Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-23 @ 6:47 PM
Study NCT ID:
NCT01982812
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2013-11-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D016779', 'term': 'Malaria, Cerebral'}], 'ancestors': [{'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': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020808', 'term': 'Central Nervous System Protozoal Infections'}, {'id': 'D020807', 'term': 'Central Nervous System Parasitic Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D008288', 'term': 'Malaria'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gretchen_birbeck@urmc.rochester.edu', 'phone': '585-273-4265', 'title': 'Gretchen L. Birbeck', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month post enrollment', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Levetiracetam', 'description': 'Oral Levetiracetam administered by NG tube.\n\nOral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days', 'otherNumAtRisk': 23, 'otherNumAffected': 15, 'seriousNumAtRisk': 23, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Comparison Group', 'description': '2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion\n\n2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load', 'otherNumAtRisk': 21, 'otherNumAffected': 18, 'seriousNumAtRisk': 21, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'myoclonus', 'notes': 'myoclonic jerks while fully awake', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Anemia with persistent low retics', 'notes': 'At 30 days post d/c', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Increased AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'elevated platelet count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Decreased reticulocyte count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Abnormal ECG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Excess sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Increased ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Increased alkaline phosphotase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Increased potassium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Increased chloride', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'increased phosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'increased calcium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}], 'seriousEvents': [{'term': 'death', 'notes': 'Died with respiratory then cardiac failure as is typical of death in pediatric cerebral malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 5'}, {'term': 'elevated AST', 'notes': 'laboratory assessment at 24 hours, 7 days and 1 month post randomization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'thrombocytopenia', 'notes': 'Persistent or worsening thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Acute kidney injury', 'notes': 'Based upon creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'respiratory suppression or aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'Anemia (persistent)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'elevated ALT', 'notes': 'laboratory assessment at 24 hours, 7 days and 1 month post randomization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}, {'term': 'elevated alkaline phosphatase', 'notes': 'laboratory assessment at 24 hours, 7 days and 1 month post randomization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Grade 1-5'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Minutes With Seizure on EEG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Levetiracetam', 'description': 'Oral Levetiracetam administered by NG tube.\n\nOral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': '2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion\n\n2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load'}], 'classes': [{'categories': [{'measurements': [{'value': '165.2', 'spread': '265.9', 'groupId': 'OG000'}, {'value': '464.8', 'spread': '639.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Comparing LVT to standard AED the number of minutes spent in seizure per cEEG in the 72 hours after treatment allocation.', 'unitOfMeasure': 'minutes with seizure', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Required Additional AED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Levetiracetam', 'description': 'Oral Levetiracetam administered by NG tube.\n\nOral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': '2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion\n\n2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'Additional AEDs required (including for breakthrough seizures in LVT group) during admission for seizure control (yes/no)', 'unitOfMeasure': 'Participants requiring additional AEDs', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Time From Admission to BCS >/= 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Levetiracetam', 'description': 'Oral Levetiracetam administered by NG tube.\n\nOral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': '2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion\n\n2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load'}], 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '29.0', 'groupId': 'OG000'}, {'value': '34.6', 'spread': '27.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'The mean time in hours from admission until the subject reaches Blantyre Coma Scale of greater than or equal to 4. Participants who died are excluded from this analysis.\n\nThe Blantyre Coma Score has ranges from 0-5 based upon the a sum of the following 3 domains- Eye movement\n\n1 - Watches or follows 0 - Fails to watch or follow\n\nBest motor response 2 - Localizes painful stimulus 1 - Withdraws limb from painful stimulus 0 - No response or inappropriate response\n\nBest verbal response 2 - Cries appropriately with pain, or, if verbal, speaks\n\n1 - Moan or abnormal cry with pain 0 - No vocal response to pain', 'unitOfMeasure': 'hours of coma from admission', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparing mean time to coma resolution in hours among survivors'}, {'type': 'SECONDARY', 'title': 'Sequelae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Levetiracetam', 'description': 'Oral Levetiracetam administered by NG tube.\n\nOral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': '2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion\n\n2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load'}], 'classes': [{'title': 'Neurologically intact at discharge', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Neurologic sequelae at discharge', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Died during admission', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'Neurologic outcome in 3 categories--\n\n1. Neurologically intact at discharge\n2. Neurologic sequelae at discharge--specifically new sensory or motor deficits, ongoing seizures, or behavioral abnormalities based upon a physician examination at discharge\n3. Died during admission, never discharged', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Levetiracetam', 'description': 'Oral Levetiracetam administered by NG tube.\n\nOral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days'}, {'id': 'FG001', 'title': 'Comparison Group', 'description': '2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion\n\n2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Randomized consecutive, eligible consented children with cerebral malaria during two recruitment periods--January to June 2014 and 2015,'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Levetiracetam', 'description': 'Oral Levetiracetam administered by NG tube.