Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 12:37 PM
Study NCT ID:
NCT01129960
Status:
TERMINATED
Last Update Posted:
2014-07-18
First Post:
2010-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain
Sponsor:
Organization:
Raw JSON
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[{'id': 'EG000', 'title': 'Esl 1600 mg', 'description': 'Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.', 'otherNumAtRisk': 84, 'otherNumAffected': 53, 'seriousNumAtRisk': 84, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Esl 1200 mg', 'description': 'Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.', 'otherNumAtRisk': 83, 'otherNumAffected': 38, 'seriousNumAtRisk': 83, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Esl 800 mg', 'description': 'Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.', 'otherNumAtRisk': 83, 'otherNumAffected': 35, 'seriousNumAtRisk': 83, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo: Tablets will be used.', 'otherNumAtRisk': 82, 'otherNumAffected': 10, 'seriousNumAtRisk': 82, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhoida haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Senile dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Endpoint in Mean Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esl 1600 mg', 'description': 'Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.'}, {'id': 'OG001', 'title': 'Esl 1200 mg', 'description': 'Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.'}, {'id': 'OG002', 'title': 'Esl 800 mg', 'description': 'Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo: Tablets will be used.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.56', 'spread': '0.232', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.237', 'groupId': 'OG001'}, {'value': '-1.73', 'spread': '0.236', 'groupId': 'OG002'}, {'value': '-1.13', 'spread': '0.231', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3726', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': "Dunnett's test (analysis of covariance)", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8034', 'groupIds': ['OG001'], 'statisticalMethod': "Dunnett's test (analysis of covariance)", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1391', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': "Dunnett's test (analysis of covariance)", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline up to endpoint 15 weeks (3-week titration phase and 12-week treatment maintenance phase)', 'description': 'Study was prematurely halted. The efficacy analysis was restricted to the primary efficacy variable in the interim analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (31st October 2011), was the basis for the efficacy analysis; patients with less than 20 days of study medication were excluded from the analysis, except those with early discontinuation. Primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 \\["0" = no pain; "10" = the most intense pain imaginable\\]', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS = Full Analysis Set (comprised all randomized subjects with mean pain score at baseline and mean score after randomization; subjects with less than 20 days of study medication of the cut-off date were excluded from the dataset, except those that prematurely withdrew; this was the primary population used in the efficacy analysis)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esl 1600 mg', 'description': 'Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.'}, {'id': 'FG001', 'title': 'Esl 1200 mg', 'description': 'Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.'}, {'id': 'FG002', 'title': 'Esl 800 mg', 'description': 'Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo: Tablets will be used.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '82'}, {'groupId': 'FG003', 'numSubjects': '83'}]}, {'type': 'Safety', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'comment': 'One subject was randomized to placebo, but was dispensed in error with an ESL 800 mg kit at DB Visit', 'groupId': 'FG002', 'numSubjects': '83'}, {'groupId': 'FG003', 'numSubjects': '82'}]}, {'type': 'Intent-to-Treat', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '82'}, {'groupId': 'FG003', 'numSubjects': '83'}]}, {'type': 'Per-Protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '55'}]}, {'type': 'Full Analysis Set (FAS', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Discontinuation of the study by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Fifty nine (59) clinical sites in 10 countries\n\nStudy period:\n\nDate of first admission: 2010.12.06 Date of last visit: 2012.04.24'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '332', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Esl 1600 mg', 'description': 'Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.'}, {'id': 'BG001', 'title': 'Esl 1200 mg', 'description': 'Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.'}, {'id': 'BG002', 'title': 'Esl 800 mg', 'description': 'Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo: Tablets will be used.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '10.93', 'groupId': 'BG000'}, {'value': '59.0', 'spread': '11.38', 'groupId': 'BG001'}, {'value': '58.0', 'spread': '13.33', 'groupId': 'BG002'}, {'value': '59.5', 'spread': '10.25', 'groupId': 'BG003'}, {'value': '58.5', 'spread': '11.51', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '150', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '182', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '210', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '103', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 332}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-17', 'studyFirstSubmitDate': '2010-05-03', 'resultsFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2010-05-24', 'lastUpdatePostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-17', 'studyFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Endpoint in Mean Pain', 'timeFrame': 'baseline up to endpoint 15 weeks (3-week titration phase and 12-week treatment maintenance phase)', 'description': 'Study was prematurely halted. The