Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
Study NCT ID:
NCT06673368
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2024-11-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR With NRCT-202XR Compared to NRCT-202XR Alone in Subjects With Attention-Deficit/Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2024-11-01', 'studyFirstSubmitQcDate': '2024-11-01', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CGI-S', 'timeFrame': '6 weeks'}, {'measure': 'SDSE-RS', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'CBRS-P', 'timeFrame': '6 weeks', 'description': 'and academic problems in children between the ages of 6 and 18 years and are reported by parents.'}, {'measure': 'DPREMB-R', 'timeFrame': '6 weeks'}, {'measure': 'ADHD-RS-5', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.', 'detailedDescription': "A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial to evaluate the safety and efficacy of co-administration of NRCT-101SR and low dose NRCT- 202XR compared to low or high dose of NRCT-202XR and placebo NRCT-101SR over a 6-week period in approximately 60 pediatric subjects (13-17 years of age) with ADHD.\n\nSubjects' enrollment will be conducted in two stages.\n\nIn stage 1, subjects are planned to be randomized to one of the following two arms (1:1 ratio):\n\nArm 1: NRCT-101SR and low dose NRCT-202XR Arm 2: NRCT-101SR placebo and high dose NRCT-202XR\n\nIn stage 2, a third study arm will be added (Arm 3 - NRCT-101SR placebo and low dose NRCT-202XR.\n\nThe study population will include male and female subjects (sex assigned at birth) of all races/ethnicities with ADHD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Male or female, 13-17 years of age at screening.\n2. Has a prior primary diagnosis of ADHD according to the DSM-5 classification evident by a medical record and confirmed with MINI using DSM-5 probes.\n3. Is taking ADHD medication 4-7 days/week, for at least 4 weeks at Screening and at least 6 weeks at Baseline.\n4. Has side effects identified using SDSE-RS at Screening and Baseline.\n5. CGI-S ≥ X (blinded) at Screening and Baseline.\n6. Must be fluent in English and communicate effectively with others.\n7. Both subject and parent/guardian willing and able to give informed assent/consent.\n8. Parent/guardian willing to serve as informant.'}, 'identificationModule': {'nctId': 'NCT06673368', 'briefTitle': 'A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR With NRCT-202XR Compared to NRCT-202XR Alone in Subjects With Attention-Deficit/Hyperactivity Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocentria, Inc.'}, 'officialTitle': 'A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR With NRCT-202XR Compared to NRCT-202XR Alone in Subjects With Attention-Deficit/Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'NC-022A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'NRCT-101SR and low dose NRCT-202XR', 'interventionNames': ['Drug: NRCT-101SR, NRCT-202XR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'NRCT-101SR placebo and high dose NRCT-202XR', 'interventionNames': ['Drug: NRCT-101SR, NRCT-202XR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3', 'description': 'NRCT-101SR placebo and low dose NRCT-202XR', 'interventionNames': ['Drug: NRCT-101SR, NRCT-202XR']}], 'interventions': [{'name': 'NRCT-101SR, NRCT-202XR', 'type': 'DRUG', 'description': 'NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Houle', 'role': 'CONTACT', 'email': 'Lisa.Houle@accelclinical.com', 'phone': '407-644-1165'}, {'name': 'Marlene Serrano', 'role': 'CONTACT', 'email': 'Marlene.Serrano@accelclinical.com', 'phone': '407-644-1165'}, {'name': 'Andrea Marraffino', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Accel Research Site-Maitland Clinical Research Unit', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Morgan Hecker', 'role': 'CONTACT', 'email': 'M.Hecker@CenExel.com', 'phone': '(404) 537-1281'}, {'name': 'Kimball Johnson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'iResearch Atlanta', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Skyler McPherson', 'role': 'CONTACT', 'email': 's.mcpherson@cenexel.com', 'phone': '(912)744-0800'}, {'name': 'Yael Elfassy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CenExel iRS - iResearch Savannah', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joanne Monaghan', 'role': 'CONTACT', 'email': 'joanne.monaghan@bostontrials.com', 'phone': '(617) 477-4868'}, {'name': 'Shazia Naveed', 'role': 'CONTACT', 'email': 'shazia.naveed@bostontrials.com', 'phone': '(617) 477-4868'}, {'name': 'Irina Mezhebovsky, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Boston Clinical Trials LLC', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allison Buen', 'role': 'CONTACT', 'email': 'abuen.cpbm@gmail.com', 'phone': '702-838-0742', 'phoneExt': '702-838-0742'}, {'name': 'Greg Childress', 'role': 'CONTACT', 'email': 'gchildress.cpbm@gmail.com', 'phone': '702-838-0742'}, {'name': 'Ann Childress, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center For Psychiatry and Behavioral Medicine', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'centralContacts': [{'name': 'Mia Taylor, BS', 'role': 'CONTACT', 'email': 'info@neurocentria.com', 'phone': '(925) 954-4868'}, {'name': 'Guy Bar-Klein, PhD', 'role': 'CONTACT', 'email': 'info@neurocentria.com', 'phone': '(925) 954-4868'}], 'overallOfficials': [{'name': 'Guy Bar-Klein, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neurocentria, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocentria, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}