Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06241313

Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

Led by AbbVie · Updated on 2026-05-12

1300

Participants Needed

149

Research Sites

135 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly. Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world. All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24). There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.

CONDITIONS

Official Title

Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of migraine (with or without aura) for at least 12 months before screening
  • 2 to 8 moderate to severe migraine attacks per month in the 3 months before screening
  • Migraine started before age 50
  • Migraines last between 4 and 72 hours untreated or unsuccessfully treated
  • Migraine episodes separated by at least 48 hours without headache pain
Not Eligible

You will not qualify if you...

  • Average of 15 or more headache days per month in the 6 months before screening or current chronic migraine diagnosis
  • Required hospital or emergency room treatment for migraine attacks 3 or more times in the 6 months before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 149 locations

1

Universitair Ziekenhuis Antwerpen /ID# 257582

Edegem, Antwerpen, Belgium, 2650

Active, Not Recruiting

2

Universitair Ziekenhuis Brussel /ID# 257584

Jette, Brussels Capital, Belgium, 1090

Actively Recruiting

3

Cabinet Prive Dr Sava /ID# 257581

Saint-Nicolas, Liege, Belgium, 4420

Actively Recruiting

4

Jessa Ziekenhuis /ID# 257578

Hasselt, Limburg, Belgium, 3500

Active, Not Recruiting

5

AZ Sint-Jan Brugge /ID# 257585

Bruges, West-Vlaanderen, Belgium, 8000

Active, Not Recruiting

6

AZ Groeninge /ID# 257586

Kortrijk, Belgium, 8500

Actively Recruiting

7

H.-Hartziekenhuis Lier /ID# 257577

Lier, Belgium, 2500

Actively Recruiting

8

CHR de la Citadelle /ID# 257587

Liège, Belgium, 4000

Actively Recruiting

9

The first affiliated hospital of bengbu medical college /ID# 258758

Bengbu, Anhui, China, 233004

Completed

10

Beijing Friendship Hospital /ID# 258830

Beijing, Beijing Municipality, China, 100032

Completed

11

Xuanwu Hospital Capital Medical University /ID# 258510

Beijing, Beijing Municipality, China, 100053

Completed

12

Peking University Third Hospital /ID# 259573

Beijing, Beijing Municipality, China, 100191

Completed

13

Chinese PLA General Hospital /ID# 257540

Beijing, Beijing Municipality, China, 100853

Completed

14

Peking University First Hospital /ID# 258672

Xicheng District, Beijing Municipality, China, 100034

Completed

15

Fujian Medical University Union Hospital /ID# 259575

Fuzhou, Fujian, China, 350001

Completed

16

The First Affiliated Hospital of Xiamen University /ID# 259576

Xiamen, Fujian, China, 361003

Completed

17

Lanzhou University Second Hospital /ID# 259667

Lanzhou, Gansu, China, 730030

Completed

18

Guangzhou First People's Hospital /ID# 258656

Guangzhou, Guangdong, China, 510180

Completed

19

The Second Affiliated Hospital of Guangzhou Medical University /ID# 258638

Guangzhou, Guangdong, China, 510260

Completed

20

The University Of Hong Kong - Shenzhen Hospital /ID# 258462

Shenzhen, Guangdong, China, 518053

Completed

21

The Affiliated Hospital of Guizhou Medical University /ID# 259536

Guiyang, Guizhou, China, 550004

Completed

22

Hainan General Hospital /ID# 259548

Haikou, Hainan, China, 570311

Completed

23

Hebei General Hospital /ID# 258583

Shijiazhuang, Hebei, China, 500051

Completed

24

Zhengzhou People's Hospital /ID# 258670

Zhengzhou, Henan, China, 450012

Completed

25

The Second Xiangya Hospital Of Central South University /ID# 260623

Changsha, Hunan, China, 410011

Completed

26

The Third Xiangya Hospital of Central South University /ID# 258787

Changsha, Hunan, China, 410013

Completed

27

Zhuzhou Central Hospital /ID# 260076

Zhuzhou, Hunan, China, 412007

Completed

28

The Second Affiliated Hospital of Nanjing Medical University /ID# 258648

Nanjing, Jiangsu, China, 210011

Completed

29

The Second Affiliated Hospital of Soochow University /ID# 259551

Suzhou, Jiangsu, China, 215004

Completed

30

The First Affiliated Hospital of Soochow University /ID# 258783

Suzhou, Jiangsu, China, 215031

Completed

31

Jiangxi Pingxiang Peoples Hospital /ID# 258652

Pingxiang, Jiangxi, China, 337055

Completed

32

The First Hospital of Jilin University /ID# 259585

Changchun, Jilin, China, 130021

Completed

33

The Second hospital of Jilin university /ID# 258556

Changchun, Jilin, China, 130022

Completed

34

General Hospital of Northern Theater Command /ID# 259556

Shenyang, Liaoning, China, 110016

Completed

35

Shaanxi Provincial PeopleS Hospital /ID# 259529

Xi'an, Shaanxi, China, 710054

Completed

36

Second Hospital of Shanxi Medical University /ID# 259669

Taiyuan, Shanxi, China, 030001

Completed

37

West China Hospital, Sichuan University /ID# 258664

Chengdu, Sichuan, China, 610041

Completed

38

Tianjin Medical University General Hospital /ID# 259513

Tianjin, Tianjin Municipality, China, 300052

Completed

39

Tianjin People's Hospital /ID# 258625

Tianjin, Tianjin Municipality, China, 300120

Completed

40

The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 258860

Hangzhou, Zhejiang, China, 310009

Completed

41

The First Affiliated Hospital of Wenzhou Medical University /ID# 258939

Wenzhou, Zhejiang, China, 325000

Completed

42

Baotou Central Hospital /ID# 258786

Baotou, China, 014040

Completed

43

The first people's Hospital Affiliated to Shanghai Jiaotong University /ID# 259554

