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A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine

Primary Purpose

Episodic Migraine, Chronic Migraine

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

About this trial

This is an interventional treatment trial for Episodic Migraine focused on measuring Episodic migraine, Chronic migraine

Eligibility Criteria

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

Inclusion Criteria:

- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.

Exclusion Criteria:

  • Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
  • Participants with an ECG indicating clinically significant abnormalities at Visit 1.
  • Participants with hypertension at Visit 1.
  • Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
  • Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Sites / Locations

  • Barrow Neurological Institute /ID# 228217
  • California Headache and Balance Center /ID# 226241
  • Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404
  • Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226433
  • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389
  • Excell Research, Inc /ID# 228390
  • Schuster Medical Research Institute /ID# 226246
  • Alpine Clinical Research Center /ID# 226203
  • Sensible Healthcare /ID# 226426
  • Accel Research Sites - Tampa Clinical Research Unit /ID# 226252
  • NeuroTrials Research Inc /ID# 226477
  • Allied Physicians - Fort Wayne Neurological Center /ID# 226390
  • Josephson-Wallack-Munshower Neurology - NE /ID# 226295
  • Collective Medical Research /ID# 226482
  • Ochsner Clinic Foundation /ID# 228220
  • Pharmasite Research, Inc. /ID# 226444
  • Beth Israel Deaconess Medical Center /ID# 228214
  • BTC of New Bedford /ID# 226289
  • Clinical Research Institute, Inc /ID# 226232
  • Headache Neurology Research Institute /ID# 226234
  • StudyMetrix Research /ID# 226296
  • Clinvest Research LLC /ID# 226275
  • Methodist Physicians Clinic /ID# 226422
  • Albuquerque Clinical Trials, Inc /ID# 226523
  • Albany Medical Center Rheumatology /ID# 228212
  • Headache Wellness Center /ID# 226233
  • CTI Clinical Research Center /ID# 226278
  • Stetson-University of Cincinnati /ID# 226326
  • Abington Neurological Associates - Abington /ID# 226449
  • Preferred Primary Care Physicians, Inc. /ID# 226447
  • Mount Vernon Clinical Research /ID# 226249
  • CNS Healthcare - Memphis /ID# 226254
  • FutureSearch Trials of Neurology /ID# 226424
  • Austin Clinical Trial Partners /ID# 228391
  • DiscoveResearch, Inc /ID# 226490
  • Texas Neurology /ID# 226425
  • LinQ Research, LLC /ID# 226391
  • J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248
  • J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328
  • Highland Clinical Research /ID# 226287
  • Sentara Family Medicine Physicians /ID# 226448
  • Northwest Clinical Research Center /ID# 226240
  • Puget Sound Neurology /ID# 226253
  • CHAMP Clinic /ID# 226256
  • Vancouver Island Health Authority /ID# 226255
  • Aggarwal and Associates Limited /ID# 226452
  • Ottawa Headache Centre Research Inc /ID# 226451
