Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-28 @ 5:33 PM
Study NCT ID:
NCT00227461
Status:
UNKNOWN
Last Update Posted:
2021-02-17
First Post:
2005-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2005-09-26', 'studyFirstSubmitQcDate': '2005-09-26', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech and language assessment', 'timeFrame': '6 months - 1year'}], 'secondaryOutcomes': [{'measure': 'Memory assessment', 'timeFrame': '6 months to 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aphasia', 'Stroke'], 'conditions': ['Aphasia', 'Stroke']}, 'descriptionModule': {'briefSummary': 'The study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia.', 'detailedDescription': 'In the study, 50 post-stroke subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke\n* Aphasia\n* Can give consent\n\nExclusion Criteria:\n\n* Renal failure\n* Pregnancy\n* Other neurological condition'}, 'identificationModule': {'nctId': 'NCT00227461', 'briefTitle': 'Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Kessler Foundation'}, 'officialTitle': 'Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.', 'orgStudyIdInfo': {'id': 'AMBarrett1'}, 'secondaryIdInfos': [{'id': 'none applicable'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Wait control', 'description': 'Levitiracetam is started after a delay, with dosage and administration as described below.', 'interventionNames': ['Drug: Levetiracetam first, then wait']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment first', 'description': 'Levitiracetam is started immediately after baseline data is collected; dosage and administration as described below.', 'interventionNames': ['Drug: Wait first, then levetiracetam']}], 'interventions': [{'name': 'Wait first, then levetiracetam', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': 'Levetiracetam 250 mg orally twice daily for 7 days. This will increase to 500 mg oral twice daily for 7 days the following week. If this dose is tolerated, it will then be increased to 750 mg orally twice daily for another 7 days and then increased to 1000 mg orally twice daily for 7 days.', 'armGroupLabels': ['Treatment first']}, {'name': 'Levetiracetam first, then wait', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': 'subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design', 'armGroupLabels': ['Wait control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kessler Foundation', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}], 'overallOfficials': [{'name': 'A.M. Barrett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kessler Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kessler Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'UCB Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Stroke Rehabilitation Research', 'investigatorFullName': 'A. M. Barrett, MD', 'investigatorAffiliation': 'Kessler Foundation'}}}}