Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT06810505
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718987', 'term': 'atogepant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'Up to approximately 16 weeks', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Change From Baseline in Mean Monthly Migraine Days', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Monthly Headache Days', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.'}, {'measure': 'Change From Baseline in Mean Monthly Acute Medication Use Days', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.'}, {'measure': 'Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.'}, {'measure': 'Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score.'}, {'measure': 'Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Chronic Migraine', 'Atogepant', 'QULIPTA', 'AQUIPTA'], 'conditions': ['Chronic Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M23-712', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age.\n\nAtogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world.\n\nParticipants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks.\n\nParticipants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.\n* During the last 28 days of the screening/baseline period, and as per eDiary:\n\n * Participant must have completed the eDiary for a minimum of 20 out of 28 days.\n * Participant has \\>= 15 headache days.\n * Participant has \\>= 8 migraine days.\n\nExclusion Criteria:\n\n* Clinically significant hypertension per investigator's judgment.\n* History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease."}, 'identificationModule': {'nctId': 'NCT06810505', 'briefTitle': 'A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age', 'orgStudyIdInfo': {'id': 'M23-712'}, 'secondaryIdInfos': [{'id': '2024-513836-28'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atogepant', 'description': 'Participants will receive atogepant once daily for 12 weeks.', 'interventionNames': ['Drug: Atogepant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for Atogepant', 'description': 'Participants will receive placebo for atogepant once daily for 12 weeks.', 'interventionNames': ['Drug: Placebo for Atogepant']}], 'interventions': [{'name': 'Atogepant', 'type': 'DRUG', 'otherNames': ['Qulipta', 'Aquipta'], 'description': 'Oral tablet', 'armGroupLabels': ['Atogepant']}, {'name': 'Placebo for Atogepant', 'type': 'DRUG', 'description': 'Oral tablet', 'armGroupLabels': ['Placebo for Atogepant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rehabilitation & Neurological Services /ID# 270782', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Preferred Research Partner, Inc /ID# 270389', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Preferred Research Partners /ID# 270419', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Research Center /ID# 270257', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neuro Pain Medical Center /ID# 271048', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Accellacare - Long Beach /ID# 270398', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Excell Research /ID# 270258', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '95124', 'city': 'San Jose', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Lumos Clinical Research Center /ID# 270582', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94596', 'city': 'Walnut Creek', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sunwise Clinical Research /ID# 270431', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '32561', 'city': 'Gulf Breeze', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northwest Florida Clinical Research Group, LLC /ID# 270833', 'geoPoint': {'lat': 30.35714, 'lon': -87.16386}}, {'zip': '33813', 'city': 'Lakeland', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Auzmer Research /ID# 271158', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'My Preferred Research /ID# 270312', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Encore Medical Research - Weston /ID# 271139', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '47710', 'city': 'Evansville', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Deaconess Midtown Hospital /ID# 270572', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Michigan Headache & Neurological Institute /ID# 270942', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '39157', 'city': 'Ridgeland', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Proven Endpoints LLC /ID# 270269', 'geoPoint': {'lat': 32.42848, 'lon': -90.13231}}, {'zip': '68046', 'city': 'Papillion', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cct Research - Papillion Research Center /ID# 270393', 'geoPoint': {'lat': 41.15444, 'lon': -96.04224}}, {'zip': '03060', 'city': 'Nashua', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Healthy Perspectives - Innovate Mental Health Services /ID# 270847', 'geoPoint': {'lat': 42.76537, 'lon': -71.46757}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dent Neurologic Institute - Amherst /ID# 270260', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '27405', 'city': 'Greensboro', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Headache Wellness Center /ID# 270568', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '15683', 'city': 'Scottdale', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Frontier Clinical Research - Scottdale /ID# 270854', 'geoPoint': {'lat': 40.10035, 'lon': -79.58698}}, {'zip': '15478', 'city': 'Smithfield', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Frontier Clinical Research - Smithfield /ID# 270849', 'geoPoint': {'lat': 39.80313, 'lon': -79.80783}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Access Clinical Trials Inc /ID# 270280', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78723-3079', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77058', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Earle Research /ID# 270424', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75165', 'city': 'Waxahachie', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinpoint Trials /ID# 270261', 'geoPoint': {'lat': 32.38653, 'lon': -96.84833}}, {'zip': '84010', 'city': 'Bountiful', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Pantheon Clinical Research /ID# 270259', 'geoPoint': {'lat': 40.88939, 'lon': -111.88077}}, {'zip': '84015', 'city': 'Clinton', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Alpine Research Organization - Clinton /ID# 276527', 'geoPoint': {'lat': 41.13967, 'lon': -112.0505}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Highland Clinical Research /ID# 270281', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '26537', 'city': 'Kingwood', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Frontier Clinical Research - Kingwood /ID# 271053', 'geoPoint': {'lat': 39.47176, 'lon': -79.68339}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': "London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'McGill University Health Centre - Glen Site. /ID# 270662', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '2730', 'city': 'Herlev', 'state': 'Capital Region', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Herlev Hospital /ID# 270482', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '7400', 'city': 'Herning', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Regionshospitalet Godstrup /ID# 270481', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'zip': '1085', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem /ID# 271219', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '20133', 'city': 'Milan', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '658-0064', 'city': 'Kobe', 'state': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Konan Medical Center /ID# 270486', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '780-8011', 'city': 'Kochi', 'state': 'Kochi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Umenotsuji Clinic /ID# 270484', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '556-0015', 'city': 'Osaka', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '＋81-6-6643-2660'}], 'facility': 'Tominaga Clinic - Osaka /ID# 270483', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '151-0051', 'city': 'Shibuya-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Tokyo Headache Clinic /ID# 271610'}, {'zip': '160-0023', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Tokyo Medical University Hospital /ID# 270487'}, {'zip': '994-0083', 'city': 'Tendo-shi', 'state': 'Yamagata', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Tendo Brain Clinic /ID# 271410'}, {'zip': '400-0124', 'city': 'Kai', 'state': 'Yamanashi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Nagaseki Headache Clinic /ID# 271699', 'geoPoint': {'lat': 35.68463, 'lon': 138.50979}}, {'zip': '890-0052', 'city': 'Kagoshima', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Tanaka Neurosurgery & Headache Clinic /ID# 271346', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Canisius-Wilhelmina Ziekenhuis /ID# 270374', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '2545 AA', 'city': 'The Hague', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'HagaZiekenhuis /ID# 270379', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '60-848', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Clinical Research Center Medic-R /ID# 270235', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '85-752', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Athleticomed Sp. z o.o /ID# 270243', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '30-539', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Specjalistyczne Gabinety Sp. z o.o /ID# 270238', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '52-210', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'MIGRE Polskie Centrum Leczenia Migreny /ID# 270239', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '00-414', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'OHA-MED sp. z o.o /ID# 270242', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '00918-3501', 'city': 'San Juan', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'facility': 'CMRC Headlands LLC /ID# 271300', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': 'ME7 5NY', 'city': 'Gillingham', 'state': 'Kent', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Medway Maritime Hospital /ID# 271885', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}, {'zip': 'AB25 2ZG', 'city': 'Aberdeen', 'state': 'Scotland', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': "Royal Aberdeen Children's Hospital /ID# 271664", 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'SK2 7JE', 'city': 'Stockport', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883', 'geoPoint': {'lat': 53.40979, 'lon': -2.15761}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.', 'accessCriteria': 'To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}