  • Diex Recherche Sherbrooke Inc. /ID# 226427
  • NEUROHK s.r.o. /ID# 226429
  • BRAIN-SOULTHERAPY s.r.o. /ID# 226394
  • CCR Ostrava, s.r.o. /ID# 228412
  • A-SHINE s.r.o. /ID# 226207
  • CLINTRIAL s.r.o. /ID# 228413
  • CCR Czech a.s /ID# 226393
  • FORBELI s.r.o. /ID# 228406
  • DADO MEDICAL s.r.o. /ID# 226421
  • CCR Prague s.r.o. /ID# 226406
  • Fakultni Thomayerova nemocnice /ID# 228409
  • INEP medical s.r.o. /ID# 228411
  • Vestra Clinics s.r.o. /ID# 226453
  • NeuroMed Zlin s.r.o. /ID# 228414
  • Rigshospitalet Glostrup /ID# 228417
  • CHU Nice - Hopital de Cimiez /ID# 228419
  • AP-HM - Hopital de la Timone /ID# 226407
  • CHU de SAINT ETIENNE - Hopital Nord /ID# 228418
  • Hôpital Pierre Wertheimer /ID# 226430
  • CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 226459
  • AP-HP - Hopital Lariboisière /ID# 226220
  • Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991
  • Praxis Dr. Gendolla /ID# 229988
  • Universitaetsklinikum Essen /ID# 229989
  • Klinische Forschung Hannover-Mitte GmbH /ID# 226305
  • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571
  • Schmerzklinik Kiel /ID# 226454
  • AmBeNet GmbH /ID# 226312
  • Neuropoint GmbH /ID# 226313
  • Neuropraxis Muenchen Sued /ID# 226309
  • Studienzentrum Nord-West /ID# 226310
  • Intermed GmbH /ID# 226307
  • Bugat Pal Korhaz /ID# 228429
  • Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226409
  • Clinexpert Kft /ID# 228431
  • S-Medicon Kft /ID# 228432
  • Ospedale Ss. Filippo e Nicola /ID# 228627
  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228630
  • Azienda Ospedaliero Universitaria Careggi /ID# 228624
  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625
  • Universita di Pavia /ID# 228628
  • IRCCS San Raffaele Pisana /ID# 228436
  • Dongtan Sacred Heart Hospital /ID# 226264
  • Kangbuk Samsung Hospital /ID# 226263
  • Yonsei University Health System Severance Hospital /ID# 226265
  • Pusan National University Hospital /ID# 231416
  • Nowon Eulji Medical Center, Eulji University /ID# 226261
  • Seoul National University Hospital /ID# 226199
  • Samsung Medical Center /ID# 226280
  • Canisius-Wilhelmina Ziekenhuis /ID# 226410
  • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456
  • NZOZ Vitamed /ID# 226416
  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412
  • Specjalistyczne Gabinety Sp. z o.o. /ID# 228631
  • Centrum Leczenia Padaczki i Migreny /ID# 226458
  • Centrum Medyczne Pratia Gdynia /ID# 226431
  • Silmedic Sp. z o.o. /ID# 226457
  • Solumed Centrum Medyczne /ID# 226298
  • EuroMedis sp. z o.o. /ID# 226413
  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417
  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335
  • Hospital Universitario Vall d'Hebron /ID# 226338
  • Hospital Universitario Virgen del Rocio /ID# 226333
  • Hospital Clinico Universitario de Valladolid /ID# 226330
  • Taipei Veterans General Hospital /ID# 226206
  • Kuang-Tien General Hospital /ID# 226259
  • Tainan Sin Lau Hospital /ID# 226229
  • Tri-Service General Hospital /ID# 228998
  • King's College Hospital NHS Foundation Trust /ID# 226524
  • Re:Cognition Health - London /ID# 231205

