Viewing Study NCT01229735

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 10:31 PM

Ignite Modification Date: 2025-12-28 @ 6:31 AM

Study NCT ID: NCT01229735

Status: COMPLETED

Last Update Posted: 2017-08-15

First Post: 2010-10-26

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}, {'id': 'D000077236', 'term': 'Topiramate'}], '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'}, {'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1877 822', 'title': 'UCB Clinical Trial Call Center', 'phoneExt': '9493', 'organization': 'UCB Pharma'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).', 'description': 'The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Levetiracetam', 'description': '250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks', 'otherNumAtRisk': 177, 'otherNumAffected': 86, 'seriousNumAtRisk': 177, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Topiramate', 'description': '25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks', 'otherNumAtRisk': 166, 'otherNumAffected': 91, 'seriousNumAtRisk': 166, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 32, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 40, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 47, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 24, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}], 'seriousEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Alcoholic pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Trigger finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Stupor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam (Full Analysis Set)', 'description': '250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks'}, {'id': 'OG001', 'title': 'Topiramate (Full Analysis Set)', 'description': '25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000'}, {'value': '56.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.7007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.7', 'pValueComment': 'P-value is from likelihood ratio test of treatment group regression coefficient against 0.', 'groupDescription': 'The Odds Ratio (OR) for LEV vs TPM is based on logistic regression modeling of subject retention by treatment and center pooling category. A profile likelihood confidence interval for the OR is presented.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 52', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who returned at least 1 post-baseline seizure diary.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': '250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks'}, {'id': 'OG001', 'title': 'Topiramate', 'description': '25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 52', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': '250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks'}, {'id': 'OG001', 'title': 'Topiramate', 'description': '25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'For time to Study Drug Discontinuation due to AE, Kaplan-Meier estimation of event-free subjects does not fall to or below 75%, therefore no first quartile, median or third quartile of the time to event could be estimated in either group.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'For time to Study Drug Discontinuation due to AE, Kaplan-Meier estimation of event-free subjects does not fall to or below 75%, therefore no first quartile, median or third quartile of the time to event could be estimated in either group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Week 52', 'unitOfMeasure': 'month', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam (Full Analysis Set)', 'description': '250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks'}, {'id': 'OG001', 'title': 'Topiramate (Full Analysis Set)', 'description': '25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '74.47', 'groupId': 'OG000', 'lowerLimit': '38.00', 'upperLimit': '96.28'}, {'value': '67.86', 'groupId': 'OG001', 'lowerLimit': '29.21', 'upperLimit': '87.24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Week 52', 'description': 'Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.', 'unitOfMeasure': 'percent reduction', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all subjects in the Safety Set (SS) who returned at least 1 postbaseline seizure diary.'}, {'type': 'SECONDARY', 'title': 'Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam (Full Analysis Set)', 'description': '250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks'}, {'id': 'OG001', 'title': 'Topiramate (Full Analysis Set)', 'description': '25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 52', 'unitOfMeasure': 'responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all subjects in the SS who returned at least 1 postbaseline seizure diary.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levetiracetam', 'description': '250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks'}, {'id': 'FG001', 'title': 'Topiramate', 'description': '25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '166'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'SAE, non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'AE, non-serious non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'SAE, non-fatal+AE, non-serious non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '447 subjects were screened, 343 subjects were randomized.', 'preAssignmentDetails': 'Participant Flow refers to the Randomized Set which consists of all subjects who were randomized in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Levetiracetam', 'description': '250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks'}, {'id': 'BG001', 'title': 'Topiramate', 'description': '25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks'}, {'id': 'BG002', 'title': 'Total Title'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '39.7', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '40.3', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Baseline Characteristics refers to the Safety Set which consists of all subjects who were randomized and received at least 1 dose of trial medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 343}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-06', 'studyFirstSubmitDate': '2010-10-26', 'resultsFirstSubmitDate': '2015-11-09', 'studyFirstSubmitQcDate': '2010-10-27', 'lastUpdatePostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-13', 'studyFirstPostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate', 'timeFrame': 'From Baseline to Week 52'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52', 'timeFrame': 'From Baseline to Week 52'}, {'measure': 'Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)', 'timeFrame': 'From Baseline to Week 52'}, {'measure': 'Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52', 'timeFrame': 'From Baseline to Week 52', 'description': 'Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.'}, {'measure': 'Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52', 'timeFrame': 'From Baseline to Week 52'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['levetiracetam', 'topiramate', 'epilepsy', 'partial seizures'], 'conditions': ['Epilepsy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted\n* Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE).\n* Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification\n* Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification\n* Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)\n* Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.\n* Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period.\n\nExclusion Criteria:\n\n* Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981)\n* Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification)\n* Subjects suffering from special syndromes (classification IV according to the ILAE classification)\n* History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2.\n* Presence of exclusively type IA non-motor seizures.\n* History or presence of status epilepticus within last 3 months preceding V1 or during Baseline\n* History or presence of known pseudo-seizures\n* Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the past and have a normal visual field test are allowed.)\n* Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)'}, 'identificationModule': {'nctId': 'NCT01229735', 'briefTitle': 'Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures', 'orgStudyIdInfo': {'id': 'N01353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levetiracetam', 'description': '250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks', 'interventionNames': ['Drug: Levetiracetam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topiramate', 'description': '25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks', 'interventionNames': ['Drug: Topiramate']}], 'interventions': [{'name': 'Levetiracetam', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': '250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks', 'armGroupLabels': ['Levetiracetam']}, {'name': 'Topiramate', 'type': 'DRUG', 'description': '25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks', 'armGroupLabels': ['Topiramate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': '14', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': '21', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': '8', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': '9', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': '12', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': '13', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': '10', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': '25', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': '15', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': '7', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Kyunggi-Do', 'country': 'South Korea', 'facility': '11'}, {'city': 'Kyunggi-do', 'country': 'South Korea', 'facility': '19'}, {'city': 'Kyunggi-Do', 'country': 'South Korea', 'facility': '23'}, {'city': 'Kyunggi-Do', 'country': 'South Korea', 'facility': '24'}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '16', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '17', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '18', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '1', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '2', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '3', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '4', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '5', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '6', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': '22', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Korea Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}