Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-03-05 @ 7:57 AM
Study NCT ID:
NCT01886469
Status:
COMPLETED
Last Update Posted:
2014-10-03
First Post:
2013-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of Modified Release Amphetamine (HLD100, Formulations B, C and E)) in Adolescents and Children With Attention-Deficit Hyperactivity Disorder (ADHD)
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-02', 'studyFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2013-06-25', 'lastUpdatePostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim)', 'timeFrame': '48hrs'}], 'secondaryOutcomes': [{'measure': 'Safety (AEs, ECG, laboratory parameters, physical examinations)', 'timeFrame': '48 hours'}]}, 'conditionsModule': {'conditions': ['Attention-Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to determine the rate and extent of absorption of one or more modified release formulations of amphetamine (HLD100) in both adolescents and children with ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria\n\n* Male and female adolescents (12-17 years; Stage 1) and children (6-11 years; Stage 2).\n* Diagnosis of ADHD and confirmed on Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS).\n* ADHD symptoms controlled on a stable dose of Vyvanse, Adderall XR and or Dexedrine.\n* Provision of informed consent (from parent\\[s\\] or legal representative\\[s\\]) and assent (from subject) for patients.\n\nMain Exclusion Criteria\n\n* Comorbid psychiatric diagnosis (e.g., psychosis, bipolar disorder).\n* History of seizures or current diagnosis or family history of Tourette's disorder.\n* Use of prescription drugs (except Vyvanse, Dexedrine or Adderall XR) the 14 days and over-the-counter drugs (except birth control) the 30 days before the study."}, 'identificationModule': {'nctId': 'NCT01886469', 'briefTitle': 'A Phase II, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of Modified Release Amphetamine (HLD100, Formulations B, C and E)) in Adolescents and Children With Attention-Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'OTHER', 'fullName': 'Ironshore Pharmaceuticals and Development, Inc'}, 'officialTitle': 'A Phase II, Two-Stage, Open-Label, Single-Treatment, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of up to Three Separate HLD100 Modified Release Formulations of Dextroamphetamine Sulfate in Adolescent (Stage 1) and Pediatric (Stage 2) Patients With Attention-Deficit Hyperactivity Disorder.', 'orgStudyIdInfo': {'id': 'HLD100-102'}, 'secondaryIdInfos': [{'id': 'HLD100-102 (Control # 163513)', 'type': 'OTHER', 'domain': 'Health Canada'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adolescents (12-17yrs)', 'interventionNames': ['Drug: HLD100-B', 'Drug: HLD100-C', 'Drug: HLD100-E']}, {'type': 'EXPERIMENTAL', 'label': 'Children (6-11 yrs)', 'interventionNames': ['Drug: HLD100-B', 'Drug: HLD100-C', 'Drug: HLD100-E']}], 'interventions': [{'name': 'HLD100-B', 'type': 'DRUG', 'description': 'd-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)', 'armGroupLabels': ['Adolescents (12-17yrs)', 'Children (6-11 yrs)']}, {'name': 'HLD100-C', 'type': 'DRUG', 'description': 'd-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, fast release; formulation E) - this intervention may be deemed unnecessary based on results from Intervention 1.', 'armGroupLabels': ['Adolescents (12-17yrs)', 'Children (6-11 yrs)']}, {'name': 'HLD100-E', 'type': 'DRUG', 'description': 'd-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, medium release; formulation E) - this intervention may be deemed unnecessary based on results from Interventions 1 and 2.', 'armGroupLabels': ['Adolescents (12-17yrs)', 'Children (6-11 yrs)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ironshore Pharmaceuticals and Development, Inc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}