Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT01124851
Status:
COMPLETED
Last Update Posted:
2011-07-04
First Post:
2010-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2010-04-26', 'studyFirstSubmitQcDate': '2010-05-14', 'lastUpdatePostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Laboratory Tests', 'timeFrame': 'Baseline period to end of 1-week treatment period.'}, {'measure': 'ECG', 'timeFrame': 'Baseline period to end of 1-week treatment period.'}, {'measure': 'Adverse Events', 'timeFrame': 'Baseline period till 30 days after the last dose.'}, {'measure': 'Vital Signs', 'timeFrame': 'Baseline period to end of 1-week treatment period.'}], 'secondaryOutcomes': [{'measure': 'Maintenance Wakefulness Test', 'timeFrame': 'Baseline period to end of 1-week treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep disorder'], 'conditions': ['Sleep Disorder']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness. Subjects will be randomized to either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Has current diagnosis of an excessive daytime sleepiness disorder, including narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea\n* Age 18 to 60 years Exclusion Criteria\n* Has significant suicidal ideation\n* Has a history of substance abuse\n* Has a history of a certain significant medical conditions, including uncontrolled psychiatric diseases or disorders\n* Use of certain medications'}, 'identificationModule': {'nctId': 'NCT01124851', 'briefTitle': 'Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Multiple Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ABT-652 Administered Once Daily to Subjects With an Excessive Daytime Sleepiness Disorder', 'orgStudyIdInfo': {'id': 'M11-685'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days', 'interventionNames': ['Drug: ABT-652', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days', 'interventionNames': ['Drug: ABT-652', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days', 'interventionNames': ['Drug: ABT-652', 'Drug: Placebo']}], 'interventions': [{'name': 'ABT-652', 'type': 'DRUG', 'description': 'See arm description for details', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'See arm description for details', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 43241', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 38092', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 43264', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 40402', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 38122', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Hana Florian, MD/Associate Medical Director', 'oldOrganization': 'Abbott'}}}}