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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified December 2022 by Allergan
Sponsor
Allergan
Information Provided by (Responsible Party)
Allergan
Clinicaltrials.gov Identifier
NCT03855137
Other Study ID Numbers:
3101-303-002
First Submitted
February 24, 2019
First Posted
February 25, 2019
Results First Posted
January 17, 2023
Last Update Posted
February 13, 2023
Last Verified
December 2022

ClinicalTrials.gov processed this data on January 2023. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Chronic Migraine
Drug: PlaceboDrug: Atogepant 30 mgDrug: Atogepant 60 mg

Study Design

Study TypeInterventional
Actual Enrollment778 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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 Start DateMarch 10, 2019
Actual Primary Completion DateJanuary 19, 2022
Actual Study Completion DateJanuary 19, 2022

Groups and Cohorts

Group/CohortIntervention/Treatment
Placebo
Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.
Drug: Placebo
30 mg/60 mg tablets containing atogepant-matching placebo
Atogepant 30 mg BID
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.
Drug: Atogepant 30 mg
Tablets containing 30 mg atogepant
Atogepant 60 mg QD
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.
Drug: Atogepant 60 mg
Tablets containing 60 mg atogepant

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. 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
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsAllergan
Locations
Barrow Neuro Institute /ID# 236776 | Phoenix Arizona, United States, 85013Baptist Health Center for Clinical Research /ID# 237361 | Little Rock Arkansas, United States, 72205California Headache and Balance Center /ID# 236246 | Fresno California, United States, 93720Wr-Pri Llc /Id# 236008 | Los Alamitos California, United States, 90720Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692 | Newport Beach California, United States, 92660Schuster Medical Research Institute /ID# 236447 | Sherman Oaks California, United States, 91403Alpine Clinical Research Center /ID# 234346 | Boulder Colorado, United States, 80301-1880George Washington University Medical Faculty Associates /ID# 238011 | Washington D.C. District of Columbia, United States, 20037-3201Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161 | St. Petersburg Florida, United States, 33709-3113Accel Research Sites - Tampa Clinical Research Unit /ID# 237485 | Tampa Florida, United States, 33634Premiere Research Institute - Palm Beach /ID# 238192 | West Palm Beach Florida, United States, 33407-3209NeuroTrials Research Inc. /ID# 237364 | Atlanta Georgia, United States, 30328Josephson-Wallack-Munshower Neurology - NE /ID# 238234 | Indianapolis Indiana, United States, 46256-4692Collective Medical Research /ID# 236400 | Prairie Village Kansas, United States, 66208Ochsner Clinic Foundation /ID# 236543 | Covington Louisiana, United States, 70433-8107Beth Israel Deaconess Medical Center /ID# 237540 | Boston Massachusetts, United States, 02215-5400BTC of New Bedford /ID# 236384 | New Bedford Massachusetts, United States, 02740Clinical Research Institute, Inc /ID# 238299 | Minneapolis Minnesota, United States, 55402-2606Headache Neurology Research Institute /ID# 236464 | Ridgeland Mississippi, United States, 39157Nevada Headache Institute /ID# 236420 | Las Vegas Nevada, United States, 89113Dartmouth-Hitchcock Medical Center /ID# 237444 | Lebanon New Hampshire, United States, 03756Albuquerque Clinical Trials, Inc /ID# 236853 | Albuquerque New Mexico, United States, 87102Albany Medical Center Rheumatology /ID# 236540 | Albany New York, United States, 12208-3412Dent Neurosciences Research Center, Inc. /ID# 237040 | Amherst New York, United States, 14226Headache Wellness Center /ID# 236431 | Greensboro North Carolina, United States, 27405Raleigh Neurology Associates /ID# 237141 | Raleigh North Carolina, United States, 27607Stetson-University of Cincinnati /ID# 236453 | Cincinnati Ohio, United States, 45219Abington Neurological Associates - Abington /ID# 236258 | Abington Pennsylvania, United States, 19001Preferred Primary Care Physicians, Inc. /ID# 236439 | Pittsburgh Pennsylvania, United States, 15236WR-ClinSearch /ID# 238288 | Chattanooga Tennessee, United States, 37421-1605Clinical Neuroscience Solutions - Memphis /ID# 237478 | Memphis Tennessee, United States, 38119DiscoveResearch, Inc /ID# 236274 | Bryan Texas, United States, 77802Texas Neurology /ID# 236359 | Dallas Texas, United States, 75214University of Texas Southwestern Medical Center /ID# 236941 | Dallas Texas, United States, 75390-7208J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395 | Salt Lake City Utah, United States, 84109J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297 | Salt Lake City Utah, United States, 84121Highland Clinical Research /ID# 237816 | Salt Lake City Utah, United States, 84124MedStar Georgetown Neurology /ID# 236324 | McLean Virginia, United States, 22101Sentara Neurology Specialists - Virginia Beach /ID# 234349 | Virginia Beach Virginia, United States, 23456-0019Northwest Clinical Research Center /ID# 237581 | Bellevue Washington, United States, 98007Puget Sound Neurology /ID# 236321 | Tacoma Washington, United States, 25328Royal North Shore Hospital /ID# 237008 | St Leonards New South Wales, Australia, 2065The Royal Melbourne Hospital /ID# 236859 | Parkville Victoria, Australia, 3050CHAMP Clinic /ID# 236252 | Calgary Alberta, Canada, T3M 1M4Vancouver Island Health Authority /ID# 238053 | Victoria British Columbia, Canada, V8R 1J8Ottawa Headache Centre Research Inc /ID# 236432 | Ottawa Ontario, Canada, K2G 6E2Clinique des cephalees de Montreal /ID# 236266 | Montreal Quebec, Canada, H2W 1V1Montreal Neurological Institut /ID# 236329 | Montreal Quebec, Canada, H3A 2B4Peking University Third Hospital /ID# 238150 | Beijing Beijing Municipality, China, 100191Chinese PLA General Hospital /ID# 238237 | Beijing Beijing Municipality, China, 100853Guangzhou First People's Hospital /ID# 236510 | Guangzhou Guangdong, China, 510180The Second Affiliated Hospital of Guangzhou Medical University /ID# 238133 | Guangzhou Guangdong, China, 510260Hubei General Hospital /ID# 236486 | Wuhan Hebei, China, 430060The First Affiliated Hospital of Zhengzhou University /ID# 237025 | Zhengzhou Henan, China, 450052Jiangsu Province Hospital /ID# 237846 | Nanjing Jiangsu, China, 210029The Second Hospital of Jilin University /ID# 236520 | Changchun Jilin, China, 130022Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 237847 | Shanghai Shanghai Municipality, China, 200065The Second Hospital of Shanxi Medical University /ID# 236529 | Taiyuan Shanxi, China, 030000The second Affiliated hospital of Zhejiang University school of Medicine /ID# 238260 | Hangzhou Zhejiang, China, 310009Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 236500 | Hangzhou