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atogepant 60 mg

Arm Description

Taken once daily

Outcomes

Primary Outcome Measures

Percentage of Participants with at Least 1 Treatment Emergent Adverse Event

Secondary Outcome Measures

Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)

Full Information

First Posted
December 21, 2020
Last Updated
March 22, 2023
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT04686136
Brief Title
A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
Official Title
A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
September 13, 2024 (Anticipated)
Study Completion Date
September 13, 2024 (Anticipated)

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 will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
596 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atogepant 60 mg
Arm Type
Experimental
Arm Description
Taken once daily
Intervention Type
Drug
Intervention Name(s)
Atogepant 60 mg
Intervention Description
Tablets containing 60 mg of Atogepant
Primary Outcome Measure Information:
Title
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Time Frame
156 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
Time Frame
156 weeks
Title
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
Time Frame
156 weeks
Title
Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
Time Frame
156 weeks
Title
Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
Description
A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)
Time Frame
156 weeks

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: - Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk. Exclusion Criteria: Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative. Participants with an ECG indicating clinically significant abnormalities at Visit 1. Participants with hypertension at Visit 1. Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded. Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
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 Neurological Institute /ID# 228217
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013-4407
Country
United States
Facility Name
California Headache and Balance Center /ID# 226241
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3500
Country
United States
Facility Name
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226433
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3500
Country
United States
Facility Name
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Excell Research, Inc /ID# 228390
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Schuster Medical Research Institute /ID# 226246
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Alpine Clinical Research Center /ID# 226203
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-1880
Country
United States
Facility Name
Sensible Healthcare /ID# 226426
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Accel Research Sites - Tampa Clinical Research Unit /ID# 226252
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
NeuroTrials Research Inc /ID# 226477
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Allied Physicians - Fort Wayne Neurological Center /ID# 226390
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Josephson-Wallack-Munshower Neurology - NE /ID# 226295
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256-4692
Country
United States
Facility Name
Collective Medical Research /ID# 226482
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Ochsner Clinic Foundation /ID# 228220
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433-8107
Country
United States
Facility Name
Pharmasite Research, Inc. /ID# 226444
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 228214
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
BTC of New Bedford /ID# 226289
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Clinical Research Institute, Inc /ID# 226232
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402-2606
Country
United States
Facility Name
Headache Neurology Research Institute /ID# 226234
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
StudyMetrix Research /ID# 226296
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Clinvest Research LLC /ID# 226275
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Methodist Physicians Clinic /ID# 226422
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc /ID# 226523
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albany Medical Center Rheumatology /ID# 228212
City
Albany
State/Province
New York
ZIP/Postal Code
12208-3412
Country
United States
Facility Name
Headache Wellness Center /ID# 226233
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
CTI Clinical Research Center /ID# 226278
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Stetson-University of Cincinnati /ID# 226326
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Abington Neurological Associates - Abington /ID# 226449
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc. /ID# 226447
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Mount Vernon Clinical Research /ID# 226249
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
CNS Healthcare - Memphis /ID# 226254
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Trials of Neurology /ID# 226424
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Austin Clinical Trial Partners /ID# 228391
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
DiscoveResearch, Inc /ID# 226490
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Texas Neurology /ID# 226425
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
LinQ Research, LLC /ID# 226391
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248
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# 226328
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Highland Clinical Research /ID# 226287
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Sentara Family Medicine Physicians /ID# 226448
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Northwest Clinical Research Center /ID# 226240
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Puget Sound Neurology /ID# 226253
City
Tacoma
State/Province
Washington
ZIP/Postal Code
25328
Country
United States
Facility Name
CHAMP Clinic /ID# 226256
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Facility Name
Vancouver Island Health Authority /ID# 226255
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Aggarwal and Associates Limited /ID# 226452
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Ottawa Headache Centre Research Inc /ID# 226451
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc. /ID# 226427