Shanghai, China, 200080

Completed

44

CCR Ostrava, s.r.o. /ID# 257743

Ostrava, Ostrava-mesto, Czechia, 702 00

Actively Recruiting

45

Fakultni Nemocnice Ostrava /ID# 259023

Ostrava, Ostrava-mesto, Czechia, 708 52

Actively Recruiting

46

Praglandia /ID# 257667

Prague, Praha 5, Czechia, 150 00

Actively Recruiting

47

NeuroHK s.r.o. /ID# 257671

Hradec Králové, Czechia, 500 09

Actively Recruiting

48

Clintrial s.r.o. /ID# 257663

Prague, Czechia, 100 00

Actively Recruiting

49

DADO MEDICAL s.r.o. /ID# 257672

Prague, Czechia, 120 00

Actively Recruiting

50

Axon Clinical, s.r.o. /ID# 259024

Prague, Czechia, 140 00

Actively Recruiting

51

Fakultni Thomayerova nemocnice /ID# 259021

Prague, Czechia, 140 59

Actively Recruiting

52

FORBELI s.r.o. /ID# 259019

Prague, Czechia, 160 00

Actively Recruiting

53

INEP medical s.r.o. /ID# 257669

Prague, Czechia, 186 00

Actively Recruiting

54

Vestra Clinics s.r.o. /ID# 259022

Rychnov nad Kněžnou, Czechia, 516 01

Actively Recruiting

55

Neuropraxis Muenchen Sued /ID# 258077

Unterhaching, Bavaria, Germany, 82008

Actively Recruiting

56

Kopfschmerzzentrum - Frankfurt /ID# 258019

Frankfurt am Main, Hesse, Germany, 65929

Actively Recruiting

57

Studienzentrum Nord-West /ID# 258024

Westerstede, Lower Saxony, Germany, 26655

Completed

58

Universitaetsklinikum Duesseldorf /ID# 258078

Düsseldorf, North Rhine-Westphalia, Germany, 40225

Completed

59

Ambenet Hausarztpraxis /ID# 258075

Leipzig, Saxony, Germany, 04107

Actively Recruiting

60

Schmerzklinik Kiel /ID# 258005

Kiel, Schleswig-Holstein, Germany, 24149

Completed

61

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 258076

Berlin, Germany, 10117

Actively Recruiting

62

Universitaetsklinikum Essen /ID# 258023

Essen, Germany, 45147

Completed

63

Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 258008

Kassel, Germany, 34131

Completed

64

Velocity Clinical Research /ID# 258020

Wiesbaden, Germany, 65189

Actively Recruiting

65

Jávorszky Ödön Kórház /ID# 258969

Vác, Pest County, Hungary, 2600

Completed

66

Cortex Study Center /ID# 259032

Budapest, Hungary, 1026

Actively Recruiting

67

Semmelweis Egyetem /ID# 258546

Budapest, Hungary, 1085

Actively Recruiting

68

Semmelweis Egyetem /ID# 258800

Budapest, Hungary, 1085

Completed

69

UNO Medical Trials /ID# 259186

Budapest, Hungary, 1135

Completed

70

S-Medicon Kft /ID# 258547

Budapest, Hungary, 1138

Actively Recruiting

71

Istituto Neurologico Mediterraneo Neuromed /ID# 258593

Pozzilli, Isernia, Italy, 86077

Actively Recruiting

72

ASL 1 Abruzzo - Ospedale SS. Filippo and Nicola /ID# 258590

Avezzano, L Aquila, Italy, 67051

Actively Recruiting

73

IRCCS Ospedale San Raffaele /ID# 258592

Milan, Milano, Italy, 20132

Actively Recruiting

74

Istituto Auxologico Italiano - Irccs /ID# 258623

Milan, Milano, Italy, 20145

Actively Recruiting

75

A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258591

Turin, Piedmont, Italy, 10126

Actively Recruiting

76

Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 261089

Bologna, Italy, 40126

Actively Recruiting

77

ASST degli Spedali Civili di Brescia /ID# 258594

Brescia, Italy, 25123

Actively Recruiting

78

ICOT Istituto Marco Pasquali /ID# 258621

Latina, Italy, 04100

Active, Not Recruiting

79

Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 258589

Pavia, Italy, 27100

Active, Not Recruiting

80

Fondazione Policlinico Universitario Campus Bio-Medico /ID# 258588

Roma, Italy, 00128

Actively Recruiting

81

Ospedale San Paolo - ASL2 /ID# 258622

Savona, Italy, 17100

Active, Not Recruiting

82

Tokyo Dental College Ichikawa General Hospital /ID# 259570

Ichikawa-shi, Chiba, Japan, 272-0824

Completed

83

