Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT01760993
Status:
TERMINATED
Last Update Posted:
2021-06-22
First Post:
2013-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069478', 'term': 'Lisdexamfetamine Dimesylate'}], 'ancestors': [{'id': 'D003913', 'term': 'Dextroamphetamine'}, {'id': 'D000661', 'term': 'Amphetamine'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}}, 'adverseEventsModule': {'description': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized', 'eventGroups': [{'id': 'EG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Basline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'PRIMARY', 'title': 'Columbia-Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Up to 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and week 52', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Up to 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'timeFrame': 'Baseline and 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SPD489', 'description': 'SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}]}], 'populationDescription': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2013-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-29', 'studyFirstSubmitDate': '2013-01-02', 'resultsFirstSubmitDate': '2014-05-01', 'studyFirstSubmitQcDate': '2013-01-02', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-01', 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks', 'timeFrame': 'Basline and 52 weeks'}, {'measure': 'Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks', 'timeFrame': 'Baseline and 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale', 'timeFrame': 'Baseline and week 52'}, {'measure': 'Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks', 'timeFrame': 'Baseline and 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Not Required'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.', 'detailedDescription': 'Not required'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 to 65 years of age\n* Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends \\>4 hours/week with the subject)\n* Fixed home/place of residence and can be reached by telephone\n* On a stable dose of antipsychotic medications\n* Able to swallow capsules\n\nExclusion Criteria:\n\n* -Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products\n* Treated with clozapine in past 30 days\n* Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence\n* History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions\n* Uncontrolled hypertension\n* History of thyroid disorder that has not been stabilized on thyroid medication\n* Glaucoma\n* Pregnant or nursing\n* Subject has received an investigational product or participated in a clinical study within 30 days"}, 'identificationModule': {'nctId': 'NCT01760993', 'briefTitle': 'Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3, Long-term, Open-label, Multicenter, 52-week, Flexible-dose Safety Study of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia', 'orgStudyIdInfo': {'id': 'SPD489-336'}, 'secondaryIdInfos': [{'id': '2012-003920-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPD489', 'interventionNames': ['Drug: SPD489']}], 'interventions': [{'name': 'SPD489', 'type': 'DRUG', 'otherNames': ['lisdexamfetamine dimesylate, LDX, Vyvanse'], 'description': 'Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks', 'armGroupLabels': ['SPD489']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'SP Research PLLC/Oklahoma Clinical Research Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CRI Lifetree', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}