Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT00152503
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518915', 'term': 'Seletracetam'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'UCBCares@ucb.com', 'phone': '001 844 599 2273', 'title': 'UCB', 'organization': 'Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).', 'description': 'Adverse Events refer to the Intention-To-Treat (ITT) population.', 'eventGroups': [{'id': 'EG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 44, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'classes': [{'title': 'Visit 4 (Week 5 and 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.07', 'groupId': 'OG000', 'lowerLimit': '-49.29', 'upperLimit': '-5.88'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-32.05', 'groupId': 'OG000', 'lowerLimit': '-52.60', 'upperLimit': '-8.46'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-42.22', 'groupId': 'OG000', 'lowerLimit': '-66.67', 'upperLimit': '-25.00'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.67', 'groupId': 'OG000', 'lowerLimit': '-79.00', 'upperLimit': '9.02'}]}]}, {'title': 'Up-titration (Weeks 5 to 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-34.01', 'groupId': 'OG000', 'lowerLimit': '-50.69', 'upperLimit': '-13.27'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-44.44', 'groupId': 'OG000', 'lowerLimit': '-74.60', 'upperLimit': '-10.00'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.22', 'groupId': 'OG000', 'lowerLimit': '-55.56', 'upperLimit': '12.50'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.85', 'groupId': 'OG000', 'lowerLimit': '-61.79', 'upperLimit': '35.00'}]}]}, {'title': 'Down-titration (Weeks 13 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-29.29', 'groupId': 'OG000', 'lowerLimit': '-51.05', 'upperLimit': '6.06'}]}]}, {'title': 'On Treatment (Weeks 5 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.09', 'groupId': 'OG000', 'lowerLimit': '-47.38', 'upperLimit': '-13.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.\n\nThe Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'classes': [{'title': 'Visit 4 (Week 5 and 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.07', 'groupId': 'OG000', 'lowerLimit': '-49.29', 'upperLimit': '-5.88'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-32.05', 'groupId': 'OG000', 'lowerLimit': '-52.60', 'upperLimit': '-8.46'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-42.22', 'groupId': 'OG000', 'lowerLimit': '-66.67', 'upperLimit': '-25.00'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.67', 'groupId': 'OG000', 'lowerLimit': '-79.00', 'upperLimit': '9.02'}]}]}, {'title': 'Up-titration (Weeks 5 to 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-34.01', 'groupId': 'OG000', 'lowerLimit': '-50.69', 'upperLimit': '-13.27'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-44.44', 'groupId': 'OG000', 'lowerLimit': '-74.60', 'upperLimit': '-10.00'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.22', 'groupId': 'OG000', 'lowerLimit': '-55.56', 'upperLimit': '12.50'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.85', 'groupId': 'OG000', 'lowerLimit': '-61.79', 'upperLimit': '35.00'}]}]}, {'title': 'Down-Titration (Weeks 13 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-29.29', 'groupId': 'OG000', 'lowerLimit': '-51.05', 'upperLimit': '6.06'}]}]}, {'title': 'On Treatment (Weeks 5 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.09', 'groupId': 'OG000', 'lowerLimit': '-47.38', 'upperLimit': '-13.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline.\n\nThe Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'classes': [{'title': 'Visit 4 (Week 5 and 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'groupId': 'OG000', 'lowerLimit': '-2.92', 'upperLimit': '-0.17'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-3.22', 'upperLimit': '-0.39'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.83', 'groupId': 'OG000', 'lowerLimit': '-3.13', 'upperLimit': '-0.68'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'groupId': 'OG000', 'lowerLimit': '-3.13', 'upperLimit': '0.27'}]}]}, {'title': 'Up-titration (Weeks 5 to 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.36', 'groupId': 'OG000', 'lowerLimit': '-2.77', 'upperLimit': '-0.56'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.68', 'groupId': 'OG000', 'lowerLimit': '-3.63', 'upperLimit': '-0.31'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-2.63', 'upperLimit': '0.48'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.14', 'groupId': 'OG000', 'lowerLimit': '-3.11', 'upperLimit': '1.38'}]}]}, {'title': 'Down-Titration (Weeks 13 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'groupId': 'OG000', 'lowerLimit': '-2.30', 'upperLimit': '0.25'}]}]}, {'title': 'On Treatment (Weeks 5 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'groupId': 'OG000', 'lowerLimit': '-2.62', 'upperLimit': '-0.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.