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

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT03855137
Collaborator
(none)
750
Enrollment
150
Locations
3
Arms
34.4
Actual Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study includes a 12-week treatment period.

Condition or Disease Intervention/Treatment Phase
  • Drug: Atogepant 30 mg
  • Drug: Atogepant 60 mg
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
750 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Mar 11, 2019
Actual Primary Completion Date :
Jan 20, 2022
Actual Study Completion Date :
Jan 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Atogepant 30 mg BID

Taken twice daily

Drug: Atogepant 30 mg
Tablets containing 30 mg atogepant
Active Comparator: Atogepant 60 mg

Taken once daily

Drug: Atogepant 60 mg
Tablets containing 60 mg atogepant
Placebo Comparator: Placebo

Taken twice daily

Drug: Placebo
30 mg/60 mg tablets containing atogepant-matching placebo

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in mean monthly migraine days across the treatment period [12 Weeks]

    Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date.

Secondary Outcome Measures

  1. Change from baseline in mean monthly headache days across the 12-week treatment period [12 Weeks]

    Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date.

  2. Change from baseline in mean monthly acute medication use days across the 12-week treatment period [12 Weeks]

    Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date.

  3. At least a 50% reduction in 3-month average of monthly migraine days [12 Weeks]

    Defined as participants with at least a 50% reduction from baseline in monthly migraine days

  4. Change from baseline in MSQ v2.1 Role Function-Restrictive domain score at Week 12 [12 Weeks]

    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 assesses how migraines limit one's daily social and work-related activities; Role Function Preventive assesses how migraines prevent these activities; and the Emotional Function domain assesses the emotions associated with migraines.

  5. Change from baseline in mean monthly Performance of Daily Activities domain score of the AIM-D across the 12-week treatment period. (Excluding participants from Europe & Canada) [12 Weeks]

    The Activity Impairment in Migraine-Diary (AIM-D) is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items).

  6. Change from baseline in mean monthly Physical Impairment domain score of the AIM-D across the 12-week treatment period. (Excluding participants from Europe & Canada) [12 Weeks]

    The Activity Impairment in Migraine-Diary (AIM-D) is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items).

  7. Change from baseline in the Headache Impact Test (HIT-6) total score at Week 12 (Participants in Europe and Canada only) [12 Weeks]

