A Phase 4 interventional study of IVIG in Pediatric Acute-Onset Neuropsychiatric Syndrome and Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections, sponsored by IMMUNOe Research Centers. Status unknown at 3 sites in United States. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by IMMUNOe Research Centers · Phase 4, Interventional, and Treatment
This study will evaluate the use of intravenous immunoglobulins (IVIG) at a dose of 1g/Kg/body weight given every three weeks for 6 infusions in pediatric subjects ages 4 - 16 years with moderate to severe PANS. The study will compare biomarkers and behavioral scales before treatment, after the last infusion, 2 months, and at a minimum 6 months post-treatment.
IVIG at an immunomodulatory dose of 1 g/Kg body weight has been known to induce suppression of systemic inflammation and has been used in the treatment of autoimmune diseases. It has been proven beneficial in inflammatory conditions affecting the nervous system.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's planned enrollment of 21 is below the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →IMMUNOe Research Centers is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IVIG dose at 1 g/Kg/body weight
Biological: IVIG
Intravenous immunoglobulin
Also known as: Octagam 5%
Change in Anxiety Disorders Interview Schedule for DSM-IV, Child, Parent Versions (ADIS)
ADIS Child and Parent Interviews are designed to diagnose children with emotional disorder, where anxiety is a prominent component. Problem behaviors and diagnoses include school refusal behavior, separation anxiety, social phobia, specific phobia, panic disorder, agoraphobia, OCD and PTSD. Assessment of ADHD allows for differentiation of inattentive type, hyperactive-type, and combined type.
Time frame: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)
Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms) (total range, 0 to 40), with separate subtotals for severity of obsessions and compulsions.
Time frame: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)
Change in Yale Global Tic Severity Scale (YGTSS)
The CY-BOCS rating scale is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder (OCD). Ratings of the characteristics of obsessive or compulsive ideation and actions on a scale of 0 - 4, with 0 as none and 4 as extreme.
Time frame: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)
Change in Clinical Global Impressions (CGI)
CGI is a 3-item observer-rated scale used to measure symptom severity, global improvement, and therapeutic response. Items 1 and 2 are rated on a 7-point scale; item 3 is rated from 0 to 4
Time frame: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)
Change in biomarkers levels
Neuro-immune biomarkers
Time frame: Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Immunoglobulins, Intravenous
Obsessive-Compulsive Disorder →
IMMUNOe Research Centers