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Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

Primary Purpose

Migraine, With or Without Aura

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atogepant
Placebo-matching Atogepant
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine, With or Without Aura

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has at least a 1-year history of migraine with or without aura
  • Age of the patient at the time of migraine onset < 50 years
  • History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
  • Demonstrated compliance with e-diary

Exclusion Criteria:

  • Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine
  • Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • Difficulty distinguishing migraine headache from other headaches
  • Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
  • Has a history of hepatitis within previous 6 months
  • Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
  • Pregnant or nursing females

Sites / Locations

  • Achieve Clinical Research
  • Radiant Research, Inc.
  • The Research Center of Southern California, LLC
  • Neuro-Pain Medical Center, Inc
  • Irvine Center for Clinical Research
  • Downtown LA Research Center, Inc.
  • Excell Research
  • Artemis Institute for Clinical Research
  • Diablo Clinical Research Inc
  • Advanced Neurosciences Research
  • Hartford Headache Center
  • Associated Neurologists of Southern Connecticut, P. C.
  • Chase Medical Research, LLC
  • The George Washington University
  • Clinical Research South Florida
  • Infinity Clinical Research
  • Jacksonville Center for Clinical Research
  • Clinical Neuroscience Solutions Inc
  • Meridien Research
  • Suncoast Research
  • Renstar Medical Research
  • Clinical Neuroscience Solutions
  • Palm Beach Neurological Center / Advanced Research Consultants, Inc.
  • Suncoast Neuroscience Associates, Inc.
  • Infinity Clinical Research LLC
  • Meridien Research
  • Neurology Research Institute Palm Beach
  • Institute for Advanced Medical Research
  • Radiant Research
  • Atlanta Center for Medical Research
  • iResearch Atlanta, LLC
  • Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
  • Clinical Research Atlanta
  • Northwest Clinical Trials, Inc.
  • Healthcare Research Network II, LLC
  • Rowe Neurology Institute
  • Boston Clinical Trials Inc
  • Northeast Medical Research Associates, Inc.
  • Medvadis Research Corporation
  • New England Regional Headache Center
  • Michigan Head Pain and Neurological Institute
  • Clinical Research Institute, Inc.
  • Mercy Research
  • Clinvest
  • Quality Clinical Research, Inc
  • Altea Research Institute
  • Renown Institute for Neuroscience
  • Hassman Research Institute - NJ
  • Amici Clinical Research
  • DENT Neurosciences Research Center
  • Radiant Research, Inc.
  • Carolina Headache Institute
  • Wake Research Associates LLC
  • Ohio Clinical Research, LLC
  • IPS Research Company
  • Lynn Health Science Institute
  • Oregon Center for Clinical Investigations, Inc.
  • Lehigh Center For Clinical Research
  • Suburban Research Associates
  • Coastal Carolina Research Center
  • Cns Healthcare
  • Nashville Neuroscience Group
  • Tekton Research
  • DermResearch Inc
  • DiscoveResearch, Inc.
  • Synexus US, L.P. Formally known as Texas Pharmaceutical Research, LP, DBA Research Across America
  • Central Texas Neurology Consultant
  • Radiant Research, San Antonio Center for Clinical Research
  • Road Runner Research LTD
  • ClinPoint Trials, LLC
  • Advanced Clinical Research
  • Tidewater Integrated Medical Research
  • Northwest Clinical Research Center
  • Women's Clinical Research Center
  • Kingfisher Cooperative, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Atogepant 10 mg QD

Atogepant 30 mg QD

Atogepant 30 mg BID

Atogepant 60 mg QD

Atogepant 60 mg BID

Arm Description

Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.

Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.

Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.

Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.

Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.

Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days was 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. Negative change from Baseline indicates improvement.

Secondary Outcome Measures

Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period
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 qualified by duration and acute symptomatic medication use. The 4-week (monthly) headache days was 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. Negative change from Baseline indicates improvement.
Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days=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. Each 4-week period was averaged.
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period
Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The 4-week (monthly) acute medication use days was 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. A negative change from Baseline indicates improvement.