Ikeda Neurosurgical Clinic /ID# 259085

Kasuga-shi, Fukuoka, Japan, 816-0824

Actively Recruiting

84

Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 262708

Sapporo, Hokkaido, Japan, 003-0003

Completed

85

Umenotsuji Clinic /ID# 258717

Kochi, Kochi, Japan, 780-8011

Completed

86

Sendai Headache and Neurology Clinic Medical Corporation /ID# 258862

Sendai, Miyagi, Japan, 982-0014

Actively Recruiting

87

Tominaga Clinic - Osaka /ID# 258553

Osaka, Osaka, Japan, 556-0015

Actively Recruiting

88

Usuda Clinic Of Internal Medicine /ID# 260422

Setagaya-ku, Tokyo, Japan, 156-0043

Active, Not Recruiting

89

Tokyo Headache Clinic /ID# 258534

Shibuya-ku, Tokyo, Japan, 151-0051

Actively Recruiting

90

Nagaseki Headache Clinic /ID# 259214

Kai, Yamanashi, Japan, 400-0124

Actively Recruiting

91

DOI Internal Medicine-Neurology Clinic /ID# 259009

Hiroshima, Japan, 730-0031

Actively Recruiting

92

Tatsuoka Neurology Clinic /ID# 258771

Kyoto, Japan, 600-8811

Completed

93

Solumed Centrum Medyczne /ID# 258288

Poznan, Greater Poland Voivodeship, Poland, 60-529

Actively Recruiting

94

Clinical Research Center Medic-R /ID# 258268

Poznan, Greater Poland Voivodeship, Poland, 60-848

Actively Recruiting

95

Vitamed Galaj i Cichomski Sp.j. /ID# 258278

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079

Actively Recruiting

96

Athleticomed Sp. z o.o /ID# 258253

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752

Actively Recruiting

97

Linden Sp. z o.o. sp.k. /ID# 258283

Krakow, Lesser Poland Voivodeship, Poland, 30-721

Actively Recruiting

98

Instytut Zdrowia Dr Boczarska Jedynak /ID# 258248

Oświęcim, Lesser Poland Voivodeship, Poland, 32-600

Actively Recruiting

99

Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 258281

Lublin, Lublin Voivodeship, Poland, 20-582

Actively Recruiting

100

Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 258250

Gdansk, Pomeranian Voivodeship, Poland, 80-546

Actively Recruiting

101

Silmedic Sp. z o.o. /ID# 258249

Katowice, Silesian Voivodeship, Poland, 40-282

Actively Recruiting

102

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 258287

Wroclaw, Poland, 52-210

Actively Recruiting

103

Unidade Local de Saude do Alto Ave, EPE /ID# 257986

Guimarães, Braga District, Portugal, 4835-044

Actively Recruiting

104

Unidade Local de Saude de Almada-Seixal, EPE /ID# 257987

Almada, Setúbal District, Portugal, 2805-267

Actively Recruiting

105

Hospital da Luz Lisboa /ID# 257983

Lisbon, Portugal, 1500-650

Actively Recruiting

106

Unidade Local de Saude de Santa Maria, EPE /ID# 257989

Lisbon, Portugal, 1649-035

Actively Recruiting

107

Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 258140

Porto, Portugal, 4099-003

Actively Recruiting

108

Unidade Local de Saude da Arrabida, EPE /ID# 258139

Setúbal, Portugal, 2910-446

Actively Recruiting

109

Univerzitna nemocnica - Nemocnica svateho Michala a.s. /ID# 257909

Bratislava, Bratislava Region, Slovakia, 811 08

Actively Recruiting

110

Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 257961

Bratislava, Bratislava Region, Slovakia, 811 09

Actively Recruiting

111

University Hospital Bratislava - Hospital ak. L. Derera /ID# 257947

Bratislava, Bratislava Region, Slovakia, 831 01

Actively Recruiting

112

Neurologicka a algeziologicka ambulancia, SANERA /ID# 259176

Prešov, Presov, Slovakia, 080 01

Actively Recruiting

113

MUDr. Beata Dupejova neurologicka ambulancia s.r.o. /ID# 257901

Banská Bystrica, Slovakia, 974 04

Actively Recruiting

114

Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 258315

Liptovský Mikuláš, Žilina Region, Slovakia, 031 23

Completed

115

Hallym University Dongtan Sacred Heart Hospital /ID# 257999