\n\nThe Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'classes': [{'title': 'Visit 4 (Week 5 and 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'groupId': 'OG000', 'lowerLimit': '-2.92', 'upperLimit': '-0.17'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-3.22', 'upperLimit': '-0.39'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.83', 'groupId': 'OG000', 'lowerLimit': '-3.13', 'upperLimit': '-0.68'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'groupId': 'OG000', 'lowerLimit': '-3.13', 'upperLimit': '0.27'}]}]}, {'title': 'Up-titration (Weeks 5 to 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.36', 'groupId': 'OG000', 'lowerLimit': '-2.77', 'upperLimit': '-0.56'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.68', 'groupId': 'OG000', 'lowerLimit': '-3.63', 'upperLimit': '-0.31'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-2.63', 'upperLimit': '0.48'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.14', 'groupId': 'OG000', 'lowerLimit': '-3.11', 'upperLimit': '1.38'}]}]}, {'title': 'Down-Titration (Weeks 13 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'groupId': 'OG000', 'lowerLimit': '-2.30', 'upperLimit': '0.25'}]}]}, {'title': 'On Treatment (Weeks 5 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'groupId': 'OG000', 'lowerLimit': '-2.62', 'upperLimit': '-0.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline.\n\nThe Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'classes': [{'title': 'Baseline (Week 1 to Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.63', 'groupId': 'OG000', 'lowerLimit': '2.42', 'upperLimit': '7.50'}]}]}, {'title': 'Visit 4 (Week 5 and 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.25', 'groupId': 'OG000', 'lowerLimit': '1.57', 'upperLimit': '5.96'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '5.19'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.15', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '8.40'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.27', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '5.67'}]}]}, {'title': 'Up-titration (Weeks 5 to 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.71', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '6.40'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '5.00'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.17', 'upperLimit': '9.00'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.50', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '8.75'}]}]}, {'title': 'Down-Titration (Weeks 13 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.18', 'groupId': 'OG000', 'lowerLimit': '1.59', 'upperLimit': '7.00'}]}]}, {'title': 'On Treatment (Weeks 5 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.02', 'groupId': 'OG000', 'lowerLimit': '1.67', 'upperLimit': '6.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15)', 'description': 'Calculated as 7-day partial onset seizure (type I) frequency; The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.', 'unitOfMeasure': 'seizure frequency per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'classes': [{'title': 'Baseline (Week 1 to Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.63', 'groupId': 'OG000', 'lowerLimit': '2.42', 'upperLimit': '7.50'}]}]}, {'title': 'Visit 4 (Week 5 and 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.25', 'groupId': 'OG000', 'lowerLimit': '1.57', 'upperLimit': '5.96'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '5.19'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.15', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '8.40'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.27', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '5.67'}]}]}, {'title': 'Up-titration (Weeks 5 to 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.71', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '6.40'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '5.00'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.17', 'upperLimit': '9.00'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.50', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '8.75'}]}]}, {'title': 'On Treatment (Weeks 5 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.02', 'groupId': 'OG000', 'lowerLimit': '1.67', 'upperLimit': '6.20'}]}]}, {'title': 'Down-Titration (Weeks 13 to 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.18', 'groupId': 'OG000', 'lowerLimit': '1.59', 'upperLimit': '7.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15)', 'description': 'Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.', 'unitOfMeasure': 'seizure frequency per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)', 'description': 'A responder was defined as a subject with a \\>= 50% reduction in seizure frequency per week from the Baseline Period (Week 1 to Week 4) to the end of the Up-Titration Period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available post-baseline seizure data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'classes': [{'title': '< -25%', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}]}]}, {'title': '-25% to < 25%', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': '25% to < 75%', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': '75% to <100%', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Response to treatment in partial onset seizures (type I) over the up-titration period were analyzed by the percentage change from baseline (Week 1 to Week 4) in partial seizure frequency per week over the up-titration period, grouped in 4 categories: \\<-25%, -25% to \\<25%, 25% to \\<75%, and 75% to 100%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available post-baseline seizure data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.45', 'groupId': 'OG000', 'lowerLimit': '1.45', 'upperLimit': '28.99'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)', 'description': 'A day was