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Panzyga for Pediatric Neuropsychiatric Syndrome
Study Summary
This trial is testing whether Panzyga is better than placebo at treating pediatric acute-onset neuropsychiatric syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with severe PANS and OCD.I haven't started or changed ADHD medication doses in the last 4 weeks.I experience separation anxiety.I have had rheumatic fever in the past.I haven't taken any corticosteroids in the last 8 weeks.I haven't taken alpha-2 agonists or antipsychotics in the last 8 weeks.I do not have severe heart problems like heart failure or irregular heartbeats needing treatment.I have severe sudden symptoms in at least two different mental health areas not caused by another known condition.My symptoms come and go in episodes.I have a condition that affects how my body uses proteins or antibodies.I have shown signs of acting younger than my age, like baby talk.I haven't taken antibiotics or antivirals at treatment doses in the last week.My first PANS episode was over 7 months ago, or I had a relapse less than 6 months ago.I have kidney problems or factors that could cause them, like diabetes or taking certain medications.I have been treated for mental health symptoms with specific immune therapies or a blood purification process.I started cognitive behavioral therapy less than 8 weeks ago.I have a history of hepatitis B, C, or HIV.My legal guardian understands and can follow the study's requirements.I experience unusual sensations or have trouble moving parts of my body.I cannot receive IVIG due to health reasons.I haven't used THC in the last 4 weeks but may use CBD/CBM without THC.I am a woman who can have children and agree to use birth control as required by the study.My symptoms started or got worse after a strep throat infection.I, or my legal guardian, have signed the consent form for this study.I have been diagnosed with OCD that started suddenly.I experience extreme mood swings or depression.I haven't started or changed SSRIs dosage in the last 8 weeks.I show symptoms of autism, schizophrenia, bipolar disorder, or another psychotic disorder.I experience significant irritability, aggression, or oppositional behaviors.I have had blood clots or inherited clotting disorders.My liver is severely damaged, with ALT levels three times above normal.I experience sleep problems, bed wetting, or need to urinate often.I will not need a live virus vaccine within three months after starting the study drug.I am between 6 and 17 years old.
- Group 1: Placebo
- Group 2: Panzyga
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
At how many distinct locations is this clinical trial taking place?
"7 study sites are participating in this clinical trial, they are based in cities including Palo Alto, Centennial, and Boston. If you are interested in participating, please select the location nearest to you to minimize travel."
Could you please share what sort of medical research has been conducted with Panzyga in the past?
"The first clinical trial for Panzyga was at Montefiore Medical Center in 2008. As of now, 18390 studies have been completed while 37 are still recruiting patients. The majority of these open trials are based in Palo Alto, Colorado."
What are some of the main reasons why Panzyga is given to patients?
"Panzyga can help patients with bruton's agammaglobulinemia, primary immunodeficiencies (pid), and agammaglobulinemia."
Does this trial have any age restrictions?
"This study is looking for participants who are above the age of 6 but have not yet reached their 18th birthday."
Are people currently being sought for this experimental treatment?
"That is correct. The clinical trial in question, which is currently looking for 92 participants, is active. 7 sites are listed on the most recent update hosted on clinicaltrials.gov, which was 10/17/2022. The trial was initially posted on 6/30/2021."
How many eligible individuals are being recruited for this research project?
"That is accurate. The information available on clinicaltrials.gov suggests that this particular clinical trial is still recruiting patients. The clinical trial was first posted on 6/30/2021 and was last edited on 10/17/2022. The clinical trial is looking to recruit 92 participants from 7 different sites."
Is there a margin of error for Panzyga's safety?
"Panzyga's safety is rated a 3 by our team at Power. This is due to the fact that Panzyga is in Phase 3 clinical trials, thus there is some evidence of efficacy as well as multiple rounds of data supporting safety."
Who is this clinical trial ideally suited for?
"This study is looking for 92 patients, within the ages of 6 and 17, who have polyarteritis nodosa and meet the following criteria: Anxiety (particularly, separation anxiety), Emotional lability (extreme mood swings) and/or depression, Deterioration in school performance, Sensory or motor abnormalities, Signed informed consent of patient's legal representative(s)/guardians(s). If patients are old enough to understand the risks and benefits of the study (as determined by each institution), they should provide written assent/consent., Abrupt dramatic onset of OCD meeting DSM-5 diagnostic criteria for OCD as confirmed"
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