Intravenous immunoglobulin (IVIG) treatment in children with PANS: a clinical trial in South-western Swede

Phase 1

• Conditions: Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) is a research diagnosis given to patients who have an abrupt, dramatic onset of neuropsychiatric symptoms including obsessions/compulsions and/or food restriction, and several other neuropsychiatric symptoms.; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-004758-27-SE
• Lead Sponsor: Gillberg Neuropsychiatry Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-13
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. The subject and parents/caregivers have given written consent or assent to participate
in the study.
2. Children and adolescents between the ages of 4 and 17 years at Baseline.
3. Documented and confirmed pre-existing diagnosis of post-infectious PANS/PANDAS
4. The subject has not been treated with IVIG previously or not been treated for the last 6
months
5. If the patient is on long-term antibiotic prophylaxis, this should be unchanged one month
before baseline and during the trial.
6. Infections occurring during the trial should be treated according to standard clinical
practice.
7. 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.
8. 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.
9. The medical records for all subjects should be available to document diagnosis, previous
infections and treatment.
10. 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.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. Spinal tap results are required before study start to rule out
encephalitis (which would need to be treated according to encephalitis treatment
guidelines).
2. The subject has had a known serious adverse reaction to immunoglobulin or any severe
anaphylactic reaction to blood or any blood-derived product
3. 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, postovulation methods], declaration of abstinence for the duration of a trial, and withdrawal
are not acceptable methods of contraception.)
4. 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
5. 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.
6. The subject has hemoglobin < 90 g/L at Screening
7. 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
8. 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.
9. The subject currently has a known hyperviscosity syndrome
10. 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).
11. The subject is HIV positive by NAT based on a Screening blood sample.
12. The subject has non-controlled arterial hypertension at a level of greater than or equal

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified