Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT00160667
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}], 'ancestors': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C482793', 'term': 'brivaracetam'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'UCBCares@ucb.com', 'phone': '+1844599', 'title': 'UCB', 'phoneExt': '2273', 'organization': 'Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)', 'description': 'Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 8, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 19, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 18, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.16', 'spread': '30.20', 'groupId': 'OG000'}, {'value': '-26.11', 'spread': '33.73', 'groupId': 'OG001'}, {'value': '-27.36', 'spread': '34.58', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.965', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-12.82', 'ciUpperLimit': '13.41', 'estimateComment': 'Estimated value is the difference of Least Square Means.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '=0.825', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '-11.69', 'ciUpperLimit': '14.65', 'estimateComment': 'Estimated value is the difference of Least Square Means.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, last week of the 4-week Treatment Period', 'description': 'Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain.\n\nA negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with valid data for average pain intensity score at Baseline and the last week of the 4-week Treatment Period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '37.3', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, last week of the 4-week Treatment Period', 'description': 'A responder is defined as a subject with a \\>= 30 % reduction in average pain intensity score at the Evaluation Week (last week of the Treatment Period) compared to the Baseline Period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with valid data for average pain intensity score at Baseline and the last week of the 4-week Treatment Period are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.3', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '27.0', 'groupId': 'OG001'}, {'value': '-8.5', 'spread': '20.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-20.8', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '25.6', 'groupId': 'OG001'}, {'value': '-18.7', 'spread': '22.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-24.3', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '-20.2', 'spread': '36.6', 'groupId': 'OG001'}, {'value': '-25.5', 'spread': '29.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-27.5', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '-25.8', 'spread': '37.2', 'groupId': 'OG001'}, {'value': '-29.1', 'spread': '33.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, each Evaluation visit (up to Week 4)', 'description': 'Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain.\n\nA negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat set included 50 subjects treated with Placebo, 51 subjects treated with brivaracetam (BRV) 200 mg/day, 51 subjects treated with BRV 400 mg/day. Only subjects with valid data for pain intensity score at the respective visit (week) are included in the analysis. Number of participants analyzed is given separately per visit (week).'}, {'type': 'SECONDARY', 'title': 'Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.00', 'spread': '37.41', 'groupId': 'OG000'}, {'value': '-23.33', 'spread': '51.34', 'groupId': 'OG001'}, {'value': '-30.17', 'spread': '59.27', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, last assessment during the 4-week Treatment Period', 'description': "Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'.\n\nA negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline.", 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with valid data for Sleep Interference Score are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.06', 'spread': '23.83', 'groupId': 'OG000'}, {'value': '-6.96', 'spread': '28.63', 'groupId': 'OG001'}, {'value': '-18.01', 'spread': '45.27', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-33.28', 'spread': '35.27', 'groupId': 'OG000'}, {'value': '-5.69', 'spread': '46.43', 'groupId': 'OG001'}, {'value': '-27.38', 'spread': '49.76', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-34.75', 'spread': '38.22', 'groupId': 'OG000'}, {'value': '-12.86', 'spread': '55.79', 'groupId': 'OG001'}, {'value': '-35.46', 'spread': '55.88', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-42.92', 'spread': '36.37', 'groupId': 'OG000'}, {'value': '-22.05', 'spread': '54.92', 'groupId': 'OG001'}, {'value': '-37.60', 'spread': '55.77', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, each Evaluation visit (up to Week 4)', 'description': "Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'.\n\nA negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline.", 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included 50 subjects treated with Placebo, 51 subjects treated with brivaracetam (BRV) 200 mg/day, 51 subjects treated with BRV 400 mg/day. Only subjects with valid data for Sleep Interference Score at the respective visit (week) are included in the analysis. Number of participants analyzed is given separately per visit (week).'}, {'type': 'SECONDARY', 'title': 'Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Total Pain Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.44', 'spread': '5.92', 'groupId': 'OG000'}, {'value': '-4.65', 'spread': '6.80', 'groupId': 'OG001'}, {'value': '-4.62', 'spread': '6.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'The SF-MPQ has three components: the first one consists of 15 subscales (descriptors: 11 sensory, 4 affective) which are rated on an intensity scale with 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total subscales (descriptors). The SF-MPQ also includes a Present Pain Intensity (PPI) index and a visual analogue scale (VAS). Each of the 15 subscales is rated from 0=none to 3=severe pain. The Total Pain Score of the SF-MPQ is the sum of all 15 ratings and can hence vary from 0 (15\\*0=0: no pain) to 60 (15\\*4=60: severe pain). The mean change in total score is reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Sensory Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.42', 'spread': '5.10', 'groupId': 'OG000'}, {'value': '-3.79', 'spread': '5.50', 'groupId': 'OG001'}, {'value': '-4.17', 'spread': '5.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.\n\nThe sensory score ranges from 0 to 33. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean.\n\nA negative value in absolute change indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects having values at randomization and at Evaluation (V5) / Early Discontinuation are included.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Affective Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.04', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '-0.75', 'spread': '3.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.\n\nThe affective score ranges from 0 to 12. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean.\n\nA negative value in absolute change indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Present pain intensity (PPI) was rated by the subject. The score ranges from 0 (no pain) to 5 (excruciating). A negative value in absolute change indicates an improvement in PPI.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.1', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '-15.5', 'spread': '25.2', 'groupId': 'OG001'}, {'value': '-17.9', 'spread': '31.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Pain burden was rated by the subject using the visual analog scale (VAS) ranging from 0 (no pain) to 100 (worst possible pain). A negative value in absolute change indicates an improvement in pain burden.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'title': 'Marked improvement', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '9.8', 'groupId': 'OG001'}, {'value': '23.4', 'groupId': 'OG002'}]}]}, {'title': 'Moderate improvement', 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}, {'value': '27.5', 'groupId': 'OG001'}, {'value': '27.7', 'groupId': 'OG002'}]}]}, {'title': 'Slight improvement', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}, {'value': '10.6', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000'}, {'value': '31.4', 'groupId': 'OG001'}, {'value': '29.8', 'groupId': 'OG002'}]}]}, {'title': 'Slight worsening', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}, {'value': '6.4', 'groupId': 'OG002'}]}]}, {'title': 'Moderate worsening', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Marked worsening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Patient´s global assessment of change in pain was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'title': 'Marked improvement', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '9.8', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}]}]}, {'title': 'Moderate improvement', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '23.5', 'groupId': 'OG002'}]}]}, {'title': 'Slight improvement', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '27.5', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000'}, {'value': '39.2', 'groupId': 'OG001'}, {'value': '27.5', 'groupId': 'OG002'}]}]}, {'title': 'Slight worsening', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13.7', 'groupId': 'OG002'}]}]}, {'title': 'Moderate worsening', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Marked worsening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Investigator´s global assessment of change was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.4', 'spread': '34.8', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '39.3', 'groupId': 'OG001'}, {'value': '-18.2', 'spread': '70.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Brush-evoked allodynia intensity was assessed by the subject on an 11-point numerical rating scale, ranging from 0= no pain to 10= unbearable Pain.\n\nA negative value in percent change indicates an improvement in brush-evoked allodynia intensity.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'OG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'OG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.39', 'spread': '17.18', 'groupId': 'OG000'}, {'value': '-25.18', 'spread': '32.10', 'groupId': 'OG001'}, {'value': '6.88', 'spread': '92.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Allodynia is pain due to a normally non-painful stimulus. The brush-evoked allodynia areas were assessed by the Investigator (location and contour of the allodynic regions drawn on a standard dermatomal map). Areas (mm²) of the allodynic regions drawn by the Investigator were afterwards computed by means of appropriate tools and calibrated templates. The larger the area in square centimeters the more allodynia. A negative value in percent change in the brush-evoked allodynia area indicates improvement.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'FG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'FG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study started to enroll patients in October 2004 and concluded in January 2006.', 'preAssignmentDetails': 'Participant Flow refers to the Randomized Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.'}, {'id': 'BG001', 'title': 'Brivaracetam 200 mg/Day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).'}, {'id': 'BG002', 'title': 'Brivaracetam 400 mg/Day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).'}, {'id': 'BG003', 'title': 'Total Title'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.06', 'spread': '10.80', 'groupId': 'BG000'}, {'value': '65.33', 'spread': '10.95', 'groupId': 'BG001'}, {'value': '65.58', 'spread': '10.21', 'groupId': 'BG002'}, {'value': '65.65', 'spread': '10.59', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refers to the Intention-to-treat (ITT) Set.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2006-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2005-09-08', 'resultsFirstSubmitDate': '2017-10-26', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-21', 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period', 'timeFrame': 'Baseline, last week of the 4-week Treatment Period', 'description': 'Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain.\n\nA negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline.'}], 'secondaryOutcomes': [{'measure': 'Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period', 'timeFrame': 'Baseline, last week of the 4-week Treatment Period', 'description': 'A responder is defined as a subject with a \\>= 30 % reduction in average pain intensity score at the Evaluation Week (last week of the Treatment Period) compared to the Baseline Period.'}, {'measure': 'Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score', 'timeFrame': 'Baseline, each Evaluation visit (up to Week 4)', 'description': 'Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain.\n\nA negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline.'}, {'measure': 'Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score', 'timeFrame': 'Baseline, last assessment during the 4-week Treatment Period', 'description': "Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'.