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
NEUROHK s.r.o. /ID# 226429
City
Hradec Kralove
ZIP/Postal Code
500 09
Country
Czechia
Facility Name
BRAIN-SOULTHERAPY s.r.o. /ID# 226394
City
Kladno
ZIP/Postal Code
272 01
Country
Czechia
Facility Name
CCR Ostrava, s.r.o. /ID# 228412
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
A-SHINE s.r.o. /ID# 226207
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
CLINTRIAL s.r.o. /ID# 228413
City
Prague 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
CCR Czech a.s /ID# 226393
City
Prague 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
FORBELI s.r.o. /ID# 228406
City
Prague
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
DADO MEDICAL s.r.o. /ID# 226421
City
Praha
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
CCR Prague s.r.o. /ID# 226406
City
Praha
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Fakultni Thomayerova nemocnice /ID# 228409
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
INEP medical s.r.o. /ID# 228411
City
Praha
ZIP/Postal Code
186 00
Country
Czechia
Facility Name
Vestra Clinics s.r.o. /ID# 226453
City
Rychnov nad Kneznou
ZIP/Postal Code
516 01
Country
Czechia
Facility Name
NeuroMed Zlin s.r.o. /ID# 228414
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Rigshospitalet Glostrup /ID# 228417
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
CHU Nice - Hopital de Cimiez /ID# 228419
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06000
Country
France
Facility Name
AP-HM - Hopital de la Timone /ID# 226407
City
Marseille CEDEX 05
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13385
Country
France
Facility Name
CHU de SAINT ETIENNE - Hopital Nord /ID# 228418
City
St. Priest En Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Facility Name
Hôpital Pierre Wertheimer /ID# 226430
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 226459
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
AP-HP - Hopital Lariboisière /ID# 226220
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Praxis Dr. Gendolla /ID# 229988
City
Essen
ZIP/Postal Code
45133
Country
Germany
Facility Name
Universitaetsklinikum Essen /ID# 229989
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Klinische Forschung Hannover-Mitte GmbH /ID# 226305
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571
City
Kassel
ZIP/Postal Code
34131
Country
Germany
Facility Name
Schmerzklinik Kiel /ID# 226454
City
Kiel
ZIP/Postal Code
24149
Country
Germany
Facility Name
AmBeNet GmbH /ID# 226312
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Neuropoint GmbH /ID# 226313
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Neuropraxis Muenchen Sued /ID# 226309
City
Unterhaching
ZIP/Postal Code
82008
Country
Germany
Facility Name
Studienzentrum Nord-West /ID# 226310
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Intermed GmbH /ID# 226307
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
Bugat Pal Korhaz /ID# 228429
City
Gyöngyös
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226409
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Clinexpert Kft /ID# 228431
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
S-Medicon Kft /ID# 228432
City
Budapest
ZIP/Postal Code
1138
Country
Hungary
Facility Name
Ospedale Ss. Filippo e Nicola /ID# 228627
City
Avezzano
State/Province
L Aquila
ZIP/Postal Code
67051
Country
Italy
Facility Name
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228630
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi /ID# 228624
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Universita di Pavia /ID# 228628
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
IRCCS San Raffaele Pisana /ID# 228436
City
Rome
ZIP/Postal Code
00163
Country
Italy
Facility Name
Dongtan Sacred Heart Hospital /ID# 226264
City
Hwaseong
State/Province
Gyeonggido
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital /ID# 226263
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital /ID# 226265
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 231416
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Nowon Eulji Medical Center, Eulji University /ID# 226261
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 226199
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 226280
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Canisius-Wilhelmina Ziekenhuis /ID# 226410
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456
City
Terneuzen
ZIP/Postal Code
4535 PA
Country
Netherlands
Facility Name
NZOZ Vitamed /ID# 226416
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# 226412
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Specjalistyczne Gabinety Sp. z o.o. /ID# 228631
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Centrum Leczenia Padaczki i Migreny /ID# 226458
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-209
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia /ID# 226431
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Silmedic Sp. z o.o. /ID# 226457
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Solumed Centrum Medyczne /ID# 226298
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-529
Country
Poland
Facility Name
EuroMedis sp. z o.o. /ID# 226413
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-111
Country
Poland
Facility Name
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417
City
Wroclaw
ZIP/Postal Code
52-210
Country
Poland
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 226338
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 226333
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valladolid /ID# 226330
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Taipei Veterans General Hospital /ID# 226206
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Kuang-Tien General Hospital /ID# 226259
City
Taichung City
ZIP/Postal Code
433
Country
Taiwan
Facility Name
Tainan Sin Lau Hospital /ID# 226229
City
Tainan City
ZIP/Postal Code
70142
Country
Taiwan
Facility Name
Tri-Service General Hospital /ID# 228998
City
Taipei City
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
King's College Hospital NHS Foundation Trust /ID# 226524
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Re:Cognition Health - London /ID# 231205
City
London
ZIP/Postal Code
W1G 9JF
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 https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=3101-312-002
Description
Related Info

Learn more about this trial

A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine

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