluated to measure treatment effectiveness
- Follow-up period: The study continues until Week 18 to assess whether the clinical benefits of Panzyga treatment last over time
The primary measure of success is improvement in neuropsychiatric symptoms, specifically changes in the CY-BOCS score from the beginning of the study to Week 9. Healthcare professionals will carefully monitor participants throughout the study period to track their progress and ensure their safety.
Summary
Currently, there is one active clinical trial exploring treatment options for children with Paediatric Acute-Onset Neuropsychiatric Syndrome. This trial is being conducted in two European countries, Sweden and Italy, reflecting international collaboration in researching this challenging condition. The study focuses on testing Panzyga, an intravenous immunoglobulin therapy, as a potential treatment to reduce the sudden and severe neuropsychiatric symptoms that characterize PANS. The trial aims to provide valuable information about whether this immune-modulating therapy can offer meaningful relief for affected children and their families.