A superiority phase III study to compare the effect of Panzyga versus placebo in patients with pediatric acute-onset neuropsychiatric syndrome
This research is looking into a condition called Pediatric Acute-onset Neuropsychiatric Syndrome (PANS). PANS can cause children to have sudden and sometimes severe changes in their behaviour and thinking. This study aims to find out if a medicine called Panzyga is better than a placebo (a dummy treatment without active medicine) at helping children with PANS feel better. We will be carefully checking their symptoms and how they behave over several weeks to see if Panzyga leads to significant improvements. The study is particularly interested in how long any benefits from Panzyga might last. This is a Phase III study, which means it's one of the final steps before a medicine might be considered for wider use.
At a glance
What is this study about?
This study is about a condition called Pediatric Acute-onset Neuropsychiatric Syndrome, or PANS for short. PANS is a serious condition where children suddenly develop obsessive-compulsive disorder (OCD) symptoms, tics, or other behavioural and emotional issues. These changes can happen very quickly, often after an infection like strep throat, and can be quite distressing for both the child and their family. We are trying to find a better way to help children with PANS.
The main goal of this study is to see if a treatment called Panzyga can help improve the symptoms of PANS. Panzyga is given directly into a vein using a drip. We will compare Panzyga with a placebo, which looks exactly like Panzyga but doesn't contain any active medicine. This comparison helps us understand if any improvements seen are truly due to Panzyga or if they might have happened anyway. We will be carefully looking at how children’s brain-related symptoms and behaviour change over time.
Researchers will use a special scoring system to measure these changes, especially looking at how much symptoms improve over the first nine weeks. We'll also pay attention to how long these improvements last after the main treatment period, up to 18 weeks. By doing this, we hope to learn if Panzyga is a safe and effective treatment that can make a real difference for children suffering from PANS.
Key takeaways
- This study evaluates Panzyga for children with PANS.
- It compares Panzyga to a placebo (dummy treatment).
- The main aim is to see if Panzyga improves PANS symptoms and behaviour.
- Children will have regular assessments over 18 weeks.
- Both boys and girls with a PANS diagnosis can participate.
Who may be eligible?
This study is for children and young people diagnosed with Pediatric Acute-onset Neuropsychiatric Syndrome (PANS). Both boys and girls can take part, regardless of their age.
To be considered for this study, your child must have received a formal diagnosis of PANS. The clinical team will review your child's medical history and current health to ensure they meet all the specific requirements for participation and that it's safe for them to take part.
There might be other detailed health requirements or medical conditions that would prevent someone from joining, which the study team will discuss with you. It's important to have an open conversation with the study doctors to find out if this study is suitable for your child.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my child diagnosed with Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)?
- Is my child currently experiencing symptoms of PANS?
- Am I comfortable with my child potentially receiving a placebo?
- Can my child attend regular clinic visits and assessments for 18 weeks?
- Are there any other serious health conditions my child has?
What does participation involve?
If your child takes part in this study, they will receive either Panzyga or a placebo through a drip (intravenous infusion). You won't know whether your child is getting the active medicine or the placebo. This is to ensure the results are as fair and unbiased as possible. Over the course of the study, your child will have several visits to the clinic.
During these visits, healthcare professionals will carry out various assessments. This includes using special questionnaires and scales, like the CY-BOCS, to measure changes in your child's symptoms and behaviour. They will also use other tools to check for tics and overall wellbeing. These assessments will happen regularly for up to 9 weeks, and then again at 18 weeks to see how long any benefits last.
The total duration of your child's involvement in the study, including all treatments and follow-up checks, will be around 18 weeks.
Potential risks and benefits
Locations (2)
- —UnverifiedSweden
- —UnverifiedItaly
Common questions
What is PANS?
PANS stands for Pediatric Acute-onset Neuropsychiatric Syndrome. It's a condition where children suddenly develop severe OCD symptoms, tics, or other behavioural issues.
What is Panzyga?
Panzyga is a medicine given into a vein. In this study, we're testing if it can help improve PANS symptoms.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps us compare the real medicine's effects.
Who can join this study?
Children and young people of any age, both boys and girls, who have been diagnosed with PANS, may be able to join.
How long does the study last?
Your child's involvement, including treatment and follow-up, will last for about 18 weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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