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Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

Primary Purpose

Chronic Migraine

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atogepant 30 mg
Atogepant 60 mg
Placebo
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least a 1-year history of CM consistent with a diagnosis according to the ICHD-3, 2018
  • Age of the participant at the time of migraine onset < 50 years

  • Confirmation of headache/migraine headache day frequency as follows:

    • History of, on average, ≥ 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND
    • >=15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
    • >=8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary
  • Participants must be using a medically acceptable and effective method of birth control during the course of the entire study

Exclusion Criteria:

  • Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine
  • Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
  • Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 and Visit 2.

Sites / Locations

  • Barrow Neuro Institute /ID# 236776
  • Baptist Health Center for Clinical Research /ID# 237361
  • California Headache and Balance Center /ID# 236246
  • Wr-Pri Llc /Id# 236008
  • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692
  • Schuster Medical Research Institute /ID# 236447
  • Alpine Clinical Research Center /ID# 234346
  • George Washington University Medical Faculty Associates /ID# 238011
  • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161
  • Accel Research Sites - Tampa Clinical Research Unit /ID# 237485
  • Premiere Research Institute - Palm Beach /ID# 238192
  • NeuroTrials Research Inc. /ID# 237364
  • Josephson-Wallack-Munshower Neurology - NE /ID# 238234
  • Collective Medical Research /ID# 236400
  • Ochsner Clinic Foundation /ID# 236543
  • Beth Israel Deaconess Medical Center /ID# 237540
  • BTC of New Bedford /ID# 236384
  • Clinical Research Institute, Inc /ID# 238299
  • Headache Neurology Research Institute /ID# 236464
  • Nevada Headache Institute /ID# 236420
  • Dartmouth-Hitchcock Medical Center /ID# 237444
  • Albuquerque Clinical Trials, Inc /ID# 236853
  • Albany Medical Center Rheumatology /ID# 236540
  • Dent Neurosciences Research Center, Inc. /ID# 237040
  • Headache Wellness Center /ID# 236431
  • Raleigh Neurology Associates /ID# 237141
  • Stetson-University of Cincinnati /ID# 236453
  • Abington Neurological Associates - Abington /ID# 236258
  • Preferred Primary Care Physicians, Inc. /ID# 236439
  • WR-ClinSearch /ID# 238288
  • Clinical Neuroscience Solutions - Memphis /ID# 237478
  • DiscoveResearch, Inc /ID# 236274
  • Texas Neurology /ID# 236359
  • University of Texas Southwestern Medical Center /ID# 236941
  • J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395
  • J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297
  • Highland Clinical Research /ID# 237816
  • MedStar Georgetown Neurology /ID# 236324
  • Sentara Neurology Specialists - Virginia Beach /ID# 234349
  • Northwest Clinical Research Center /ID# 237581
  • Puget Sound Neurology /ID# 236321
  • Royal North Shore Hospital /ID# 237008
  • The Royal Melbourne Hospital /ID# 236859
  • CHAMP Clinic /ID# 236252
  • Vancouver Island Health Authority /ID# 238053
  • Ottawa Headache Centre Research Inc /ID# 236432
  • Clinique des cephalees de Montreal /ID# 236266
  • Montreal Neurological Institut /ID# 236329
  • Peking University Third Hospital /ID# 238150
  • Chinese PLA General Hospital /ID# 238237
  • Guangzhou First People's Hospital /ID# 236510
  • The Second Affiliated Hospital of Guangzhou Medical University /ID# 238133
  • Hubei General Hospital /ID# 236486
  • The First Affiliated Hospital of Zhengzhou University /ID# 237025
  • Jiangsu Province Hospital /ID# 237846
  • The Second Hospital of Jilin University /ID# 236520
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 237847
  • The Second Hospital of Shanxi Medical University /ID# 236529
  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 238260
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 236500
  • Beijing Friendship Hospital /ID# 237264
  • The Second Hospital of Soochow University /ID# 234296