Zhejiang, China, 310020Beijing Friendship Hospital /ID# 237264 | Beijing , China, 100032The Second Hospital of Soochow University /ID# 234296 | Suzhou , China, 215004Tianjin Huanhu Hospital (THH) /ID# 236524 | Tianjin , China, 300350Tongji Hospital Tongji Medical College of HUST /ID# 237835 | Wuhan , China, 430030NEUROHK s.r.o. /ID# 236290 | Hradec Králové , Czechia, 500 09BRAIN-SOULTHERAPY s.r.o. /ID# 236380 | Kladno , Czechia, 272 01CCR Ostrava, s.r.o. /ID# 234291 | Ostrava , Czechia, 702 00CLINTRIAL s.r.o. /ID# 237793 | Prague , Czechia, 100 00CCR Prague s.r.o. /ID# 236250 | Prague , Czechia, 130 00CCR Czech a.s /ID# 236249 | Prague , Czechia, 140 00Thomayerova nemocnice /ID# 237175 | Prague , Czechia, 140 59FORBELI s.r.o. /ID# 236427 | Prague , Czechia, 160 00NeuroMed Zlin s.r.o. /ID# 236416 | Zlín , Czechia, 760 01Rigshospitalet Glostrup /ID# 236411 | Glostrup Municipality Capital Region, Denmark, 2600AP-HM - Hopital de la Timone /ID# 236285 | Marseille Bouches-du-Rhone, France, 13385CH Annecy Genevois Site Annecy /ID# 236385 | Pringy Haute-Savoie, France, 74374Hôpital Pierre Wertheimer /ID# 236969 | Bron , France, 69677CHU Gabriel Montpied /ID# 237323 | Clermont-Ferrand , France, 63000Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256 | Berlin , Germany, 13353Praxis Dr. Gendolla /ID# 236311 | Essen , Germany, 45133Universitaetsklinikum Essen /ID# 237209 | Essen , Germany, 45147CTC North GmbH & Co. KG /ID# 236328 | Hamburg , Germany, 20251Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723 | Kassel , Germany, 34131Schmerzklinik Kiel /ID# 236444 | Kiel , Germany, 24149LMU Klinikum Campus Grosshadern /ID# 236293 | München , Germany, 81377Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492 | Bari , Italy, 70124Azienda Ospedaliero Universitaria Careggi /ID# 237598 | Florence , Italy, 50134Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291 | Milan , Italy, 20133AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 236361 | Naples , Italy, 80138Universita di Pavia /ID# 236363 | Pavia , Italy, 27100IRCCS San Raffaele Pisana /ID# 236552 | Rome , Italy, 00163Takanoko Hospital /ID# 234564 | Matsuyama Ehime, Japan, 790-0925Fukuiken Saiseikai Hospital /ID# 236794 | Fukui-shi Fukui, Japan, 918-8235Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549 | Sapporo Hokkaido, Japan, 003-0003Konan Medical Center /ID# 236230 | Kobe Hyōgo, Japan, 658-0064Atsuchi Neurosurgical Hospital /ID# 234779 | Kagoshima Kagoshima-ken, Japan, 892-0842Tokai University Hospital /ID# 237595 | Isehara-shi Kanagawa, Japan, 259-1193Fujitsu Clinic /ID# 237443 | Kawasaki-shi Kanagawa, Japan, 211-8588Umenotsuji Clinic /ID# 234495 | Kochi Kochi, Japan, 780-8011Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496 | Sendai Miyagi, Japan, 982-0014Saitama Medical University Hospital /ID# 237019 | Iruma-gun Saitama, Japan, 350-0495Saitama Neuropsychiatric Institute /Id# 234550 | Saitama-shi Saitama, Japan, 338-8577Japanese Red Cross Shizuoka Hospital /ID# 234372 | Shizuoka Shizuoka, Japan, 420-0853Dokkyo Medical University Hospital /ID# 236810 | Shimotsuga-gun Tochigi, Japan, 321-0293Niwa Family Clinic /ID# 234552 | Chofu-shi Tokyo, Japan, 182-0006Tokyo Headache Clinic /ID# 234555 | Shibuya-ku Tokyo, Japan, 151-0051Keio University Hospital /ID# 237210 | Shinjuku-ku Tokyo, Japan, 160-8582Nagaseki Headache Clinic /ID# 234561 | Kai-shi Yamanashi, Japan, 400-0124DOI Internal Medicine-Neurology Clinic /ID# 234562 | Hiroshima , Japan, 730-0031Hiroshima Neurology Clinic /ID# 234563 | Hiroshima , Japan, 732-0822Tanaka Neurosurgical clinic /ID# 234760 | Kagoshima , Japan, 892-0844Tatsuoka Neurology Clinic /ID# 234782 | Kyoto , Japan, 600-8811Tominaga Hospital /ID# 234781 | Osaka , Japan, 556-0017Shinagawa Strings Clinic /ID# 234780 | Tokyo , Japan, 108-0075Solumed Centrum Medyczne /ID# 236452 | Poznan Greater Poland Voivodeship, Poland, 60-529NZOZ Vitamed /ID# 237041 | Bydgoszcz Kuyavian-Pomeranian Voivodeship, Poland, 85-079Specjalistyczne Gabinety Sp. z o.o. /ID# 236348 | Krakow Lesser Poland Voivodeship, Poland, 30-539Centrum Leczenia Padaczki i Migreny /ID# 236386 | Krakow Lesser Poland Voivodeship, Poland, 31-209Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 236289 | Lublin Lublin Voivodeship, Poland, 20-582Centrum Medyczne Pratia Gdynia /ID# 237077 | Gdynia Pomeranian Voivodeship, Poland, 81-338Silmedic Sp. z o.o. /ID# 237343 | Katowice Silesian Voivodeship, Poland, 40-282EuroMedis sp. z o.o. /ID# 236417 | Szczecin West Pomeranian Voivodeship, Poland, 70-111Kazan State Medical University /ID# 236298 | Kazan' Tatarstan, Respublika, Russia, 420012State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 236354 | Kazan' Tatarstan, Respublika, Russia, 420021University Headache Clinic /ID# 236371 | Moscow , Russia, 119221Clinics Chaika /ID# 236394 | Moscow , Russia, 125047Central Clinical Hospital RZHD Medicine /ID# 237024 | Moscow , Russia, 129128Dongtan Sacred Heart Hospital /ID# 238097 | Hwaseong Gyeonggido, South Korea, 18450Kangbuk Samsung Hospital /ID# 237754 | Seoul Seoul Teugbyeolsi, South Korea, 03181Yonsei University Health System Severance Hospital /ID# 237839 | Seoul Seoul Teugbyeolsi, South Korea, 03722Pusan National University Hospital /ID# 237120 | Busan , South Korea, 49241Nowon Eulji Medical Center, Eulji University /ID# 236306 | Seoul , South Korea, 01830Seoul National University Hospital /ID# 237786 | Seoul , South Korea, 03080Samsung Medical Center /ID# 237785 | Seoul , South Korea, 06351Hospital Clínico Universitario de Santiago-CHUS /ID# 237623 | Santiago de Compostela A Coruna, Spain, 15706CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645 | Pamplona Navarre, Spain, 31008Hospital Universitario Vall d'Hebron /ID# 236467 | Barcelona , Spain, 08035Hospital Universitario Virgen del Rocio /ID# 237106 | Seville , Spain, 41013Hospital Clinico Universitario de Valencia /ID# 237400 | Valencia , Spain, 46010Hospital Universitario y Politecnico La Fe /ID# 237087 | Valencia , Spain, 46026Hospital Clinico Universitario de Valladolid /ID# 234406 | Valladolid , Spain, 47003Hospital Clinico Universitario Lozano Blesa /ID# 237373 | Zaragoza , Spain, 50009Stortorgets Neurologmottagning /ID# 236454 | Helsingborg , Sweden, 252 20Kuang-Tien General Hospital /ID# 236309 | Taichung , Taiwan, 433Tainan Sin Lau Hospital /ID# 236358 | Tainan , Taiwan, 70142Chi-Mei Medical Center /ID# 236724 | Tainan , Taiwan, 71004Taipei Veterans General Hosp /ID# 237236 | Taipei , Taiwan, 11217Tri-Service General Hospital /ID# 237657 | Taipei , Taiwan, 11490Walton Centre /ID# 236468 | Liverpool , United Kingdom, L9 7LJKing's College Hospital NHS Foundation Trust /ID# 236301 | London , United Kingdom, SE5 9RS
Investigators
Study Director: ALLERGAN INC., Allergan
Study Documents (Full Text)
Documents provided by Allergan: Study Protocol  May 28, 2020Documents provided by Allergan: Statistical Analysis Plan  January 23, 2022