Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT00888693
Status:
COMPLETED
Last Update Posted:
2017-11-21
First Post:
2009-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576396', 'term': "2-(4'-(5-methylhexahydropyrrolo(3,4-b)pyrrol-1-yl)biphenyl-4-yl)-2H-pyridazin-3-one"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,', 'timeFrame': 'Days -1 to 21'}, {'measure': 'Pharmacokinetics; optional CSF for arms 7, 8 & 9', 'timeFrame': 'Days -1 to 21'}], 'secondaryOutcomes': [{'measure': 'Extrapyramidal Symptom Rating Scale', 'timeFrame': 'Day -1, Day 14'}, {'measure': 'Columbia Suicide Severity Rating Scale', 'timeFrame': 'Screening, Day 15'}, {'measure': 'Pharmacodynamics: CANTAB & PANSS', 'timeFrame': 'Screening, Day -1, Day 14'}, {'measure': 'Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified', 'timeFrame': 'Day -1, Day 15'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '24215171', 'type': 'BACKGROUND', 'citation': 'Othman AA, Haig G, Florian H, Locke C, Gertsik L, Dutta S. The H3 antagonist ABT-288 is tolerated at significantly higher exposures in subjects with schizophrenia than in healthy volunteers. Br J Clin Pharmacol. 2014 Jun;77(6):965-74. doi: 10.1111/bcp.12281.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has signed informed consent;\n* Current DSM-IV-TR diagnosis of schizophrenia;\n* Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;\n* Meets study-specific PANSS criteria;\n* Willing and able to cooperate with cognitive testing\n* Females are not pregnant, not breast-feeding;\n* Females are post-menopausal or surgically sterile or practicing birth control;\n* Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control\n\nExclusion Criteria:\n\n* Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;\n* Diagnosis of schizoaffective disorder;\n* Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;\n* Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;\n* Current clozapine treatment; suicidal ideation or behavior;\n* BMI of 39 or greater; current homicidal or violent ideation;\n* Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;\n* Positive hepatitis or HIV test result;\n* Recent clinically significant illness/infection or surgery;\n* Recent blood product transfusion, donation or loss of 5 mL/kg of blood;\n* Visual, hearing or communication disability'}, 'identificationModule': {'nctId': 'NCT00888693', 'briefTitle': 'A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'orgStudyIdInfo': {'id': 'M10-752'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ABT-288 vs placebo capsules administered orally once daily for 14 days', 'interventionNames': ['Drug: ABT-288', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'ABT-288 vs placebo capsules administered orally once daily for 14 days', 'interventionNames': ['Drug: ABT-288', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'ABT-288 vs placebo capsules administered orally once daily for 14 days', 'interventionNames': ['Drug: ABT-288', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'ABT288 vs placebo administered orally once daily for 14 days', 'interventionNames': ['Drug: ABT-288', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'ABT-288 vs placebo administered orally once daily for 14 days', 'interventionNames': ['Drug: ABT-288', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '6', 'description': 'ABT-288 vs placebo administered orally once daily for 14 days', 'interventionNames': ['Drug: ABT-288', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '7', 'description': 'ABT-288 vs placebo administered orally once daily for 14 days', 'interventionNames': ['Drug: ABT-288', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '8', 'description': 'ABT-288 vs placebo administered orally once daily for 14 days', 'interventionNames': ['Drug: ABT-288', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '9', 'description': 'ABT-288 vs placebo administered orally once daily for 14 days', 'interventionNames': ['Drug: ABT-288', 'Drug: Placebo']}], 'interventions': [{'name': 'ABT-288', 'type': 'DRUG', 'description': 'See Arm Description for details.', 'armGroupLabels': ['1', '2', '3', '4', '5', '6', '7', '8', '9']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'See Arm Description for details.', 'armGroupLabels': ['1', '2', '3', '4', '5', '6', '7', '8', '9']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Hana Florian, MD/Associate Medical Director', 'oldOrganization': 'Abbott'}}}}