Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00152451
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
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 Week 1 up to Week 17', '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': 31, 'otherNumAffected': 27, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Energy increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Multiple allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anticonvulsant toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tongue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tooth injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Positive Rombergism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Red blood cell morphology abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urine analysis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coordination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Emotional disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Poor venous access', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '-30.88', 'groupId': 'OG000', 'lowerLimit': '-50.00', 'upperLimit': '-15.38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat (ITT) set included 31 subjects, who took at least one dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-40.06', 'groupId': 'OG000', 'lowerLimit': '-68.75', 'upperLimit': '1.73'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-37.50', 'groupId': 'OG000', 'lowerLimit': '-51.79', 'upperLimit': '-0.75'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-27.68', 'groupId': 'OG000', 'lowerLimit': '-53.12', 'upperLimit': '-14.29'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-39.88', 'groupId': 'OG000', 'lowerLimit': '-70.83', 'upperLimit': '-24.37'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-39.33', 'groupId': 'OG000', 'lowerLimit': '-56.76', 'upperLimit': '-1.69'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-41.67', 'groupId': 'OG000', 'lowerLimit': '-61.19', 'upperLimit': '25.00'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'groupId': 'OG000', 'lowerLimit': '-83.07', 'upperLimit': '58.65'}]}]}], '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': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', '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': '-36.36', 'groupId': 'OG000', 'lowerLimit': '-64.29', 'upperLimit': '21.81'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the down-titration 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 duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week in the down-titration period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-40.06', 'groupId': 'OG000', 'lowerLimit': '-68.75', 'upperLimit': '3.29'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-37.50', 'groupId': 'OG000', 'lowerLimit': '-51.79', 'upperLimit': '-0.75'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-27.68', 'groupId': 'OG000', 'lowerLimit': '-53.12', 'upperLimit': '-14.29'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-39.88', 'groupId': 'OG000', 'lowerLimit': '-70.83', 'upperLimit': '-24.37'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-39.33', 'groupId': 'OG000', 'lowerLimit': '-56.76', 'upperLimit': '-1.69'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-41.67', 'groupId': 'OG000', 'lowerLimit': '-61.19', 'upperLimit': '25.00'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'groupId': 'OG000', 'lowerLimit': '-83.07', 'upperLimit': '58.65'}]}]}], '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': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (Type I+II+III) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '-30.88', 'groupId': 'OG000', 'lowerLimit': '-50.00', 'upperLimit': '-15.38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', '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': '-36.36', 'groupId': 'OG000', 'lowerLimit': '-64.29', 'upperLimit': '21.81'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the down-titration 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 duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (Type I+II+III) seizure frequency per week in the down-titration period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '10.50'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.73', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '13.00'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.55', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '13.50'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '8.62'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '13.00'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '13.22'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '14.00'}]}]}], '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': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '2.74', 'groupId': 'OG000', 'lowerLimit': '1.71', 'upperLimit': '11.76'}]}]}], '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).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '2.25', 'groupId': 'OG000', 'lowerLimit': '1.63', 'upperLimit': '9.82'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12)', 'description': 'Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', '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': '3.50', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '13.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Down-Titration Period (Week 13 to Week 15)', 'description': 'Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week in the down-titration period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '10.50'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.73', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '13.00'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.55', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '13.50'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '8.62'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '13.00'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '13.22'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '14.00'}]}]}], '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': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (type I+II+III) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '2.74', 'groupId': 'OG000', 'lowerLimit': '1.71', 'upperLimit': '11.76'}]}]}], '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).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '2.25', 'groupId': 'OG000', 'lowerLimit': '1.63', 'upperLimit': '9.82'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12)', 'description': 'Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', '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': '3.50', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '13.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Down-Titration Period (Week 13 to Week 15)', 'description': 'Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for Type I+II+III seizure frequency per week in the down-titration period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '25.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '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': 'The ITT set included 31 subjects, who took at least one dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '3.2', 'groupId': 'OG000'}]}]}, {'title': '-25% to < 25%', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}]}]}, {'title': '25% to < 75%', 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}]}]}, {'title': '75% to <100%', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}]}]}, {'title': '100%', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, compared to Baseline Period (Week 1 to Week 4)', 'description': 'Categories of percentage change in seizures from Baseline were as following: \\< -25%; -25% to \\<25%; 25% to \\<75%; 75% to \\<100%; 100%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', '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': '13.80', 'groupId': 'OG000', 'lowerLimit': '4.71', 'upperLimit': '28.57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '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.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for seizure-free days per week over the up-titration period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', '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': '-0.96', 'groupId': 'OG000', 'lowerLimit': '-3.00', 'upperLimit': '1.41'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week in the down-titration period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '-1.14', 'groupId': 'OG000', 'lowerLimit': '-4.63', 'upperLimit': '-0.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week in the down-titration period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) Overall in the Down-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', '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': '-0.96', 'groupId': 'OG000', 'lowerLimit': '-3.00', 'upperLimit': '1.41'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 13 to Week 15, compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (Type I+II+III) seizure frequency per week in the down-titration period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II +III) Overall in the Up-titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '-1.14', 'groupId': 'OG000', 'lowerLimit': '-4.63', 'upperLimit': '-0.