    The 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barrow Neuro Institute /ID# 236776 Phoenix Arizona United States 85013
2 Baptist Health Center for Clinical Research /ID# 237361 Little Rock Arkansas United States 72205
3 California Headache and Balance Center /ID# 236246 Fresno California United States 93720
4 Wr-Pri Llc /Id# 236008 Los Alamitos California United States 90720
5 Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692 Newport Beach California United States 92660
6 Schuster Medical Research Institute /ID# 236447 Sherman Oaks California United States 91403
7 Alpine Clinical Research Center /ID# 234346 Boulder Colorado United States 80301-1880
8 George Washington University Medical Faculty Associates /ID# 238011 Washington District of Columbia United States 20037-3201
9 Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161 Saint Petersburg Florida United States 33709-3113
10 Accel Research Sites - Tampa Clinical Research Unit /ID# 237485 Tampa Florida United States 33634
11 Premiere Research Institute - Palm Beach /ID# 238192 West Palm Beach Florida United States 33407-3209
12 NeuroTrials Research Inc. /ID# 237364 Atlanta Georgia United States 30328
13 Josephson-Wallack-Munshower Neurology - NE /ID# 238234 Indianapolis Indiana United States 46256-4692
14 Collective Medical Research /ID# 236400 Prairie Village Kansas United States 66208
15 Ochsner Clinic Foundation /ID# 236543 Covington Louisiana United States 70433-8107
16 Beth Israel Deaconess Medical Center /ID# 237540 Boston Massachusetts United States 02215-5400
17 BTC of New Bedford /ID# 236384 New Bedford Massachusetts United States 02740
18 Clinical Research Institute, Inc /ID# 238299 Minneapolis Minnesota United States 55402-2606
19 Headache Neurology Research Institute /ID# 236464 Ridgeland Mississippi United States 39157
20 Nevada Headache Institute /ID# 236420 Las Vegas Nevada United States 89113
21 Dartmouth-Hitchcock Medical Center /ID# 237444 Lebanon New Hampshire United States 03756
22 Albuquerque Clinical Trials, Inc /ID# 236853 Albuquerque New Mexico United States 87102
23 Albany Medical Center Rheumatology /ID# 236540 Albany New York United States 12208-3412
24 Dent Neurosciences Research Center, Inc. /ID# 237040 Amherst New York United States 14226
25 Headache Wellness Center /ID# 236431 Greensboro North Carolina United States 27405
26 Raleigh Neurology Associates /ID# 237141 Raleigh North Carolina United States 27607
27 Stetson-University of Cincinnati /ID# 236453 Cincinnati Ohio United States 45219
28 Abington Neurological Associates - Abington /ID# 236258 Abington Pennsylvania United States 19001
29 Preferred Primary Care Physicians, Inc. /ID# 236439 Pittsburgh Pennsylvania United States 15236
30 WR-ClinSearch /ID# 238288 Chattanooga Tennessee United States 37421-1605
31 Clinical Neuroscience Solutions - Memphis /ID# 237478 Memphis Tennessee United States 38119
32 DiscoveResearch, Inc /ID# 236274 Bryan Texas United States 77802
33 Texas Neurology /ID# 236359 Dallas Texas United States 75214
34 University of Texas Southwestern Medical Center /ID# 236941 Dallas Texas United States 75390-7208
35 J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395 Salt Lake City Utah United States 84109
36 J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297 Salt Lake City Utah United States 84121
37 Highland Clinical Research /ID# 237816 Salt Lake City Utah United States 84124
38 MedStar Georgetown Neurology /ID# 236324 McLean Virginia United States 22101
39 Sentara Neurology Specialists - Virginia Beach /ID# 234349 Virginia Beach Virginia United States 23456-0019
40 Northwest Clinical Research Center /ID# 237581 Bellevue Washington United States 98004
41 Puget Sound Neurology /ID# 236321 Tacoma Washington United States 25328
42 Royal North Shore Hospital /ID# 237008 St Leonards New South Wales Australia 2065
43 The Royal Melbourne Hospital /ID# 236859 Parkville Victoria Australia 3050
44 CHAMP Clinic /ID# 236252 Calgary Alberta Canada T3M 1M4
45 Vancouver Island Health Authority /ID# 238053 Victoria British Columbia Canada V8R 1J8
46 Ottawa Headache Centre Research Inc /ID# 236432 Ottawa Ontario Canada K2G 6E2