Full Information

First Posted
July 26, 2016
Last Updated
November 13, 2018
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02848326
Brief Title
Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention
Official Title
A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 6, 2016 (Actual)
Primary Completion Date
April 2, 2018 (Actual)
Study Completion Date
April 23, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, With or Without Aura

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
834 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.
Arm Title
Atogepant 10 mg QD
Arm Type
Experimental
Arm Description
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
Arm Title
Atogepant 30 mg QD
Arm Type
Experimental
Arm Description
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
Arm Title
Atogepant 30 mg BID
Arm Type
Experimental
Arm Description
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Arm Title
Atogepant 60 mg QD
Arm Type
Experimental
Arm Description
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
Arm Title
Atogepant 60 mg BID
Arm Type
Experimental
Arm Description
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Atogepant
Other Intervention Name(s)
AGN-241689
Intervention Description
Atogepant capsule.
Intervention Type
Drug
Intervention Name(s)
Placebo-matching Atogepant
Intervention Description
Placebo-matching atogepant capsule.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period
Description
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days was 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. Negative change from Baseline indicates improvement.
Time Frame
Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period
Description
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration and acute symptomatic medication use. The 4-week (monthly) headache days was 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. Negative change from Baseline indicates improvement.
Time Frame
Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Title
Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period
Description
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days=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. Each 4-week period was averaged.
Time Frame
Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Title
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period
Description
Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The 4-week (monthly) acute medication use days was 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. A negative change from Baseline indicates improvement.
Time Frame
Baseline (First 28 Days of Screening/Baseline Period) to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has at least a 1-year history of migraine with or without aura Age of the patient at the time of migraine onset < 50 years History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment Demonstrated compliance with e-diary Exclusion Criteria: Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy Difficulty distinguishing migraine headache from other headaches Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption Has a history of hepatitis within previous 6 months Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 Pregnant or nursing females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Trugman, MD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Achieve Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Radiant Research, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
The Research Center of Southern California, LLC
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Neuro-Pain Medical Center, Inc
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Irvine Center for Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Downtown LA Research Center, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Diablo Clinical Research Inc
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Advanced Neurosciences Research
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Hartford Headache Center
City
East Hartford
State/Province
Connecticut
ZIP/Postal Code
06118
Country
United States
Facility Name
Associated Neurologists of Southern Connecticut, P. C.
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
The George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Clinical Research South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Infinity Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Clinical Neuroscience Solutions Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Meridien Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Suncoast Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Clinical Neuroscience Solutions
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Palm Beach Neurological Center / Advanced Research Consultants, Inc.
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Suncoast Neuroscience Associates, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Infinity Clinical Research LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Neurology Research Institute Palm Beach
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Institute for Advanced Medical Research
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Radiant Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Northwest Clinical Trials, Inc.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Healthcare Research Network II, LLC
City
Blue Island
State/Province
Illinois
ZIP/Postal Code
60406
Country
United States
Facility Name
Rowe Neurology Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Boston Clinical Trials Inc
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Northeast Medical Research Associates, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Medvadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
New England Regional Headache Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinical Research Institute, Inc.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Mercy Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65806
Country
United States
Facility Name
Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Quality Clinical Research, Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Renown Institute for Neuroscience
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Hassman Research Institute - NJ
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Amici Clinical Research
City
Warren
State/Province
New Jersey
ZIP/Postal Code
07059
Country
United States
Facility Name
DENT Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Radiant Research, Inc.
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Carolina Headache Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Wake Research Associates LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Ohio Clinical Research, LLC
City
Willoughby Hills
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc.
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Lehigh Center For Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Cns Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Nashville Neuroscience Group
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
DermResearch Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
DiscoveResearch, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Synexus US, L.P. Formally known as Texas Pharmaceutical Research, LP, DBA Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Central Texas Neurology Consultant
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Radiant Research, San Antonio Center for Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Road Runner Research LTD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
ClinPoint Trials, LLC
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Tidewater Integrated Medical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Women's Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Kingfisher Cooperative, LLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32822633
Citation
Goadsby PJ, Dodick DW, Ailani J, Trugman JM, Finnegan M, Lu K, Szegedi A. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727-737. doi: 10.1016/S1474-4422(20)30234-9. Erratum In: Lancet Neurol. 2020 Nov;19(11):e10.
Results Reference
derived
Links:
URL
http://www.allerganclinicaltrials.com
Description
http://www.allerganclinicaltrials.com

Learn more about this trial

Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

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