  • Tianjin Huanhu Hospital (THH) /ID# 236524
  • Tongji Hospital Tongji Medical College of HUST /ID# 237835
  • NEUROHK s.r.o. /ID# 236290
  • BRAIN-SOULTHERAPY s.r.o. /ID# 236380
  • CCR Ostrava, s.r.o. /ID# 234291
  • CLINTRIAL s.r.o. /ID# 237793
  • CCR Czech a.s /ID# 236249
  • FORBELI s.r.o. /ID# 236427
  • CCR Prague s.r.o. /ID# 236250
  • Thomayerova nemocnice /ID# 237175
  • NeuroMed Zlin s.r.o. /ID# 236416
  • Rigshospitalet Glostrup /ID# 236411
  • AP-HM - Hopital de la Timone /ID# 236285
  • CH Annecy Genevois Site Annecy /ID# 236385
  • Hôpital Pierre Wertheimer /ID# 236969
  • CHU Gabriel Montpied /ID# 237323
  • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256
  • Praxis Dr. Gendolla /ID# 236311
  • Universitaetsklinikum Essen /ID# 237209
  • CTC North GmbH & Co. KG /ID# 236328
  • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723
  • Schmerzklinik Kiel /ID# 236444
  • LMU Klinikum Campus Grosshadern /ID# 236293
  • Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492
  • Azienda Ospedaliero Universitaria Careggi /ID# 237598
  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291
  • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 236361
  • Universita di Pavia /ID# 236363
  • IRCCS San Raffaele Pisana /ID# 236552
  • Takanoko Hospital /ID# 234564
  • Fukuiken Saiseikai Hospital /ID# 236794
  • Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549
  • Konan Medical Center /ID# 236230
  • Atsuchi Neurosurgical Hospital /ID# 234779
  • Tokai University Hospital /ID# 237595
  • Fujitsu Clinic /ID# 237443
  • Umenotsuji Clinic /ID# 234495
  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496
  • Saitama Medical University Hospital /ID# 237019
  • Saitama Neuropsychiatric Institute /Id# 234550
  • Japanese Red Cross Shizuoka Hospital /ID# 234372
  • Dokkyo Medical University Hospital /ID# 236810
  • Niwa Family Clinic /ID# 234552
  • Tokyo Headache Clinic /ID# 234555
  • Keio University Hospital /ID# 237210
  • Nagaseki Headache Clinic /ID# 234561
  • DOI Internal Medicine-Neurology Clinic /ID# 234562
  • Hiroshima Neurology Clinic /ID# 234563
  • Tanaka Neurosurgical clinic /ID# 234760
  • Tatsuoka Neurology Clinic /ID# 234782
  • Tominaga Hospital /ID# 234781
  • Shinagawa Strings Clinic /ID# 234780
  • Dongtan Sacred Heart Hospital /ID# 238097
  • Kangbuk Samsung Hospital /ID# 237754
  • Yonsei University Health System Severance Hospital /ID# 237839
  • Pusan National University Hospital /ID# 237120
  • Nowon Eulji Medical Center, Eulji University /ID# 236306
  • Seoul National University Hospital /ID# 237786
  • Samsung Medical Center /ID# 237785
  • NZOZ Vitamed /ID# 237041
  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 236289
  • Specjalistyczne Gabinety Sp. z o.o. /ID# 236348
  • Centrum Leczenia Padaczki i Migreny /ID# 236386
  • Centrum Medyczne Pratia Gdynia /ID# 237077
  • Silmedic Sp. z o.o. /ID# 237343
  • Solumed Centrum Medyczne /ID# 236452
  • EuroMedis sp. z o.o. /ID# 236417
  • Kazan State Medical University /ID# 236298
  • State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 236354
  • University Headache Clinic /ID# 236371
  • Clinics Chaika /ID# 236394
  • Central Clinical Hospital RZHD Medicine /ID# 237024
  • Hospital Clínico Universitario de Santiago-CHUS /ID# 237623
  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645
  • Hospital Universitario Vall d'Hebron /ID# 236467
  • Hospital Universitario Virgen del Rocio /ID# 237106
  • Hospital Clinico Universitario de Valencia /ID# 237400
  • Hospital Universitario y Politecnico La Fe /ID# 237087
  • Hospital Clinico Universitario de Valladolid /ID# 234406
  • Hospital Clinico Universitario Lozano Blesa /ID# 237373
  • Stortorgets Neurologmottagning /ID# 236454
  • Kuang-Tien General Hospital /ID# 236309
  • Tainan Sin Lau Hospital /ID# 236358
  • Chi-Mei Medical Center /ID# 236724
  • Taipei Veterans General Hosp /ID# 237236
  • Tri-Service General Hospital /ID# 237657
  • Walton Centre /ID# 236468
  • King's College Hospital NHS Foundation Trust /ID# 236301

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Atogepant 30 mg BID

Atogepant 60 mg QD

Arm Description

Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.

Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.

Participants received atogepant 60 mg, orally, once daily (QD) along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period.

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.

Secondary Outcome Measures

Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population
Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. The values are rounded off to the first decimal value.
Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population
Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. The values are rounded off to the first decimal value.
Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12 in Off-Treatment Hypothetical Estimand Population
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population
The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population
The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand Population
HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses.

Full Information

First Posted
February 25, 2019
Last Updated
January 18, 2023
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03855137
Brief Title
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
January 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
778 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.
Arm Title
Atogepant 30 mg BID
Arm Type
Active Comparator
Arm Description
Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.
Arm Title
Atogepant 60 mg QD
Arm Type
Active Comparator
Arm Description
Participants received atogepant 60 mg, orally, once daily (QD) along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period.
Intervention Type
Drug
Intervention Name(s)
Atogepant 30 mg
Intervention Description
Tablets containing 30 mg atogepant
Intervention Type
Drug
Intervention Name(s)
Atogepant 60 mg
Intervention Description
Tablets containing 60 mg atogepant
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
30 mg/60 mg tablets containing atogepant-matching placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
Description
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population
Description
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population
Description
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population
Description
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population
Description
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population
Description
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Time Frame
Baseline to Week 12
Title
Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population
Description
Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. The values are rounded off to the first decimal value.
Time Frame
Baseline to Week 12
Title
Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population
Description
Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. The values are rounded off to the first decimal value.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12 in Off-Treatment Hypothetical Estimand Population
Description
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Time Frame
At Week 12
Title
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population
Description
The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population
Description
The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.
Time Frame
Baseline to Week 12
Title
Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand Population
Description
HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses.
Time Frame
At Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), 2018 Age of the participant at the time of migraine onset < 50 years Confirmation of headache/migraine headache day frequency as follows: History of, on average, ≥ 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND >=15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND >=8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary Participants must be using a medically acceptable and effective method of birth control during the course of the entire study Exclusion Criteria: Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 and Visit 2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neuro Institute /ID# 236776
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Baptist Health Center for Clinical Research /ID# 237361
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
California Headache and Balance Center /ID# 236246
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Wr-Pri Llc /Id# 236008
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Schuster Medical Research Institute /ID# 236447
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Alpine Clinical Research Center /ID# 234346
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-1880
Country
United States
Facility Name
George Washington University Medical Faculty Associates /ID# 238011
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037-3201
Country
United States
Facility Name
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709-3113
Country
United States
Facility Name
Accel Research Sites - Tampa Clinical Research Unit /ID# 237485
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Premiere Research Institute - Palm Beach /ID# 238192
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3209
Country
United States
Facility Name
NeuroTrials Research Inc. /ID# 237364
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Josephson-Wallack-Munshower Neurology - NE /ID# 238234
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256-4692
Country
United States
Facility Name
Collective Medical Research /ID# 236400
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Ochsner Clinic Foundation /ID# 236543
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433-8107
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 237540
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
BTC of New Bedford /ID# 236384
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Clinical Research Institute, Inc /ID# 238299
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402-2606
Country
United States
Facility Name
Headache Neurology Research Institute /ID# 236464
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Nevada Headache Institute /ID# 236420
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 237444