47 Clinique des cephalees de Montreal /ID# 236266 Montreal Quebec Canada H2W 1V1
48 Montreal Neurological Institut /ID# 236329 Montreal Quebec Canada H3A 2B4
49 Peking University Third Hospital /ID# 238150 Beijing Beijing China 100191
50 Chinese PLA General Hospital /ID# 238237 Beijing Beijing China 100853
51 The Second Affiliated Hospital of Guangzhou Medical University /ID# 238133 Guangzhou Guangdong China 510260
52 Hubei General Hospital /ID# 236486 Wuhan Hebei China 430060
53 The First Affiliated Hospital of Zhengzhou University /ID# 237025 Zhengzhou Henan China 450052
54 Jiangsu Province Hospital /ID# 237846 Nanjing Jiangsu China 210029
55 The Second Hospital of Jilin University /ID# 236520 Changchun Jilin China 130022
56 Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 237847 Shanghai Shanghai China 200065
57 The Second Hospital of Shanxi Medical University /ID# 236529 Taiyuan Shanxi China 030000
58 The second Affiliated hospital of Zhejiang University school of Medicine /ID# 238260 Hangzhou Zhejiang China 310009
59 Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 236500 Hangzhou Zhejiang China 310020
60 Beijing Friendship Hospital /ID# 237264 Beijing China 100032
61 The Second Hospital of Soochow University /ID# 234296 Suzhou China 215004
62 Tianjin Huanhu Hospital (THH) /ID# 236524 Tianjin China 300350
63 Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 237835 Wuhan China 430030
64 NEUROHK s.r.o. /ID# 236290 Hradec Kralove Czechia 500 09
65 BRAIN-SOULTHERAPY s.r.o. /ID# 236380 Kladno Czechia 272 01
66 CCR Ostrava, s.r.o. /ID# 234291 Ostrava Czechia 702 00
67 CLINTRIAL s.r.o. /ID# 237793 Prague 10 Czechia 100 00
68 CCR Czech a.s /ID# 236249 Prague 4 Czechia 140 00
69 FORBELI s.r.o. /ID# 236427 Prague Czechia 160 00
70 CCR Prague s.r.o. /ID# 236250 Praha Czechia 130 00
71 Thomayerova nemocnice /ID# 237175 Praha Czechia 140 59
72 NeuroMed Zlin s.r.o. /ID# 236416 Zlin Czechia 760 01
73 Rigshospitalet Glostrup /ID# 236411 Glostrup Hovedstaden Denmark 2600
74 AP-HM - Hopital de la Timone /ID# 236285 Marseille CEDEX 05 Bouches-du-Rhone France 13385
75 CH Annecy Genevois Site Annecy /ID# 236385 PRINGY cedex Haute-Savoie France 74374
76 Hôpital Pierre Wertheimer /ID# 236969 Bron France 69677
77 CHU Gabriel Montpied /ID# 237323 Clermont Ferrand France 63000
78 Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256 Berlin Germany 13353
79 Praxis Dr. Gendolla /ID# 236311 Essen Germany 45133
80 Universitaetsklinikum Essen /ID# 237209 Essen Germany 45147
81 CTC North GmbH & Co. KG /ID# 236328 Hamburg Germany 20251
82 Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723 Kassel Germany 34131
83 Schmerzklinik Kiel /ID# 236444 Kiel Germany 24149
84 LMU Klinikum Campus Grosshadern /ID# 236293 München Germany 81377
85 Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492 Bari Italy 70124
86 Azienda Ospedaliero Universitaria Careggi /ID# 237598 Florence Italy 50134
87 Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291 Milan Italy 20133
88 AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 236361 Napoli Italy 80138
89 Universita di Pavia /ID# 236363 Pavia Italy 27100
90 IRCCS San Raffaele Pisana /ID# 236552 Rome Italy 00163
91 Takanoko Hospital /ID# 234564 Matsuyama-shi Ehime Japan 790-0925
92 Fukuiken Saiseikai Hospital /ID# 236794 Fukui-shi Fukui Japan 918-8235
93 Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549 Sapporo-shi Hokkaido Japan 003-0003
94 Konan Medical Center /ID# 236230 Kobe-shi Hyogo Japan 658-0064
95 Mito Kyodo General Hospital /ID# 236800 Mito-shi Ibaraki Japan 310-0015
96 Atsuchi Neurosurgical Hospital /ID# 234779 Kagoshima-shi Kagoshima Japan 892-0842
97 Tokai University Hospital /ID# 237595 Isehara-shi Kanagawa Japan 259-1193
98 Fujitsu Clinic /ID# 237443 Kawasaki-shi Kanagawa Japan 211-8588
99 Umenotsuji Clinic /ID# 234495 Kochi-shi Kochi Japan 780-8011
100 Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496 Sendai-shi Miyagi Japan 982-0014
101 Saitama Medical University Hospital /ID# 237019 Iruma-gun Saitama Japan 350-0495
102 Saitama Neuropsychiatric Institute /Id# 234550 Saitama-shi Saitama Japan 338-8577
