Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-30 @ 2:57 PM
Study NCT ID:
NCT00368069
Status:
COMPLETED
Last Update Posted:
2020-07-15
First Post:
2006-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'UCB Clinical Trial Call Center', 'organization': 'UCB Pharma'}, 'certainAgreement': {'otherDetails': 'UCB has \\> 60 days but \\<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).', 'description': 'Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Keppra®', 'description': 'Keppra® extended release formulation (XR)', 'otherNumAtRisk': 77, 'otherNumAffected': 23, 'seriousNumAtRisk': 77, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo', 'otherNumAtRisk': 79, 'otherNumAffected': 21, 'seriousNumAtRisk': 79, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 21, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Partial seizures with secondary generalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Simple partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Stupor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Keppra®', 'description': 'Keppra® extended release formulation (XR)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.912', 'spread': '0.053', 'groupId': 'OG000'}, {'value': '1.067', 'spread': '0.052', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.155', 'ciLowerLimit': '0.009', 'ciUpperLimit': '0.301', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis of covariance (ANCOVA) on (log-) POS freq/week over Treatment period with Treatment, (log-) Baseline POS freq/week as covariate.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent reduction over Placebo', 'ciPctValue': '95', 'paramValue': '14.4', 'ciLowerLimit': '0.9', 'ciUpperLimit': '26.0', 'groupDescription': 'Treatment difference was assessed through the percent reduction in POS freq/week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data', 'statisticalMethod': 'Transf. of ANCOVA results on log data', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Percent Reduction of Keppra over PBO is calculated based on the ANCOVA on log data as 100\\*(1-exp(LSmeans Keppra -LSMeans Placebo))'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Treatment period (12 weeks)', 'description': 'Number of POS over the treatment period standardized to 1 week period.', 'unitOfMeasure': 'seizures per week (log-transformed data)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)'}, {'type': 'SECONDARY', 'title': 'POS Seizure Frequency Per Week Over Baseline and Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Keppra®', 'description': 'Keppra® extended release formulation (XR)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'title': 'Baseline POS frequency per week', 'categories': [{'measurements': [{'value': '1.80', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '4.13'}, {'value': '2.11', 'groupId': 'OG001', 'lowerLimit': '1.33', 'upperLimit': '3.26'}]}]}, {'title': 'Treatment POS frequency per week', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '2.70'}, {'value': '1.36', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '2.85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline Period (8 weeks) - Treatment Period (12 weeks)', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population - no imputation techniques used for missing data (number of subjects with non-missing data for Baseline = ITT Population and for Treatment period = 75 patients for levetiracetam and 78 patients for PBO) Clusters of type I count are included in the count of Type I seizures'}, {'type': 'SECONDARY', 'title': 'All (Type I+II+III) Seizures Frequency Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Keppra®', 'description': 'Keppra® extended release formulation (XR)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.928', 'spread': '0.053', 'groupId': 'OG000'}, {'value': '1.086', 'spread': '0.052', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.158', 'ciLowerLimit': '0.012', 'ciUpperLimit': '0.305', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA on (log-) seizure frequency per week over Treatment period with Treatment, (log-) Baseline seizure frequency per week as covariate.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent reduction over Placebo', 'ciPctValue': '95', 'paramValue': '14.7', 'ciLowerLimit': '1.2', 'ciUpperLimit': '26.3', 'groupDescription': 'Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data', 'statisticalMethod': 'Transf. of ANCOVA results on log data', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\\*(1-exp(LSmeans Keppra -LSMeans Placebo))'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Treatment period (12 weeks)', 'description': 'Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)', 'unitOfMeasure': 'seizures per week (log-transformed data)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)'}, {'type': 'SECONDARY', 'title': '50% Response in Weekly POS Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Keppra®', 'description': 'Keppra® extended release formulation (XR)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'title': 'Response', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Non-Response', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.84', 'ciLowerLimit': '0.95', 'ciUpperLimit': '3.55', 'estimateComment': 'Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the period (baseline or treatment period.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Logistic regression analysis including Treatment as a factor.'}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment period (12 weeks)', 'description': 'A subject is considered as a 50% responder in POS if he/she has a \\>= 50% decrease from Baseline in the POS frequency/week over Treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period)'}, {'type': 'SECONDARY', 'title': 'Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Keppra®', 'description': 'Keppra® extended release formulation (XR)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'title': '< -25%', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '-25% - <25%', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '25% - <75%', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': '75% - <100%', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '100%', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Subjects with missing data during the Treatment period were considered in the category \\<-25%.'}], 'paramType': 'NUMBER', 'timeFrame': 'over the treatment period (12 weeks)', 'description': 'The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period).'}, {'type': 'PRIMARY', 'title': 'Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Keppra®', 'description': 'Keppra® extended release formulation (XR)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.914', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '1.119', 'spread': '0.048', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.205', 'ciLowerLimit': '0.070', 'ciUpperLimit': '0.341', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA on (log-) Treatment POS frequency per week with Treatment and (log-) Baseline POS frequency per week as covariate'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent reduction over Placebo', 'ciPctValue': '95', 'paramValue': '18.6', 'ciLowerLimit': '6.7', 'ciUpperLimit': '28.9', 'groupDescription': 'Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data', 'statisticalMethod': 'Transf. of ANCOVA results on log data', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\\*(1-exp(LSmeans Keppra -LSMeans Placebo))'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Treatment Period (12 weeks)', 'description': 'Number of POS over the treatment period standardized to 1 week period', 'unitOfMeasure': 'seizures per week (log-transformed data)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) Population (Analyses were performed on subjects from the PP Population with non-missing information during both baseline and treatment period)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Keppra®', 'description': 'Keppra® extended release formulation (XR)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'no blood sampling possible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The N01235 study began recruitment in August 2006 with study completion occurring in May 2007.', 'preAssignmentDetails': 'Baseline and Participant Flow data consists of the Intent-to-Treat (ITT) analysis group. The ITT group consists of all randomized subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Keppra®', 'description': 'Keppra® extended release formulation (XR)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.97', 'spread': '13.41', 'groupId': 'BG000'}, {'value': '32.38', 'spread': '12.60', 'groupId': 'BG001'}, {'value': '33.17', 'spread': '13.