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc /ID# 236853
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albany Medical Center Rheumatology /ID# 236540
City
Albany
State/Province
New York
ZIP/Postal Code
12208-3412
Country
United States
Facility Name
Dent Neurosciences Research Center, Inc. /ID# 237040
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Headache Wellness Center /ID# 236431
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Raleigh Neurology Associates /ID# 237141
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Stetson-University of Cincinnati /ID# 236453
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Abington Neurological Associates - Abington /ID# 236258
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc. /ID# 236439
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
WR-ClinSearch /ID# 238288
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421-1605
Country
United States
Facility Name
Clinical Neuroscience Solutions - Memphis /ID# 237478
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
DiscoveResearch, Inc /ID# 236274
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Texas Neurology /ID# 236359
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
University of Texas Southwestern Medical Center /ID# 236941
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Highland Clinical Research /ID# 237816
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
MedStar Georgetown Neurology /ID# 236324
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States
Facility Name
Sentara Neurology Specialists - Virginia Beach /ID# 234349
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456-0019
Country
United States
Facility Name
Northwest Clinical Research Center /ID# 237581
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Puget Sound Neurology /ID# 236321
City
Tacoma
State/Province
Washington
ZIP/Postal Code
25328
Country
United States
Facility Name
Royal North Shore Hospital /ID# 237008
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
The Royal Melbourne Hospital /ID# 236859
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
CHAMP Clinic /ID# 236252
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Facility Name
Vancouver Island Health Authority /ID# 238053
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Ottawa Headache Centre Research Inc /ID# 236432
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
Clinique des cephalees de Montreal /ID# 236266
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1V1
Country
Canada
Facility Name
Montreal Neurological Institut /ID# 236329
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Peking University Third Hospital /ID# 238150
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Chinese PLA General Hospital /ID# 238237
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Guangzhou First People's Hospital /ID# 236510
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University /ID# 238133
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Facility Name
Hubei General Hospital /ID# 236486
City
Wuhan
State/Province
Hebei
ZIP/Postal Code
430060
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University /ID# 237025
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Jiangsu Province Hospital /ID# 237846
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The Second Hospital of Jilin University /ID# 236520
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130022
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 237847
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
The Second Hospital of Shanxi Medical University /ID# 236529
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 238260
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 236500
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Facility Name
Beijing Friendship Hospital /ID# 237264
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
The Second Hospital of Soochow University /ID# 234296
City
Suzhou
ZIP/Postal Code
215004
Country
China
Facility Name
Tianjin Huanhu Hospital (THH) /ID# 236524
City
Tianjin
ZIP/Postal Code
300350
Country
China
Facility Name
Tongji Hospital Tongji Medical College of HUST /ID# 237835
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
NEUROHK s.r.o. /ID# 236290
City
Hradec Kralove
ZIP/Postal Code
500 09
Country
Czechia
Facility Name
BRAIN-SOULTHERAPY s.r.o. /ID# 236380
City
Kladno
ZIP/Postal Code
272 01
Country
Czechia
Facility Name
CCR Ostrava, s.r.o. /ID# 234291
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
CLINTRIAL s.r.o. /ID# 237793
City
Prague 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
CCR Czech a.s /ID# 236249
City
Prague 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
FORBELI s.r.o. /ID# 236427
City
Prague
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
CCR Prague s.r.o. /ID# 236250
City
Praha
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Thomayerova nemocnice /ID# 237175
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
NeuroMed Zlin s.r.o. /ID# 236416
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Rigshospitalet Glostrup /ID# 236411
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
AP-HM - Hopital de la Timone /ID# 236285
City
Marseille CEDEX 05
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13385
Country
France
Facility Name
CH Annecy Genevois Site Annecy /ID# 236385
City
PRINGY cedex
State/Province
Haute-Savoie
ZIP/Postal Code
74374
Country
France
Facility Name
Hôpital Pierre Wertheimer /ID# 236969
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHU Gabriel Montpied /ID# 237323
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Praxis Dr. Gendolla /ID# 236311
City
Essen
ZIP/Postal Code
45133
Country
Germany
Facility Name
Universitaetsklinikum Essen /ID# 237209
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
CTC North GmbH & Co. KG /ID# 236328
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723
City
Kassel
ZIP/Postal Code
34131
Country
Germany
Facility Name
Schmerzklinik Kiel /ID# 236444
City
Kiel
ZIP/Postal Code
24149
Country
Germany
Facility Name
LMU Klinikum Campus Grosshadern /ID# 236293
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi /ID# 237598
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 236361
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Universita di Pavia /ID# 236363