103 Japanese Red Cross Shizuoka Hospital /ID# 234372 Shizuoka-shi Shizuoka Japan 420-0853
104 Dokkyo Medical University Hospital /ID# 236810 Shimotsuga-gun Tochigi Japan 321-0293
105 Niwa Family Clinic /ID# 234552 Chofu-shi Tokyo Japan 182-0006
106 Tokyo Headache Clinic /ID# 234555 Shibuya-ku Tokyo Japan 151-0051
107 Keio University Hospital /ID# 237210 Shinjuku-ku Tokyo Japan 160-8582
108 Nagaseki Headache Clinic /ID# 234561 Kai-shi Yamanashi Japan 400-0124
109 DOI Internal Medicine-Neurology Clinic /ID# 234562 Hiroshima Japan 730-0031
110 Hiroshima Neurology Clinic /ID# 234563 Hiroshima Japan 732-0822
111 Tanaka Neurosurgical clinic /ID# 234760 Kagoshima Japan 892-0844
112 Tatsuoka Neurology Clinic /ID# 234782 Kyoto Japan 600-8811
113 Tominaga Hospital /ID# 234781 Osaka Japan 556-0017
114 Shinagawa Strings Clinic /ID# 234780 Tokyo Japan 108-0075
115 Dongtan Sacred Heart Hospital /ID# 238097 Hwaseong Gyeonggido Korea, Republic of 18450
116 Kangbuk Samsung Hospital /ID# 237754 Seoul Seoul Teugbyeolsi Korea, Republic of 03181
117 Yonsei University Health System Severance Hospital /ID# 237839 Seoul Seoul Teugbyeolsi Korea, Republic of 03722
118 Pusan National University Hospital /ID# 237120 Busan Korea, Republic of 49241
119 Nowon Eulji Medical Center, Eulji University /ID# 236306 Seoul Korea, Republic of 01830
120 Seoul National University Hospital /ID# 237786 Seoul Korea, Republic of 03080
121 Samsung Medical Center /ID# 237785 Seoul Korea, Republic of 06351
122 NZOZ Vitamed /ID# 237041 Bydgoszcz Kujawsko-pomorskie Poland 85-079
123 Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 236289 Lublin Lubelskie Poland 20-582
124 Specjalistyczne Gabinety Sp. z o.o. /ID# 236348 Krakow Malopolskie Poland 30-539
125 Centrum Leczenia Padaczki i Migreny /ID# 236386 Krakow Malopolskie Poland 31-209
126 Centrum Medyczne Pratia Gdynia /ID# 237077 Gdynia Pomorskie Poland 81-338
127 Silmedic Sp. z o.o. /ID# 237343 Katowice Slaskie Poland 40-282
128 Centrum Medyczne Solumed /ID# 236452 Poznan Wielkopolskie Poland 60-529
129 EuroMedis sp. z o.o. /ID# 236417 Szczecin Zachodniopomorskie Poland 70-111
130 Kazan State Medical University /ID# 236298 Kazan Tatarstan, Respublika Russian Federation 420012
131 State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 236354 Kazan Tatarstan, Respublika Russian Federation 420021
132 University Headache Clinic /ID# 236371 Moscow Russian Federation 119221
133 Clinics Chaika /ID# 236394 Moscow Russian Federation 125047
134 Central Clinical Hospital RZHD Medicine /ID# 237024 Moscow Russian Federation 129128
135 Hospital Clínico Universitario de Santiago-CHUS /ID# 237623 Santiago de Compostela A Coruna Spain 15706
136 CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645 Pamplona Navarra Spain 31008
137 Vall d'Hebron University Hospital /ID# 236467 Barcelona Spain 08035
138 Hospital Universitario Virgen del Rocio /ID# 237106 Sevilla Spain 41013
139 Hospital Clinico Universitario de Valencia /ID# 237400 Valencia Spain 46010
140 Hospital Universitario y Politecnico La Fe /ID# 237087 Valencia Spain 46026
141 Hospital Clinico Universitario de Valladolid /ID# 234406 Valladolid Spain 47003
142 Hospital Clinico Universitario Lozano Blesa /ID# 237373 Zaragoza Spain 50009
143 Stortorgets Neurologmottagning /ID# 236454 Helsingborg Sweden 252 20
144 Kuang-Tien General Hospital /ID# 236309 Taichung City Taiwan 433
145 Tainan Sin Lau Hospital /ID# 236358 Tainan City Taiwan 70142
146 Chi-Mei Medical Center /ID# 236724 Tainan Taiwan 71004
147 Taipei Veterans General Hosp /ID# 237236 Taipei City Taiwan 11217
148 Tri-Service General Hospital /ID# 237657 Taipei City Taiwan 11490
149 Walton Centre /ID# 236468 Liverpool United Kingdom L9 7LJ
150 King's College Hospital NHS Foundation Trusts /ID# 236301 London United Kingdom SE5 9RS

Sponsors and Collaborators

  • Allergan

Investigators

  • Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03855137
Other Study ID Numbers:
  • 3101-303-002
  • 2018-004337-32
  • NCT04961671
First Posted:
Feb 26, 2019
Last Update Posted:
Feb 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Migraine Disorders

Study Results

No Results Posted as of Feb 14, 2022