considered seizure-free, if no seizure was reported during 24 hours. A positive value indicates improvement from Baseline (Week 1 to Week 4).', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available post-baseline seizure data are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study started to enroll patients in August 2005 and concluded in May 2006.', 'preAssignmentDetails': 'Participant Flow refers to the Intention-To-Treat Set. The study consisted of a 4-week Baseline Period, a 11-week Treatment Period (Up-/Down-Titration) and a 2-week Post-Treatment Period. Patients were up-titrated every two weeks until the maximum tolerated dose was reached. They were maintained at this dose until the end of the 8-week Up-Titration Period and continue that dose until the Down-Titration Visit scheduled for that dose level. Patients were to be down-titrated over a 3-week Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Seletracetam', 'description': 'Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.34', 'spread': '10.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refer to the Intention-to-Treat (ITT) population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2006-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2005-09-07', 'resultsFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-31', 'studyFirstPostDateStruct': {'date': '2005-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.\n\nThe Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline.\n\nThe Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.'}, {'measure': 'Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.\n\nThe Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.'}, {'measure': 'Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline.\n\nThe Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.'}, {'measure': 'Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15)', 'description': 'Calculated as 7-day partial onset seizure (type I) frequency; The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.'}, {'measure': 'Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period', 'timeFrame': 'During the Treatment Period (Week 5 to Week 15)', 'description': 'Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.'}, {'measure': 'Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)', 'description': 'A responder was defined as a subject with a \\>= 50% reduction in seizure frequency per week from the Baseline Period (Week 1 to Week 4) to the end of the Up-Titration Period.'}, {'measure': 'Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Response to treatment in partial onset seizures (type I) over the up-titration period were analyzed by the percentage change from baseline (Week 1 to Week 4) in partial seizure frequency per week over the up-titration period, grouped in 4 categories: \\<-25%, -25% to \\<25%, 25% to \\<75%, and 75% to 100%.'}, {'measure': 'Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)', 'description': 'A day was considered seizure-free, if no seizure was reported during 24 hours. A positive value indicates improvement from Baseline (Week 1 to Week 4).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Partial Onset Seizures', 'Seletracetam', 'Levetiracetam'], 'conditions': ['Epilepsy, Partial']}, 'descriptionModule': {'briefSummary': 'This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)\n* Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized\n* Subjects who have been treated for epilepsy for \\>= 6 months and are currently uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of levetiracetam (LEV)\n* Female subjects without childbearing potential or those who are using an acceptable contraceptive method\n\nExclusion Criteria:\n\n* Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History of non-epileptic seizures\n* Subjects on vigabatrin\n* Subjects on felbamate, unless treatment has been continuous for \\>2 years\n* Ongoing psychiatric disease other than mild controlled disorders\n* Subjects with clinically significant organ dysfunction\n* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients\n* Pregnant or lactating women\n* Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs).'}, 'identificationModule': {'nctId': 'NCT00152503', 'briefTitle': 'Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Open Label, Exploratory, Dose-escalation, Multicenter Study Examining the Safety, Tolerability and Efficacy of Ucb 44212 (Seletracetam) Used at Doses of 10, 20, 40, and 80 mg b.i.d. (Total Daily Doses of 20 - 160 mg) Administration (Oral Capsules) in Adult Subjects (18 - 65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures Who Are Currently Receiving Levetiracetam (LEV) But Still Experiencing Seizures', 'orgStudyIdInfo': {'id': 'N01192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seletracetam', 'description': 'Escalating doses twice daily were to be administered.', 'interventionNames': ['Drug: Seletracetam (UCB44212)']}], 'interventions': [{'name': 'Seletracetam (UCB44212)', 'type': 'DRUG', 'description': '* Pharmaceutical form: oral capsules\n* Concentration: 2, 10 and 50 mg\n* Route of administration: oral administration', 'armGroupLabels': ['Seletracetam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Calgary', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Montreal', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UCB (+1 844 599 2273)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}