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31.0', 'groupId': 'BG002'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4.0', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25.0', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8.0', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38.0', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51.0', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2006-08-11', 'resultsFirstSubmitDate': '2009-04-01', 'studyFirstSubmitQcDate': '2006-08-23', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-06-05', 'studyFirstPostDateStruct': {'date': '2006-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population', 'timeFrame': 'Treatment period (12 weeks)', 'description': 'Number of POS over the treatment period standardized to 1 week period.'}, {'measure': 'Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population', 'timeFrame': 'Treatment Period (12 weeks)', 'description': 'Number of POS over the treatment period standardized to 1 week period'}], 'secondaryOutcomes': [{'measure': 'POS Seizure Frequency Per Week Over Baseline and Treatment Period', 'timeFrame': 'Baseline Period (8 weeks) - Treatment Period (12 weeks)'}, {'measure': 'All (Type I+II+III) Seizures Frequency Per Week', 'timeFrame': 'Treatment period (12 weeks)', 'description': 'Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)'}, {'measure': '50% Response in Weekly POS Frequency', 'timeFrame': 'Treatment period (12 weeks)', 'description': 'A subject is considered as a 50% responder in POS if he/she has a \\>= 50% decrease from Baseline in the POS frequency/week over Treatment period.'}, {'measure': 'Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks', 'timeFrame': 'over the treatment period (12 weeks)', 'description': 'The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Keppra® XR', 'Levetiracetam XR', 'Extended release'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '19317886', 'type': 'RESULT', 'citation': 'Peltola J, Coetzee C, Jimenez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406-14. doi: 10.1111/j.1528-1167.2008.01817.x.'}, {'pmid': '19699156', 'type': 'RESULT', 'citation': 'Richy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240-5. doi: 10.1016/j.yebeh.2009.07.013. Epub 2009 Aug 20.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of refractory epilepsy\n* Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)\n* Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method\n\nExclusion Criteria:\n\n* Seizures occurring in clusters\n* Status epilepticus within 3 months of Visit 1\n* History of non-epileptic seizures\n* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients\n* Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control'}, 'identificationModule': {'nctId': 'NCT00368069', 'briefTitle': 'A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.', 'orgStudyIdInfo': {'id': 'N01235'}, 'secondaryIdInfos': [{'id': '2006-000987-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Keppra® XR', 'description': 'Keppra® extended release formulation -XR', 'interventionNames': ['Drug: Keppra® extended release formulation - XR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Keppra® extended release formulation - XR', 'type': 'DRUG', 'otherNames': ['Levetiracetam XR'], 'description': '500mg extended release oral tablet, 2 tablets once daily', 'armGroupLabels': ['Keppra® XR']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral tablets, 2 tablets once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Curitiba', 'country': 'Brazil', 'facility': 'N01235 1007', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Kuopio', 'country': 'Finland', 'facility': 'N01235 2001', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'N01235 2003', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'country': 'Finland', 'facility': 'N01235 2002', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Chennai', 'country': 'India', 'facility': 'N01235 3008', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Chennai', 'country': 'India', 'facility': 'N01235 3010', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Gandhinagar', 'country': 'India', 'facility': 'N01235 3012', 'geoPoint': {'lat': 23.21667, 'lon': 72.68333}}, {'city': 'Hyderabad', 'country': 'India', 'facility': 'N01235 3003', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Hyderabad', 'country': 'India', 'facility': 'N01235 3004', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Lucknow', 'country': 'India', 'facility': 'N01235 3001', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'city': 'Madurai', 'country': 'India', 'facility': 'N01235 3009', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'N01235 3002', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'N01235 3007', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Visakhapatnam', 'country': 'India', 'facility': 'N01235 3011', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'city': 'Aguascalientes', 'country': 'Mexico', 'facility': 'N01235 4006', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'city': 'Distrio Federal', 'country': 'Mexico', 'facility': 'N01235 4003'}, {'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'N01235 4001', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Puebla City', 'country': 'Mexico', 'facility': 'N01235 4005', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'N01235 5001', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'N01235 5002', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'N01235 5003', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'N01235 5005', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'N01235 5006', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'N01235 5007', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'N01235 5004', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'N01235 5009', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Smolensk', 'country': 'Russia', 'facility': 'N01235 5008', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'N01235 6002', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Umhlanga', 'country': 'South Africa', 'facility': 'N01235 6003', 'geoPoint': {'lat': -29.72528, 'lon': 31.08583}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'N01235 7001', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'N01235 7004', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Lviv', 'country': 'Ukraine', 'facility': 'N01235 7005', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'city': 'Odesa', 'country': 'Ukraine', 'facility': 'N01235 7002', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'city': 'Poltava', 'country': 'Ukraine', 'facility': 'N01235 7003', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}