AzTrials
AzTrials

PANS Pediatric Acute-Onset Neuropsychiatric SyndromePhase 2NCT04609761

Open-label Trial of IVIG in Children With PANS

A Phase 2 study testing Privigen Injectable Product (Intravenous Immunoglobulin) in people with PANS Pediatric Acute-Onset Neuropsychiatric Syndrome, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Open-label prospective trial to study efficacy, safety and tolerability of intravenous immunoglobulin (IVIG) once monthly for 6 months in children and adolescents with PANS. Number of subjects: 10. Age range: 4-17 years. Read more about this study

Who is it for?
Ages 4 to 17 years
What is being tested?
Privigen Injectable Product (Intravenous Immunoglobulin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteSweden
Study dates
12 Jan 2021to 15 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The subject and parents/caregivers have given written consent or assent to participate in the study.
  • Children and adolescents between the ages of 4 and 17 years at Baseline.
  • Documented and confirmed pre-existing diagnosis of post-infectious PANS/PANDAS
  • The subject has not been treated with IVIG previously or not been treated for the last 6 months
  • If the patient is on long-term antibiotic prophylaxis, this should be unchanged one month before baseline and during the trial. Throat culture for Group A Streptococcus (GAS) should be performed before study start and standard phenoxymethyl penicillin treatment given if positive culture.
  • Infections occurring during the trial should be treated according to standard clinical practice.
Show all 10Show fewer
  • Treatment with COX-inhibitors or corticosteroids should be discontinued at least one month before baseline and during the trial. Two-three days treatment with corticosteroids during and after IVIG treatment is allowed to reduce IVIG side effects such as headache and nausea.
  • Any psychopharmacological treatment (e.g. SSRI, antipsychotics), if considered essential for the subject, should be kept at a stable and unchanged dose from one month before baseline and during the trial. If not considered essential, it should be discontinued at least one month before baseline.
  • The medical records for all subjects should be available to document diagnosis, previous infections and treatment.
  • For female participants, adequate contraception should be used, see exclusion criteria. A negative pregnancy test can possibly be a requirement, specify requirement/type of pregnancy test. Contraceptive requirements may also apply to male participants.

Who cannot join

  • Clinical evidence of any significant acute or chronic disease that, in the opinion of the Investigator, may interfere with successful completion of the trial or place the subject at undue medical risk. If encephalitis cannot be excluded by clinical history alone, spinal tap results are required before study start to rule out encephalitis (which would need to be treated according to encephalitis treatment guidelines). MRI should have been performed if clinically indicated.
  • The subject has had a known serious adverse reaction to immunoglobulin or any severe anaphylactic reaction to blood or any blood-derived product
  • Females of childbearing potential who are pregnant, have a positive pregnancy test at Baseline (human chorionic gonadotropin [HCG]-based assay), are breastfeeding, or unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device [IUD] or intrauterine system [IUS], condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study Note: True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.)
  • The subject has significant proteinuria (dipstick proteinuria ≥ 3+, known urinary protein loss > 1 g/24 hours, or nephrotic syndrome), has a history of acute renal failure, has severe renal impairment (blood urea nitrogen [BUN] or creatinine more than 2.5 times the upper limit of normal [ULN]), and/or is on dialysis
  • The subject has Screening Visit values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding 2.5 times the ULN for the expected normal range for the testing laboratory.
  • The subject has hemoglobin < 90 g/L at Screening
Show all 17Show fewer
  • The subject has a known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • The subject has a history of or current diagnosis of deep venous thrombosis or thromboembolism (e.g., myocardial infarction, cerebrovascular accident, or transient ischemic attack); history refers to an incident in the year prior to Baseline or 2 episodes over lifetime.
  • The subject currently has a known hyperviscosity syndrome
  • The subject has an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1.0 x 109/L], or HIV infection/acquired immune deficiency syndrome (AIDS).
  • The subject is HIV positive by NAT based on a Screening blood sample.
  • The subject has non-controlled arterial hypertension at a level of greater than or equal to the 90th percentile blood pressure (either systolic or diastolic) for their age and height
  • The subject is receiving any of the following medications: (a) immunosuppressants including chemotherapeutic agents, (b) immunomodulators, (c) long-term systemic corticosteroids defined as daily dose > 1 mg of prednisone equivalent/kg/day for > 30 days. Note: Intermittent courses of corticosteroids of not more than 10 days would not exclude a subject. Inhaled or topical corticosteroids are allowed.
  • The subject has known substance or prescription drug abuse.
  • The subject has participated in another clinical trial within 30 days prior to Baseline (observational studies without investigative treatments [non-interventional] are permitted) or has received any investigational blood product within the previous 3 months
  • The subject/caregiver is unwilling to comply with any aspect of the protocol, including IV infusions, blood sampling
  • Mentally challenged subjects who cannot give independent informed consent In the opinion of the Investigator the subject may have compliance problems with the protocol and the procedures of the protocol.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Gillberg Neuropsychiatry Centre

    Gothenburg, 411 19

Other trials in Sweden

About this study

Official title: Intravenous Immunoglobulin (IVIG) Treatment in Children With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS): an Open-label Trial in South-western Sweden

Open-label prospective trial to study efficacy, safety and tolerability of intravenous immunoglobulin (IVIG) once monthly for 6 months in children and adolescents with PANS. Number of subjects: 10. Age range: 4-17 years.

Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) is a recently defined research diagnosis describing an abrupt, dramatic onset of neuropsychiatric symptoms including obsessions/compulsions and/or food restriction in children. Immunologic mechanisms are suspected, but treatment trials are few.