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (Type I+II+III) seizure frequency per week in the down-titration period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-3.00', 'upperLimit': '0.43'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.39', 'groupId': 'OG000', 'lowerLimit': '-4.50', 'upperLimit': '-0.25'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-5.00', 'upperLimit': '-0.45'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.94', 'groupId': 'OG000', 'lowerLimit': '-4.20', 'upperLimit': '-0.57'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.60', 'groupId': 'OG000', 'lowerLimit': '-4.75', 'upperLimit': '-0.24'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-3.23', 'upperLimit': '1.00'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'groupId': 'OG000', 'lowerLimit': '-3.52', 'upperLimit': '1.62'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '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 for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Overall 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).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', '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': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-3.00', 'upperLimit': '0.43'}]}]}, {'title': 'Visit 5 (Week 7 and 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.39', 'groupId': 'OG000', 'lowerLimit': '-4.50', 'upperLimit': '-0.25'}]}]}, {'title': 'Visit 6 (Week 9 and 10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-5.00', 'upperLimit': '-0.45'}]}]}, {'title': 'Visit 7 (Week 11 and 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.94', 'groupId': 'OG000', 'lowerLimit': '-4.20', 'upperLimit': '-0.57'}]}]}, {'title': 'Visit 8 (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.60', 'groupId': 'OG000', 'lowerLimit': '-4.75', 'upperLimit': '-0.24'}]}]}, {'title': 'Visit 9 (Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'groupId': 'OG000', 'lowerLimit': '-3.23', 'upperLimit': '1'}]}]}, {'title': 'Visit 10 (Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'groupId': 'OG000', 'lowerLimit': '-3.52', 'upperLimit': '1.62'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '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 for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The Overall 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).', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (Type I+II+III) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.'}]}, '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': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'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 May 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': '31', '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': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.41', 'spread': '10.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refer to the Intention-To-Treat (ITT) Set which consisted of all subjects who took at least one dose of trial medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2006-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2005-09-07', 'resultsFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-26', 'studyFirstPostDateStruct': {'date': '2005-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During 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': 'Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)', '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': 'Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period', 'timeFrame': 'During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the down-titration 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 duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).'}, {'measure': 'Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)', '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': 'Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in 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': 'Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).'}, {'measure': 'Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period', 'timeFrame': 'During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the down-titration 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 duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).'}, {'measure': 'Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment 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 for Partial Onset Seizure (Type I) Overall in the Treatment 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).'}, {'measure': 'Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12)', 'description': 'Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).'}, {'measure': 'Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period', 'timeFrame': 'During the Down-Titration Period (Week 13 to Week 15)', 'description': 'Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).'}, {'measure': 'Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment 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': 'Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment 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).'}, {'measure': 'Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period', 'timeFrame': 'During the Up-Titration Period (Week 5 to Week 12)', 'description': 'Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).'}, {'measure': 'Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period', 'timeFrame': 'During the Down-Titration Period (Week 13 to Week 15)', 'description': 'Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).'}, {'measure': 'Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period', 'timeFrame': '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': 'Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period', 'timeFrame': 'Week 12, compared to Baseline Period (Week 1 to Week 4)', 'description': 'Categories of percentage change in seizures from Baseline were as following: \\< -25%; -25% to \\<25%; 25% to \\<75%; 75% to \\<100%; 100%.'}, {'measure': 'Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period', 'timeFrame': '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.'}, {'measure': 'Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period', 'timeFrame': 'During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).'}, {'measure': 'Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period', 'timeFrame': 'Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).'}, {'measure': 'Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) Overall in the Down-titration Period', 'timeFrame': 'Week 13 to Week 15, compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).'}, {'measure': 'Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II +III) Overall in the Up-titration Period', 'timeFrame': 'Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)', 'description': 'Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).'}, {'measure': 'Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)', 'timeFrame': '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 for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Overall 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).'}, {'measure': 'Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)', 'timeFrame': '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 for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The Overall 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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Partial onset seizures', 'Seletracetam'], 'conditions': ['Epilepsy, Partial']}, 'descriptionModule': {'briefSummary': 'This trial will evaluate the efficacy and safety of ucb 44212 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 Antiepileptic Drug (AEDs)\n* Female subjects without childbearing potential; Female subjects 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 6 months of Visit 1\n* 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* Subjects currently taking levetiracetam (LEV)\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': 'NCT00152451', 'briefTitle': 'Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Open-label, Exploratory, Multicenter, Dose-escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs', 'orgStudyIdInfo': {'id': 'N01191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seletracetam', 'description': 'Escalating doses twice daily were to be administered.', 'interventionNames': ['Drug: Seletracetam (ucb 44212)']}], 'interventions': [{'name': 'Seletracetam (ucb 44212)', 'type': 'DRUG', 'description': '* Pharmaceutical form: oral capsules\n* Concentration: 10 and 50 mg\n* Route of administration: oral administration', 'armGroupLabels': ['Seletracetam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'N01191 108', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'N01191 105', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'N01191 102', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'N01191 107', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'N01191 104', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'N01191 101', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'N01191 103', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UCB (+1 844 599 2273)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB S.A. - Pharma Sector', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}