Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Octapharma | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG | Experimental | IVIG dose at 1 g/Kg/body weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG | Biological | Intravenous immunoglobulin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 | Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks) |
| Change in biomarkers levels |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Isaac Melamed, MD | IMMUNOe Research Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | United States | ||
| Midwest Pediatrics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Swedo SE, Leckman JF Rose NR. From research subgroup to clinical syndrome: Modifying the PANDAS criteria to describe PANS (Pediatric Acute-onset Neuropsychiatric Syndrome). Pediatr Therapeut 2012, 2:2. | ||
| 25325534 | Background | Chang K, Frankovich J, Cooperstock M, Cunningham MW, Latimer ME, Murphy TK, Pasternack M, Thienemann M, Williams K, Walter J, Swedo SE; PANS Collaborative Consortium. Clinical evaluation of youth with pediatric acute-onset neuropsychiatric syndrome (PANS): recommendations from the 2013 PANS Consensus Conference. J Child Adolesc Psychopharmacol. 2015 Feb;25(1):3-13. doi: 10.1089/cap.2014.0084. Epub 2014 Oct 17. | |
| 9464208 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Neuro-immune biomarkers
| Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks) |
| Papillion |
| Nebraska |
| 68046 |
| United States |
| Allergy, Asthma & Immunology Relief Research Institute | Charlotte | North Carolina | 28204 | United States |
| Background |
| Swedo SE, Leonard HL, Garvey M, Mittleman B, Allen AJ, Perlmutter S, Lougee L, Dow S, Zamkoff J, Dubbert BK. Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections: clinical description of the first 50 cases. Am J Psychiatry. 1998 Feb;155(2):264-71. doi: 10.1176/ajp.155.2.264. |
| 33601937 | Derived | Melamed I, Kobayashi RH, O'Connor M, Kobayashi AL, Schechterman A, Heffron M, Canterberry S, Miranda H, Rashid N. Evaluation of Intravenous Immunoglobulin in Pediatric Acute-Onset Neuropsychiatric Syndrome. J Child Adolesc Psychopharmacol. 2021 Mar;31(2):118-128. doi: 10.1089/cap.2020.0100. Epub 2021 Feb 18. |
| ID | Term |
|---|---|
| C000631768 | Pediatric acute-onset neuropsychiatric syndrome |
| C537163 | Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections |
| D009771 | Obsessive-Compulsive Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided