Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT03348618
Status:
UNKNOWN
Last Update Posted:
2019-11-19
First Post:
2017-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000631768', 'term': 'Pediatric acute-onset neuropsychiatric syndrome'}, {'id': 'C537163', 'term': 'Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Anxiety Disorders Interview Schedule for DSM-IV, Child, Parent Versions (ADIS)', 'timeFrame': 'Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)', 'description': '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.'}, {'measure': "Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)", 'timeFrame': 'Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)', 'description': '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.'}, {'measure': 'Change in Yale Global Tic Severity Scale (YGTSS)', 'timeFrame': 'Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)', 'description': '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.'}, {'measure': 'Change in Clinical Global Impressions (CGI)', 'timeFrame': 'Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)', 'description': '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'}, {'measure': 'Change in biomarkers levels', 'timeFrame': 'Measurements at baseline, one week post treatment (19 weeks), and 6 + months post-treatment (43 + weeks)', 'description': 'Neuro-immune biomarkers'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obsessive-Compulsive Disorder', 'Anxiety', 'PANS', 'PANDAS', 'Children'], 'conditions': ['Pediatric Acute-Onset Neuropsychiatric Syndrome', 'Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25325534', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9464208', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33601937', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female children, 4-16 years of age\n* Diagnosis of moderate to severe PANS based on accepted criteria\n* Must be willing to follow study procedures and comply with wash-out period\n* If using prophylactic antibiotics, must be on stable dose for 3 months\n\nExclusion Criteria:\n\n* History of rheumatic fever, including Sydenham chorea (the neurologic manifestation)\n* Previous IVIG therapy within the last 6 months\n* Allergic reactions to blood products\n* Patients who, in the investigator's opinion, might not be suitable for the trial.\n* Steroid use"}, 'identificationModule': {'nctId': 'NCT03348618', 'acronym': 'PANS', 'briefTitle': 'A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'IMMUNOe Research Centers'}, 'officialTitle': 'A Multi-site, Open-Label, Pilot Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)', 'orgStudyIdInfo': {'id': 'IIS201701-PANS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVIG', 'description': 'IVIG dose at 1 g/Kg/body weight', 'interventionNames': ['Biological: IVIG']}], 'interventions': [{'name': 'IVIG', 'type': 'BIOLOGICAL', 'otherNames': ['Octagam 5%'], 'description': 'Intravenous immunoglobulin', 'armGroupLabels': ['IVIG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'IMMUNOe Research Centers', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '68046', 'city': 'Papillion', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Midwest Pediatrics', 'geoPoint': {'lat': 41.15444, 'lon': -96.04224}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Allergy, Asthma & Immunology Relief Research Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Isaac Melamed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMMUNOe Research Centers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IMMUNOe Research Centers', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Octapharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}