\n\nA negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline."}, {'measure': 'Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score', 'timeFrame': 'Baseline, each Evaluation visit (up to Week 4)', 'description': "Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'.\n\nA negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline."}, {'measure': 'Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Total Pain Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'The SF-MPQ has three components: the first one consists of 15 subscales (descriptors: 11 sensory, 4 affective) which are rated on an intensity scale with 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total subscales (descriptors). The SF-MPQ also includes a Present Pain Intensity (PPI) index and a visual analogue scale (VAS). Each of the 15 subscales is rated from 0=none to 3=severe pain. The Total Pain Score of the SF-MPQ is the sum of all 15 ratings and can hence vary from 0 (15\\*0=0: no pain) to 60 (15\\*4=60: severe pain). The mean change in total score is reported.'}, {'measure': 'Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Sensory Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.\n\nThe sensory score ranges from 0 to 33. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean.\n\nA negative value in absolute change indicates an improvement.'}, {'measure': 'Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Affective Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.\n\nThe affective score ranges from 0 to 12. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean.\n\nA negative value in absolute change indicates an improvement.'}, {'measure': 'Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Present pain intensity (PPI) was rated by the subject. The score ranges from 0 (no pain) to 5 (excruciating). A negative value in absolute change indicates an improvement in PPI.'}, {'measure': 'Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Pain burden was rated by the subject using the visual analog scale (VAS) ranging from 0 (no pain) to 100 (worst possible pain). A negative value in absolute change indicates an improvement in pain burden.'}, {'measure': "Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit", 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Patient´s global assessment of change in pain was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening).'}, {'measure': "Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit", 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Investigator´s global assessment of change was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening).'}, {'measure': 'Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Brush-evoked allodynia intensity was assessed by the subject on an 11-point numerical rating scale, ranging from 0= no pain to 10= unbearable Pain.\n\nA negative value in percent change indicates an improvement in brush-evoked allodynia intensity.'}, {'measure': 'Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator', 'timeFrame': 'Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)', 'description': 'Allodynia is pain due to a normally non-painful stimulus. The brush-evoked allodynia areas were assessed by the Investigator (location and contour of the allodynic regions drawn on a standard dermatomal map). Areas (mm²) of the allodynic regions drawn by the Investigator were afterwards computed by means of appropriate tools and calibrated templates. The larger the area in square centimeters the more allodynia. A negative value in percent change in the brush-evoked allodynia area indicates improvement.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-herpetic Neuralgia (PHN)', 'Brivaracetam'], 'conditions': ['Neuralgia, Postherpetic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.briviact.com/briviact-PI.pdf?v=1479491757', 'label': 'Product Information'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion Criteria:\n\n* Male/female subject aged 18 years or older.\n* Pain present for at least 6 months after healing of the acute herpes zoster skin rash.\n* Pain intensity score assessed on an 11-point numerical pain rating scale with a score of at least 4 at the screening visit and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period.\n\nExclusion Criteria:\n\n* Subject getting any kind of psychological support to help cope with pain such as biofeedback or behavioral cognitive therapy.\n* Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for post-herpetic neuralgia (PHN) or who receives trans-electrical neural stimulation (TENS.\n* Tricyclic antidepressants (TCAs) or non-steroidal anti-inflammatory drug (NSAIDs) or permitted opioid analgesics ('strong' opioids are forbidden) that started less than 30 days and/or are not stabilized prior to screening and/or are not expected to be kept stable during the study.\n* Intake of more than two pain treatments at trial entry (screening visit) including Tricyclic antidepressants (TCAs), non-steroidal anti-inflammatory drugs (NSAIDs) or permitted opioid analgesics.\n* Subject being treated with Carbamazepine for any indication.\n* Known coexistent source of painful peripheral neuropathy or other systemic disease associated with a secondary painful neuropathy.\n* Subject being treated in the four weeks prior to screening visit with 'strong' opioid analgesics.\n\nExclusion Criteria:"}, 'identificationModule': {'nctId': 'NCT00160667', 'briefTitle': 'A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Exploratory, Double Blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Study, for the Assessment of Efficacy, Safety and Tolerability of Ucb 34714 50 mg Oral Capsules in b.i.d. Administration at the Doses of 200 mg/Day and 400 mg/Day, in Subjects (at Least 18 Years Old) Suffering From Post Herpetic Neuralgia (PHN)', 'orgStudyIdInfo': {'id': 'N01162'}, 'secondaryIdInfos': [{'id': '2004-000975-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo tablets administered twice a day.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Brivaracetam 200 mg/day', 'description': 'Brivaracetam 200 mg/day (100 mg administered twice a day).', 'interventionNames': ['Drug: Brivaracetam']}, {'type': 'EXPERIMENTAL', 'label': 'Brivaracetam 400 mg/day', 'description': 'Brivaracetam 400 mg/day (200 mg administered twice a day).', 'interventionNames': ['Drug: Brivaracetam']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Daily oral dose of two equal intakes.', 'armGroupLabels': ['Placebo']}, {'name': 'Brivaracetam', 'type': 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