Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-30 @ 6:04 AM
Study NCT ID:
NCT01235403
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2010-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078334', 'term': 'Lacosamide'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'UCB Clinical Trial Call Center', 'organization': 'UCB'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.', 'eventGroups': [{'id': 'EG000', 'title': 'Lacosamide', 'description': 'Flexible dosing between 200mg/day and 400mg/day\n\nLacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.\n\nMaintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.\n\nTaper phase if needed: 3 to 4 weeks', 'otherNumAtRisk': 100, 'otherNumAffected': 49, 'seriousNumAtRisk': 100, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 46, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'seriousEvents': [{'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Partial seizures with secondary generalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': 'Flexible dosing between 200 mg/day and 400 mg/day\n\nLacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.\n\nMaintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.\n\nTaper phase if needed: 3 to 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the study ( up to 24 - 28 weeks)', 'description': 'Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': 'Flexible dosing between 200 mg/day and 400 mg/day\n\nLacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.\n\nMaintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.\n\nTaper phase if needed: 3 to 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the study (up to 24 - 28 weeks)', 'description': 'Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': 'Flexible dosing between 200 mg/day and 400 mg/day\n\nLacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.\n\nMaintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.\n\nTaper phase if needed: 3 to 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment Period (24-week)', 'description': 'The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100.\n\nThe overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lacosamide', 'description': 'Flexible dosing between 200 mg/day and 400 mg/day\n\nLacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.\n\nMaintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.\n\nTaper phase if needed: 3 to 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other reasons for premature termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This is a 24-week study, which enrolled 100 patients at 44 sites in France.', 'preAssignmentDetails': 'The study comprises a 12-week Titration Phase and a 12-week Maintenance Phase; both phases together are regarded as the 24-week Treatment Period.\n\nParticipant Flow and Baseline Characteristics refer to the Safety Set (SS). The SS includes all subjects that received at least one dose of study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lacosamide', 'description': 'Flexible dosing between 200mg/day and 400mg/day\n\nLacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.\n\nMaintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.\n\nTaper phase if needed: 3 to 4 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '16.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-14', 'studyFirstSubmitDate': '2010-11-03', 'resultsFirstSubmitDate': '2012-12-18', 'studyFirstSubmitQcDate': '2010-11-04', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-12-18', 'studyFirstPostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study', 'timeFrame': 'During the study ( up to 24 - 28 weeks)', 'description': 'Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.'}, {'measure': 'Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study', 'timeFrame': 'During the study (up to 24 - 28 weeks)', 'description': 'Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period', 'timeFrame': 'End of Treatment Period (24-week)', 'description': 'The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100.\n\nThe overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy treatment.', 'Anti-epileptic drugs', 'Seizures'], 'conditions': ['Partial Epilepsies']}, 'referencesModule': {'references': [{'pmid': '28597842', 'type': 'RESULT', 'citation': 'Baulac M, Coulbaut S, Doty P, McShea C, De Backer M, Bartolomei F, Vlaicu M. Adjunctive lacosamide for focal epilepsy: an open-label trial evaluating the impact of flexible titration and dosing on safety and seizure outcomes. Epileptic Disord. 2017 Jun 1;19(2):186-194. doi: 10.1684/epd.2017.0907.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.\n\nExplanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization\n* Currently taking 1 to 3 concomitant marketed antiepileptic drugs\n* 18 years and older at study entry\n\nExclusion Criteria:\n\n* Previous use of lacosamide\n* Hypersensitivity to any component of lacosamide\n* Patients with partial onset seizures not clearly identifiable\n* History of generalized epilepsy\n* History of status epilepticus within last 12 months\n* Uncountable seizures due to clustering within last 12 weeks\n* Non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures\n* History of drug or alcohol abuse\n* History of suicide attempt\n* Progressive cerebral disease\n* Concomitant treatment of felbamate\n* Prior or concomitant vigabatrin use\n* Under legal protection'}, 'identificationModule': {'nctId': 'NCT01235403', 'acronym': 'SELF', 'briefTitle': 'Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Multicenter, Open Label Study to Evaluate the Tolerability, Safety and Efficacy of Lacosamide (200mg - 400mg/Day) as add-on Therapy for Patients With Partial Onset Epilepsy Using a Flexible Dose-escalation Schedule and Individualized Maintenance Doses', 'orgStudyIdInfo': {'id': 'SP1007'}, 'secondaryIdInfos': [{'id': '2010-019268-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lacosamide', 'description': 'Flexible dosing between 200mg/day and 400mg/day', 'interventionNames': ['Drug: Lacosamide']}], 'interventions': [{'name': 'Lacosamide', 'type': 'DRUG', 'otherNames': ['Vimpat®'], 'description': 'Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.\n\nMaintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.\n\nTaper phase if needed: 3 to 4 weeks', 'armGroupLabels': ['Lacosamide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Aubenas', 'country': 'France', 'geoPoint': {'lat': 44.61975, 'lon': 4.39033}}, {'city': 'Auxerre', 'country': 'France', 'geoPoint': {'lat': 47.7996, 'lon': 3.57033}}, {'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'country': 'France', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'country': 'France', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Carpentras', 'country': 'France', 'geoPoint': {'lat': 44.05507, 'lon': 5.04813}}, {'city': 'Châteaubriand', 'country': 'France', 'geoPoint': {'lat': 43.13333, 'lon': 6.15}}, {'city': 'Colmar', 'country': 'France', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'city': 'Créteil', 'country': 'France', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Gap', 'country': 'France', 'geoPoint': {'lat': 44.55858, 'lon': 6.07868}}, {'city': 'Gonesse', 'country': 'France', 'geoPoint': {'lat': 48.98693, 'lon': 2.44892}}, {'city': 'La Rochelle', 'country': 'France', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'Laval', 'country': 'France', 'geoPoint': {'lat': 48.07247, 'lon': -0.77019}}, {'city': 'Limoges', 'country': 'France', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montluçon', 'country': 'France', 'geoPoint': {'lat': 46.34015, 'lon': 2.60254}}, {'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nîmes', 'country': 'France', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Perpignan', 'country': 'France', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'city': 'Poitiers', 'country': 'France', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Pringy', 'country': 'France', 'geoPoint': {'lat': 45.94622, 'lon': 6.12608}}, {'city': 'Rennes', 'country': 'France', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint Aubin Sur Cie', 'country': 'France'}, {'city': 'Saint Julien En Gengvois', 'country': 'France'}, {'city': 'Saint-Brieuc', 'country': 'France', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'St-Malo', 'country': 'France', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Vienne', 'country': 'France', 'geoPoint': {'lat': 45.52569, 'lon': 4.87484}}, {'city': 'Villeurbanne', 'country': 'France', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}