What side effects are associated with this type of intervention?

Intravenous immunoglobulin (IVIG) therapy, used to modulate the immune system in conditions like Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS), can have several side effects. Common side effects include headaches, chills, fever, fatigue, nausea, and muscle aches. More serious but less common side effects can include allergic reactions, kidney dysfunction, blood clots, and aseptic meningitis. It is important for patients to be monitored closely by their healthcare provider during and after treatment to manage any adverse effects.

What prior FDA approvals exist?

Intravenous immunoglobulin (IVIG) has been used in various neuropsychiatric and autoimmune conditions, including Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) and Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS). While specific FDA approvals for IVIG in these conditions are limited, IVIG is commonly used off-label to modulate the immune system and reduce inflammation. Panzyga, a form of IVIG, is currently being studied for its efficacy in treating these syndromes. Other related treatments include immunomodulatory therapies such as corticosteroids and plasmapheresis, which also aim to reduce autoimmune activity and inflammation.

What other types of research exist?

Promising alternatives to Panzyga for Pediatric Neuropsychiatric Syndrome patients include Rituximab, which has shown beneficial effects in autoimmune conditions, and high-dose corticosteroids, which are used to reduce inflammation and modulate the immune response. Additionally, emerging therapies such as biologics targeting specific immune pathways (e.g., TNF-α inhibitors) and other immunosuppressive agents like mycophenolate mofetil may also be considered.

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Immunoglobulin

Panzyga for Pediatric Neuropsychiatric Syndrome

Phase 3

Waitlist Available

Research Sponsored by Octapharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Behavioral (developmental) regression (examples, talking baby talk,throwing temper tantrums, etc.)

Sensory or motor abnormalities

Must not have

- History of rheumatic fever, including SC (neurological manifestation).

- Cardiac insufficiency (New York Heart Association [NYHA] classification III-IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing Panzyga, a medication that boosts the immune system. It targets children with Pediatric Acute-onset Neuropsychiatric Syndrome (PANS), a condition causing sudden severe psychiatric symptoms. Panzyga works by providing antibodies to help fight infections and reduce inflammation, potentially improving these symptoms.

Who is the study for?

Children aged 6 to 17 with moderate to severe Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) and obsessive-compulsive disorder (OCD) symptoms. They must have had a recent streptococcal infection and show other neuropsychiatric symptoms like mood swings, aggression, or motor abnormalities. Legal guardians must consent, and kids should assent if able.

What is being tested?

The trial is testing Panzyga against a placebo in children with PANS/PANDAS to see which is more effective. Panzyga is an immunoglobulin therapy thought to help reduce the syndrome's severity by modulating the immune system.

What are the potential side effects?

Panzyga may cause side effects such as allergic reactions, headache, fever, nausea, vomiting, muscle pain. It can also potentially lead to more serious issues like blood clots or kidney problems in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have shown signs of acting younger than my age, like baby talk.

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I experience unusual sensations or have trouble moving parts of my body.

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I have been diagnosed with OCD that started suddenly.

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I experience extreme mood swings or depression.

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I experience significant irritability, aggression, or oppositional behaviors.

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I am between 6 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had rheumatic fever in the past.

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I do not have severe heart problems like heart failure or irregular heartbeats needing treatment.

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I have been treated for mental health symptoms with specific immune therapies or a blood purification process.

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I have a history of hepatitis B, C, or HIV.

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I cannot receive IVIG due to health reasons.

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I am a woman who can have children and agree to use birth control as required by the study.

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I haven't started or changed SSRIs dosage in the last 8 weeks.

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I have had blood clots or inherited clotting disorders.

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My liver is severely damaged, with ALT levels three times above normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CY-BOCS score - Primary

Secondary study objectives

CY-BOCS score - Secondary

Child OC Impact Scale

Clinical Global Impression

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PanzygaExperimental Treatment1 Intervention

Panzyga 10% IVIG

Group II: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panzyga

2011

Completed Phase 3

~420

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intravenous immunoglobulin (IVIG) is a common treatment for Pediatric Neuropsychiatric Syndrome (PANS/PANDAS) that works by modulating the immune system to reduce inflammation and autoimmunity. This is crucial for PANS/PANDAS patients because these conditions are often triggered by autoimmune responses following infections, such as streptococcal infections. By modulating the immune response, IVIG can help alleviate the neuropsychiatric symptoms associated with these syndromes, improving the quality of life for affected children.

[Intravenous immunoglobulin in the treatment of malignant epilepsy in children].Intravenous Immunoglobulin as a Therapeutic Option for Mycoplasma pneumoniae Encephalitis.[Intravenous immunoglobulin in treatment of autoimmune neurological diseases in children].