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
IRCCS San Raffaele Pisana /ID# 236552
City
Rome
ZIP/Postal Code
00163
Country
Italy
Facility Name
Takanoko Hospital /ID# 234564
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
790-0925
Country
Japan
Facility Name
Fukuiken Saiseikai Hospital /ID# 236794
City
Fukui-shi
State/Province
Fukui
ZIP/Postal Code
918-8235
Country
Japan
Facility Name
Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0003
Country
Japan
Facility Name
Konan Medical Center /ID# 236230
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
658-0064
Country
Japan
Facility Name
Atsuchi Neurosurgical Hospital /ID# 234779
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0842
Country
Japan
Facility Name
Tokai University Hospital /ID# 237595
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Fujitsu Clinic /ID# 237443
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
211-8588
Country
Japan
Facility Name
Umenotsuji Clinic /ID# 234495
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
780-8011
Country
Japan
Facility Name
Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
982-0014
Country
Japan
Facility Name
Saitama Medical University Hospital /ID# 237019
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Saitama Neuropsychiatric Institute /Id# 234550
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
338-8577
Country
Japan
Facility Name
Japanese Red Cross Shizuoka Hospital /ID# 234372
City
Shizuoka-shi
State/Province
Shizuoka
ZIP/Postal Code
420-0853
Country
Japan
Facility Name
Dokkyo Medical University Hospital /ID# 236810
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Niwa Family Clinic /ID# 234552
City
Chofu-shi
State/Province
Tokyo
ZIP/Postal Code
182-0006
Country
Japan
Facility Name
Tokyo Headache Clinic /ID# 234555
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
151-0051
Country
Japan
Facility Name
Keio University Hospital /ID# 237210
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Nagaseki Headache Clinic /ID# 234561
City
Kai-shi
State/Province
Yamanashi
ZIP/Postal Code
400-0124
Country
Japan
Facility Name
DOI Internal Medicine-Neurology Clinic /ID# 234562
City
Hiroshima
ZIP/Postal Code
730-0031
Country
Japan
Facility Name
Hiroshima Neurology Clinic /ID# 234563
City
Hiroshima
ZIP/Postal Code
732-0822
Country
Japan
Facility Name
Tanaka Neurosurgical clinic /ID# 234760
City
Kagoshima
ZIP/Postal Code
892-0844
Country
Japan
Facility Name
Tatsuoka Neurology Clinic /ID# 234782
City
Kyoto
ZIP/Postal Code
600-8811
Country
Japan
Facility Name
Tominaga Hospital /ID# 234781
City
Osaka
ZIP/Postal Code
556-0017
Country
Japan
Facility Name
Shinagawa Strings Clinic /ID# 234780
City
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
Facility Name
Dongtan Sacred Heart Hospital /ID# 238097
City
Hwaseong
State/Province
Gyeonggido
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital /ID# 237754
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital /ID# 237839
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 237120
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Nowon Eulji Medical Center, Eulji University /ID# 236306
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 237786
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 237785
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
NZOZ Vitamed /ID# 237041
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 236289
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Specjalistyczne Gabinety Sp. z o.o. /ID# 236348
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Centrum Leczenia Padaczki i Migreny /ID# 236386
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-209
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia /ID# 237077
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Silmedic Sp. z o.o. /ID# 237343
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Solumed Centrum Medyczne /ID# 236452
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-529
Country
Poland
Facility Name
EuroMedis sp. z o.o. /ID# 236417
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Kazan State Medical University /ID# 236298
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 236354
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
University Headache Clinic /ID# 236371
City
Moscow
ZIP/Postal Code
119221
Country
Russian Federation
Facility Name
Clinics Chaika /ID# 236394
City
Moscow
ZIP/Postal Code
125047
Country
Russian Federation
Facility Name
Central Clinical Hospital RZHD Medicine /ID# 237024
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Hospital Clínico Universitario de Santiago-CHUS /ID# 237623
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 236467
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 237106
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia /ID# 237400
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 237087
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clinico Universitario de Valladolid /ID# 234406
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa /ID# 237373
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Stortorgets Neurologmottagning /ID# 236454
City
Helsingborg
ZIP/Postal Code
252 20
Country
Sweden
Facility Name
Kuang-Tien General Hospital /ID# 236309
City
Taichung City
ZIP/Postal Code
433
Country
Taiwan
Facility Name
Tainan Sin Lau Hospital /ID# 236358
City
Tainan City
ZIP/Postal Code
70142
Country
Taiwan
Facility Name
Chi-Mei Medical Center /ID# 236724
City
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 237236
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Tri-Service General Hospital /ID# 237657
City
Taipei City
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Walton Centre /ID# 236468
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 236301
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit, please refer to the link below.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
33942560
Citation
Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.
Results Reference
derived
PubMed Identifier
33142014
Citation
Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.
Results Reference
derived
Links:
URL
http://rxabbvie.com
Description
Related Information

Learn more about this trial

Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

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