Hwaseong, Gyeonggido, South Korea, 18450

Actively Recruiting

116

Chonnam National University Hospital /ID# 259154

Gwangju, Jeonranamdo, South Korea, 61469

Actively Recruiting

117

Nowon Eulji Medical Center, Eulji University /ID# 258000

Seoul, Seoul Teugbyeolsi, South Korea, 01830

Actively Recruiting

118

Seoul National University Hospital /ID# 258002

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Actively Recruiting

119

Kangbuk Samsung Hospital /ID# 258001

Seoul, Seoul Teugbyeolsi, South Korea, 03181

Actively Recruiting

120

Yonsei University Health System Severance Hospital /ID# 257998

Seoul, South Korea, 03722

Actively Recruiting

121

Hospital Universitario Marques de Valdecilla /ID# 257658

Santander, Cantabria, Spain, 39008

Actively Recruiting

122

Clinica Universidad de Navarra - Pamplona /ID# 257656

Pamplona, Navarre, Spain, 31008

Completed

123

Hospital Universitario Vall de Hebron /ID# 257652

Barcelona, Spain, 08035

Actively Recruiting

124

Hospital Universitario La Paz /ID# 257654

Madrid, Spain, 28046

Actively Recruiting

125

Hospital Universitario Virgen del Rocio /ID# 257657

Seville, Spain, 41013

Actively Recruiting

126

Hospital Universitario y Politecnico La Fe /ID# 257655

Valencia, Spain, 46026

Actively Recruiting

127

Hospital Clinico Universitario de Valladolid /ID# 257653

Valladolid, Spain, 47003

Completed

128

Hospital Clinico Universitario Lozano Blesa /ID# 257661

Zaragoza, Spain, 50009

Completed

129

Skaneuro Privatmottagning /ID# 258833

Lund, Skåne County, Sweden, 227 33

Actively Recruiting

130

Karolinska Universitetssjukhuset - Huddinge /ID# 258837

Huddinge, Stockholm County, Sweden, 141 57

Completed

131

Neurology Clinic /ID# 258835

Stockholm, Stockholm County, Sweden, 114 33

Completed

132

Optimuskliniken /ID# 258834

Upplands Vasby, Stockholm County, Sweden, 194 61

Completed

133

CTC EbbePark Linkoping /ID# 261170

Linköping, Sweden, 582 13

Actively Recruiting

134

Kuang-Tien General Hospital /ID# 258063

Taichung, Taichung, Taiwan, 433

Completed

135

Taipei Veterans General Hospital /ID# 258062

Taipei City, Taipei, Taiwan, 11217

Actively Recruiting

136

China Medical University Hospital /ID# 258417

Taichung, Taiwan, 40447

Actively Recruiting

137

Tri-Service General Hospital /ID# 258064

Taipei, Taiwan, 11490

Actively Recruiting

138

Linkou Chang Gung Memorial Hospital /ID# 259171

Taoyuan City, Taiwan, 333

Actively Recruiting

139

St Pancras Clinical Research /ID# 277704

Chester, Cheshire, United Kingdom, CH2 1HX

Actively Recruiting

140

North Coast Medical Ltd - Newquay Health Centre /ID# 260019

Newquay, Cornwall, United Kingdom, TR7 1RU

Active, Not Recruiting

141

Ashgate Medical Practice /ID# 258923

Chesterfield, Derbyshire, United Kingdom, S40 4AA

Actively Recruiting

142

The Adam Practice /ID# 258190

Poole, Dorset, United Kingdom, BH15 4JQ

Actively Recruiting

143

Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 259384

Glasgow, Lanarkshire, United Kingdom, G51 4TF

Completed

144

Re:Cognition Health Birmingham /ID# 258186

Birmingham, United Kingdom, B16 8LT

Actively Recruiting

145

Re:Cognition Health Bristol /ID# 258187

Bristol, United Kingdom, BS32 4SY

Actively Recruiting

146

Re:Cognition Health - Guildford /ID# 258188

Guildford, United Kingdom, GU2 7YD

Completed

147

St Pancras Clinical Research /ID# 258183

London, United Kingdom, EC2Y 8EA

Actively Recruiting

148

The University of Nottingham Health Service /ID# 259380

Nottingham, United Kingdom, NG7 2QW

Actively Recruiting

149

Primary Care Sheffield /ID# 259448

Sheffield, United Kingdom, S9 4EU

Active, Not Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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