efficacy analysis was restricted to the primary efficacy variable in the interim analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (31st October 2011), was the basis for the efficacy analysis; patients with less than 20 days of study medication were excluded from the analysis, except those with early discontinuation. Primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 \\["0" = no pain; "10" = the most intense pain imaginable\\]'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic Neuropathic Pain'], 'conditions': ['Painful Diabetic Neuropathy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment phase.', 'detailedDescription': 'Diabetic neuropathic pain (DNP) is one of the most common complications of diabetes mellitus. It currently affects about 1% of the population but its prevalence is expected to increase in coming years (European Medicines Agency 2007) in step with the increase in diabetes mellitus prevalence, which is expected to affect 220 million people by 2010\n\nThe clinical development of ESL to treat neuropathic pain is based on its chemical and pharmacodynamic relationship to sodium channel blockers, including carbamazepine, which is effective for treating some neuropathic pain conditions. Preclinical data supports the theoretical background.\n\nThis study will examine the efficacy, safety, tolerability and pharmacokinetics of Eslicarbazepine acetate for the treatment of diabetic neuropathic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female outpatients aged 18 years or older. Female subjects are of nonchildbearing potential, defined as surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or at least 2 years postmenopausal (spontaneous amenorrhea for at least 24 months before Visit 1), or if of childbearing potential, subjects agree to use a medically acceptable nonhormonal method of contraception.\n* Diagnosis of Type 1 or Type 2 diabetes mellitus.\n* Pain due to bilateral peripheral polyneuropathy caused by Type 1 or Type 2 diabetes mellitus.\n* Have stable glycemic control, as assessed by the investigator, and have glycosylated hemoglobin proportion of less or equal than 11% before randomization.\n* A mean score between 4.0 and 9.0, inclusive, on the 24 hour average pain intensity assessment and Visit 3 (ie, 5 of 7 days, 6 of 8 days, 7 of 9 days, or 7 of 10 days).\n* Compliance with patient diary completion.\n* If not used to treat DNP, subjects are permitted to take nonsteroidal anti inflammatory drugs and selective serotonin reuptake inhibitors if they were kept on a stable dose for 1 month prior to Screening and are foreseen to remain stable throughout the study.\n* Competent and able to freely give own informed consent.\n* Female subjects of childbearing potential, who are not currently breastfeeding, must have a negative serum pregnancy test at Visit 1.\n\nExclusion Criteria:\n\n* Historical exposure to drugs known to cause neuropathy.\n* Significant skin lesions (active infection, ulcer, etc).\n* Peripheral vascular disease with a history of amputation, except amputation of toes.\n* Known intolerance to ESL or to other carboxamide derivatives (eg, carbamazepine or oxcarbazepine) or frequent or severe allergic reactions with multiple medications.\n* Subjects who previously participated in a clinical study with ESL.\n* Major psychiatric disorders.\n* Serious or unstable disease that could compromise participation cause hospitalization during the study.\n* Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator.\n* Subjects taking the following drug classes and individual drugs are excluded: benzodiazepines (except short half life sleep agents), skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletine, centrally acting analgesics (dextromethorphan, tramadol), opiates, topical lidocaine, anticonvulsants, tricyclic antidepressants, and serotonin norepinephrine reuptake inhibitors. These drugs require a minimum washout period of at least 5 times the half life and should be tapered appropriately using product label instructions as a guide.\n* Relevant clinical laboratory abnormality that, in the investigator's opinion, can compromise the subject's safety.\n* History of drug abuse or dependence (drug categories defined by DSM IV) within the past year, excluding nicotine and caffeine.\n* Subjects who, in the previous 30 days, received treatment with a drug that had not received regulatory approval for any indication at the time of study entry.\n* History of recurrent epileptic seizures except febrile seizures.\n* History of severe gastroparesis or gastric bypass surgery.\n* Neurolytic treatment for DNP.\n* Injected anesthetics or steroid use within 30 days of Visit 1.\n* Malignancy within past 2 years.\n* History of chronic hepatitis B or C within the past 3 months or human immunodeficiency virus infection."}, 'identificationModule': {'nctId': 'NCT01129960', 'briefTitle': 'Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Diabetic Neuropathic Pain', 'orgStudyIdInfo': {'id': 'BIA-2093-307'}, 'secondaryIdInfos': [{'id': '2010-019100-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eslicarbazepine acetate 800 mg once daily (QD)', 'interventionNames': ['Drug: Eslicarbazepine acetate (BIA 2-093)']}, {'type': 'EXPERIMENTAL', 'label': 'Eslicarbazepine acetate 1200 mg QD', 'interventionNames': ['Drug: Eslicarbazepine acetate (BIA 2-093)']}, {'type': 'EXPERIMENTAL', 'label': 'Eslicarbazepine acetate 1600 mg QD', 'interventionNames': ['Drug: Eslicarbazepine acetate (BIA 2-093)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Eslicarbazepine acetate (BIA 2-093)', 'type': 'DRUG', 'otherNames': ['Exalief', 'Zebinix', 'BIA 2-093', 'ESL'], 'description': 'Tablets will be used.', 'armGroupLabels': ['Eslicarbazepine acetate 1200 mg QD', 'Eslicarbazepine acetate 1600 mg QD', 'Eslicarbazepine acetate 800 mg once daily (QD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets will be used.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4045-457', 'city': 'S. Mamede Do Coronado', 'state': 'S. Mamede Do Coronado', 'country': 'Portugal', 'facility': 'BIAL - Portela & Cª, S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}