Read the detailed description

Open-label prospective trial to study efficacy, safety and tolerability of intravenous immunoglobulin (IVIG) once monthly for 6 months in children and adolescents with PANS (including the subgroup PANDAS). Number of subjects: 10. Age range: 4-17 years.

Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) is a recently defined research diagnosis describing an abrupt, dramatic onset of neuropsychiatric symptoms including obsessions/compulsions and/or food restriction in children. Immunologic mechanisms are suspected, but treatment trials are few.

The primary objective of this study is to evaluate the efficacy of intravenous immunoglobulin (IVIG), 2 g/kg given every 4 weeks for 6 months, to patients with post-infectious PANS/PANDAS, in improving neuropsychiatric symptoms and impairment.

The secondary objectives of this study are to evaluate changes from baseline to follow-up at 3 months, 6 months and 12 months in:

  • Obsessive Compulsive Disorder (OCD) symptoms
  • adaptive functioning
  • quality of life
  • cognitive functioning
  • for patients with baseline inflammation signs on cerebral Magnetic Resonance Imaging (MRI) to evaluate changes in these measures after IVIG therapy after 6 months.
  • number of days of work/school/daily activities missed per subject year due to PANS/PANDAS before and after IVIG therapy
  • parental care load, e.g. need for sick leave, before and after IVIG therapy
  • Immunoglobulin (IgG, IgM and IgA) levels at baseline, 3 months, 6 months and 12 months
  • sustainability of any improvement at 12 months after initiation of IVIG measured with the PANS scale, CGI-S and CGI-I

To assess the safety and tolerability of high dose IVIG therapy

  • Clinical signs and symptoms (nausea, headache, local reactions)
  • ALAT
  • Hemoglobin, complete blood count including leucocyte differential

Investigational product: Intravenous immunoglobulin IVIG (Privigen), 2 g/kg BW every 4th week for 6 months (= 6 infusions).

Being tested
Privigen Injectable Product (Intravenous Immunoglobulin)
Medical subject headings
Pediatric acute-onset neuropsychiatric syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Privigen Injectable Product (Intravenous Immunoglobulin)Drug

    Also called IVIG

    Privigen, 2 g/kg BW every 4th week for 6 months (= 6 infusions).

Study groups in NCT04609761
Study groupRoleWhat they receive
IVIG treatmentExperimentalSingle-arm open-label
Receives: Drug: Privigen Injectable Product (Intravenous Immunoglobulin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) scale symptoms and impairment

    Investigator-rated scale measuring symptom severity and impairment in Pediatric Acute-onset Neuropsychiatric Syndrome (PANS), score range 0-50, lower is better

    Measured: 6 months

  2. Change in CGI-S

    CGI-S (Clinical Global Impression-Severity) measures global symptom severity, score range 1-7, lower is better

    Measured: 6 months

  3. CGI-I

    CGI-I (Clinical Global Impression-Improvement) measures global improvement, score range 1-7, lower is better

    Measured: 6 months

Secondary outcomes (12)

  1. Change in CY-BOCS scale

    CY-BOCS scale measures Obsessive Compulsive Disorder (OCD) Symptoms, investigator-rated, score range 0-40, lower is better

    Measured: 6 months

  2. Change on ABAS (Adaptive Behavior Assessment System) II scale

    Measures level of functioning in everyday life, parent- and teacher-rated, score range 40-160, higher is better

    Measured: 6 months

  3. Change on Child Health Inventory (CHIP-CE) scale

    Measures quality of life, parent-rated, standardized T-score, mean 50, standard deviation 10, higher score is better

    Measured: 6 months

  4. Change on 5-15 scale

    Measures neuropsychiatric symptoms, score range 1-543, lower is better

    Measured: 6 months

  5. Change in neuromotor functioning

    Neuromotor examination by investigator

    Measured: 6 months

  6. Change in cognitive function

    Working memory test from Wechsler scale, standardized scores age norms, mean 100, standard deviation 10, higher is better

    Measured: 6 months

  7. Change in School-PANS (Pediatric Acute-onset Neuropsychiatric Syndrome) Scale

    Short version of PANS-scale rated by teacher or school assistant, score range 0-50, lower is better

    Measured: 6 months

  8. School absence

    Days absent from school past 3 months or since last visit

    Measured: 6 months

  9. Parental care load

    Sick leave number of days

    Measured: 6 months

  10. Change in laboratory assessments

    Inflammatory measures as specified in CRF, lower is better

    Measured: 6 months

  11. Adverse events

    Parent/child report

    Measured: 6 months

  12. Magnetic Resonance Imaging (MRI)

    In a subgroup who can tolerate MRI without general anaesthesia. Specially developed protocol for measuring inflammation signs

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2020
  2. Study start12 Jan 2021
  3. Primary completion15 Oct 2025
  4. Study completion15 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label single-arm trial
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04609761
Sponsor's protocol ID
IVIGPANSOpen
Status last verified
Oct 2025
First submitted
5 Oct 2020
Last updated
6 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hajjari P, Oldmark MH, Fernell E, Jakobsson K, Vinsa I, Thorsson M, Monemi M, Stenlund L, Fasth A, Furuhjelm C, Johnels JA, Gillberg C, Johnson M. Paediatric Acute-onset Neuropsychiatric Syndrome (PANS) and intravenous immunoglobulin (IVIG): comprehensive open-label trial in ten children. BMC Psychiatry. 2022 Aug 6;22(1):535. doi: 10.1186/s12888-022-04181-x.

    PubMed 35933358

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Privigen Injectable Product (Intravenous Immunoglobulin) in people with PANS Pediatric Acute-Onset Neuropsychiatric Syndrome, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) scale symptoms and impairment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04609761, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in