Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT00202605
Status:
COMPLETED
Last Update Posted:
2021-06-24
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of SPD465 in Adults With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000661', 'term': 'Amphetamine'}], 'ancestors': [{'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2006-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-21', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PERMP (Permanent Product Measure of Performance)', 'timeFrame': '0.5 hours pre-dosing'}, {'measure': 'PERMP (Permanent Product Measure of Performance)', 'timeFrame': '2 hours post-dosing'}, {'measure': 'PERMP (Permanent Product Measure of Performance)', 'timeFrame': '4 hours post-dosing'}, {'measure': 'PERMP (Permanent Product Measure of Performance)', 'timeFrame': '8 hours post-dosing'}, {'measure': 'PERMP (Permanent Product Measure of Performance)', 'timeFrame': '12 hours post-dosing'}, {'measure': 'PERMP (Permanent Product Measure of Performance)', 'timeFrame': '14 hours post-dosing'}, {'measure': 'PERMP (Permanent Product Measure of Performance)', 'timeFrame': '16 hours post-dosing'}], 'secondaryOutcomes': [{'measure': 'Time Segment Rating System (ADHD-RS[TSRS])', 'timeFrame': '5½, 11, and 16½ hours post-dosing'}, {'measure': 'Subject self report (ADHD-SRS) of ADHD', 'timeFrame': 'approximately 5½, 11, and 16½ hours post-dosing'}, {'measure': 'Treatment emergent adverse events', 'timeFrame': 'Throughout the study period of approximately 3.25 months.'}, {'measure': 'Modified Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit'}]}, 'conditionsModule': {'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'referencesModule': {'references': [{'pmid': '29087231', 'type': 'DERIVED', 'citation': 'Wigal T, Childress A, Frick G, Yan B, Wigal S, Madhoo M. Effects of SHP465 mixed amphetamine salts in adults with ADHD in a simulated adult workplace environment. Postgrad Med. 2018 Jan;130(1):111-121. doi: 10.1080/00325481.2018.1389227. Epub 2017 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Primary diagnosis of ADHD using DSM-IV-TR criteria (at least 6 of the 9 subtype criteria met)\n* Baseline ADHD-RS-IV score =\\>24\n* IQ score of =\\> 80 (using Kaufman Brief Intelligence Test)\n\nExclusion Criteria:\n\n* BMI \\< 18.5 or \\> 30 kg/m2\n* Diagnosis of Post Traumatic Stress Disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder\n* History of seizure disorder or a lifetime history of any seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder\n* History of uncontrolled hypertension or currently hypertensive\n* Subjects who have taken atomoxetine (STRATTERA) within 30 days prior to screening\n* Current (or history within the last 12 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine)\n* Female subject is pregnant or lactating, less than 3 months post partum"}, 'identificationModule': {'nctId': 'NCT00202605', 'briefTitle': 'Safety and Efficacy of SPD465 in Adults With ADHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase II, Randomized, Double-Blind, Multi-center, Placebo-controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'SPD465-203'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Study Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UCI Child Development Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Center for Psychiatry and Behavioral Medicine, Inc.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Bayou City Research, Ltd.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}