\n\nOral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days'}, {'id': 'BG001', 'title': 'Standard AED', 'description': 'Standard AED regimen\n\nStandard AED: Active comparitor, Standard AED'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '41.8', 'spread': '16.7', 'groupId': 'BG001'}, {'value': '41.6', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Everyone in this Malawian study population was a black African', 'unitOfMeasure': 'participants'}, {'title': 'cerebral malaria retinopathy (present)', 'classes': [{'title': 'retinopathy positive', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'retinopathy negative', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-20', 'studyFirstSubmitDate': '2013-11-05', 'resultsFirstSubmitDate': '2016-04-28', 'studyFirstSubmitQcDate': '2013-11-05', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-20', 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minutes With Seizure on EEG', 'timeFrame': '72 hours', 'description': 'Comparing LVT to standard AED the number of minutes spent in seizure per cEEG in the 72 hours after treatment allocation.'}], 'secondaryOutcomes': [{'measure': 'Required Additional AED', 'timeFrame': '7 days', 'description': 'Additional AEDs required (including for breakthrough seizures in LVT group) during admission for seizure control (yes/no)'}, {'measure': 'Mean Time From Admission to BCS >/= 4', 'timeFrame': '7 days', 'description': 'The mean time in hours from admission until the subject reaches Blantyre Coma Scale of greater than or equal to 4. Participants who died are excluded from this analysis.\n\nThe Blantyre Coma Score has ranges from 0-5 based upon the a sum of the following 3 domains- Eye movement\n\n1 - Watches or follows 0 - Fails to watch or follow\n\nBest motor response 2 - Localizes painful stimulus 1 - Withdraws limb from painful stimulus 0 - No response or inappropriate response\n\nBest verbal response 2 - Cries appropriately with pain, or, if verbal, speaks\n\n1 - Moan or abnormal cry with pain 0 - No vocal response to pain'}, {'measure': 'Sequelae', 'timeFrame': '7 days', 'description': 'Neurologic outcome in 3 categories--\n\n1. Neurologically intact at discharge\n2. Neurologic sequelae at discharge--specifically new sensory or motor deficits, ongoing seizures, or behavioral abnormalities based upon a physician examination at discharge\n3. Died during admission, never discharged'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Seizure', 'Epilepsy', 'Cerebral Malaria']}, 'referencesModule': {'references': [{'pmid': '31672143', 'type': 'DERIVED', 'citation': 'Birbeck GL, Herman ST, Capparelli EV, Dzinjalamala FK, Abdel Baki SG, Mallewa M, Toto NM, Postels DG, Gardiner JC, Taylor TE, Seydel KB. A clinical trial of enteral Levetiracetam for acute seizures in pediatric cerebral malaria. BMC Pediatr. 2019 Nov 1;19(1):399. doi: 10.1186/s12887-019-1766-2.'}]}, 'descriptionModule': {'briefSummary': 'Pediatric cerebral malaria (CM) affects more than 3 million children each year killing \\~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. Seizures occur commonly with CM and are associated with an increased risk of death and neuropsychiatric disabilities. In this Malawi-based, safety and feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric CM.', 'detailedDescription': 'Cerebral malaria (CM) affects \\~3 million children each year, primarily in sub-Saharan Africa. Antimalarial medications can rapidly clear P. falciparum parasites, but mortality rates remain high (12-25%). Survivors do not escape unscathed--\\~30% experience neurologic sequelae including epilepsy, behavioral disorders and gross neurologic deficits. Acute seizures occur commonly in CM and are associated with higher neurologic morbidity and mortality. Seizure management in malaria endemic regions is challenging because the available antiepileptic drugs (AED) induce respiratory suppression and assisted ventilation is unavailable. More optimal seizure control may improve neurologic outcomes in pediatric CM survivors, especially if the medication used is affordable and can be delivered safely and easily in resource limited settings. The investigators conducted a dose- escalation study detailed elsewhere (NCT01660672) to determine the optimal dose for use in this safety and feasibility study of enteral levetiracetam (LVT) for seizure control in children with CM and seizures admitted to Queen Elizabeth Central Hospital in Blantyre, Malawi. Enteral LVT given via nasogastric tube (NGT) rather than an intravenous (IV) formulation will be used since LVT has excellent enteral bioavailability and IV formations are not affordable in most malaria-endemic regions. LVT 40mg/kg followed by 30mg per kg Q12 hourly. Children admitted with cerebral malaria and seizures will be randomized to LVT vs. standard of care with phenobarbital as needed comparing seizure control, safety, and neurological outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '83 Months', 'minimumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Comatose with Blantyre Comas Score ≤ 2\n* P. falciparum parasitemia via thick blood film or rapid diagnostic test\n* Active seizure in past 24 hours\n\nExclusion Criteria:\n\n* Serum creatinine \\> 2mg/dL\n* Pre-admission/concomitant treatment with antiretroviral medications for HIV (ARVs), antituberculous treatments(ATTs), or chronic use of any other enzyme-inducing medications'}, 'identificationModule': {'nctId': 'NCT01982812', 'acronym': 'LVT2', 'briefTitle': 'A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Safety and Feasibility Study of Enteral Levetiracetam vs. Phenobarbital for Seizure Control in Pediatric Cerebral Malaria', 'orgStudyIdInfo': {'id': '7R01NS074409-02', 'link': 'https://reporter.nih.gov/quickSearch/7R01NS074409-02', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01NS074409', 'link': 'https://reporter.nih.gov/quickSearch/R01NS074409', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Levetiracetam', 'description': 'Oral Levetiracetam administered by NG tube.', 'interventionNames': ['Drug: Oral Levetiracetam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard AED', 'description': 'Standard AED regimen', 'interventionNames': ['Drug: Standard AED']}], 'interventions': [{'name': 'Oral Levetiracetam', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': 'liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days', 'armGroupLabels': ['Oral Levetiracetam']}, {'name': 'Standard AED', 'type': 'DRUG', 'otherNames': ['Standard regimen of AED therapy'], 'description': 'Active comparitor, Standard AED', 'armGroupLabels': ['Standard AED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3', 'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Queen Elizabeth Central Hospital', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}], 'overallOfficials': [{'name': 'Gretchen L Birbeck, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After the finding have been published, the de-identified study data will be available to other researchers on request pending a review of their plans for using the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gretchen Birbeck', 'investigatorAffiliation': 'University of Rochester'}}}}