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Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

Primary Purpose

Episodic Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Standard of Care (SOC) Migraine Preventive Medication
Atogepant
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Migraine

Eligibility Criteria

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

Inclusion Criteria:

  • Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
  • Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
  • Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
  • At least a 1-year history of migraine with or without aura consistent with a diagnosis
  • Age of the participant at the time of migraine onset < 50 years
  • History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Exclusion Criteria:

  • Difficulty distinguishing migraine headaches from tension-type or other headaches
  • Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
  • Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
  • ≥ 15 headache days per month on average across the 3 months prior to Visit 1
  • Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
  • Female participant 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
  • Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
  • Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
  • At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
  • History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.

Sites / Locations

  • Clinical Research Advantage, Inc./Simon Williamson Clinic, PC
  • Achieve Clinical Research, LLC
  • Synexus Clinical Research US, Inc./East Valley Family Physicians PLC
  • Synexus Clinical Research US, Inc./Desert Clinical Research, LLC
  • Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC
  • Anaheim Clinical Trials, LLC
  • Hope Clinical Research
  • Pharmacology Research Institute
  • Sun Valley Research Center, Inc.
  • Irvine Center for Clinical Research
  • Grossmont Center for Clinical Research
  • Synergy San Diego
  • Collaborative Neuroscience Network, LLC.
  • Pharmacology Research Institute
  • Pacific Research Partners, LLC
  • Excell Research, Inc.
  • Desert Valley Research
  • Medical Center for Clinical Research
  • California Research Foundation
  • Artemis Institute for Clinical Research
  • California Medical Clinic for Headache
  • Encompass Clinical Research
  • Synexus Clinical Research US, Inc.
  • Diablo Clinical Research, Inc
  • Delta Waves, Inc.
  • Advanced Neurosciences Research, LLC
  • MD Clinical
  • Infinity Clinical Research
  • Clinical Neuroscience Solutions
  • Health Awareness, Inc.
  • Meridien Research
  • Well Pharma Medical Research, Corp.
  • Sensible Healthcare LLC
  • Clinical Neuroscience Solutions, Inc
  • Bioclinica Research
  • Infinity Clinical Research LLC
  • Meridien Research
  • Premiere Research Institute
  • Palm Beach Research Center
  • Synexus Clinical Research US, Inc.
  • Atlanta Center for Clinical Research
  • Columbus Regional Research Institute
  • iResearch Atlanta
  • Clinical Research Atlanta
  • Northwest Clinical Trials
  • Advanced Clinical Research
  • Evanston Premier Healthcare Research LLC
  • MidAmerica Neuroscience Research Foundation dba Rowe Neurology Institute
  • Kansas Institute of Research
  • Phoenix Medical Research, Inc.
  • Kentucky Pediatric Research
  • L-MARC Research Center
  • New Orleans Center for Clinical Research
  • Community Clinical Research Network
  • Michigan Headache & Neurological Institute
  • Beyer Research
  • Clinical Research Institute, Inc.
  • Olive Branch Family Medical Center
  • ClinVest
  • Meridian Clinical Research, LLC
  • Quality Clinical Research
  • Meridian Clinical Research, LLC
  • Synexus Clinical Research US, Inc
  • Altea Research Institute
  • Hassman Research Institutes
  • Amici Clinical Research
  • Princeton Center for Clinical Research
  • Bio Behavioral Health
  • Albuquerque Clinical Trials, Inc.
  • Dent Neurosciences Research Center
  • Regional Clinical Research, Inc.
  • Synexus Clinical Research US, Inc.
  • Central New York Clinical Research
  • Rochester Clinical Research
  • Upstate Clinical Research Associates, LLC
  • Plains Clinical Medical Clinic, LLC
  • Synexus Clinical Research US, Inc.
  • Synexus Clinical Research US, Inc.
  • Rapid Medical Research, Inc.
  • Ohio Clinical Research, LLC
  • IPS Research Company
  • Lynn Health Science Institute
  • Summit Research Network
  • Oregon Center for Clinical Investigations, Inc.
  • Lehigh Center for Clinical Research
  • Suburban Research Associates
  • Clinical Research of Philadelphia, LLC
  • Frontier Clinical Research, LLC
  • Frontier Clinical Research, LLC
  • Radiant Research, Inc.
  • Coastal Carolina Research Center
  • Meridian Clinical Research, LLC
  • Volunteer Research Group
  • CNS Healthcare - Memphis
  • Trinity Clinical Research
  • FutureSearch Trials of Neurology
  • Tekton Research, Inc
  • DiscoveResearch, Inc.
  • FutureSearch Trials of Dallas, LP
  • Earle Research
  • Research Trials WorldWide, LLC
  • Synexus Clinical Research US, Inc.
  • ClinPoint Trials
  • J. Lewis Research, Inc./Foothill Family Clinic Draper
  • Advanced Research Institute
  • Advanced Clinical Research
  • Charlottesville Medical Research Center, LLC
  • Clinical Research Associates of Tidewater
  • Tidewater Integrated Medical Research
  • Northwest Clinical Research Center
  • Seattle Women's: Health, Research
  • SSM Dean Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oral SOC Migraine Preventive Medication

Atogepant 60 mg

Arm Description

Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.

Atogepant 60 mg tablet taken orally, once daily for 52 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.

Secondary Outcome Measures

Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator
Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported.
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator
A standard 12-lead ECG was performed. The investigator determined if the result was potentially clinically significant. Only categories with at least one participant are reported.
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Vital sign measurements included sitting and standing blood pressure (BP), sitting and standing pulse rate, respiratory rate, temperature, and body weight. The investigator determined if the results were clinically significant. Only categories with at least one participant are reported.
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was 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). Only the most severe suicidal ideation and the most severe suicidal behavior counted during the treatment period for at least 1 participant are reported.

Full Information

First Posted
September 25, 2018
Last Updated
May 20, 2021
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03700320
Brief Title
Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
Official Title
A Phase 3, Multicenter, Randomized, Open-label Study to Evaluate the Long-term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
May 21, 2020 (Actual)
Study Completion Date
May 21, 2020 (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 safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
744 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral SOC Migraine Preventive Medication
Arm Type
Active Comparator
Arm Description
Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
Arm Title
Atogepant 60 mg
Arm Type
Experimental
Arm Description
Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Standard of Care (SOC) Migraine Preventive Medication
Intervention Description
Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.
Intervention Type
Drug
Intervention Name(s)
Atogepant
Intervention Description
Atogepant tablets taken orally, once daily for 52 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.
Time Frame
From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator
Description
Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported.
Time Frame
From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Title
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator
Description
A standard 12-lead ECG was performed. The investigator determined if the result was potentially clinically significant. Only categories with at least one participant are reported.
Time Frame
Up to Week 52
Title
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Description
Vital sign measurements included sitting and standing blood pressure (BP), sitting and standing pulse rate, respiratory rate, temperature, and body weight. The investigator determined if the results were clinically significant. Only categories with at least one participant are reported.
Time Frame
From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up)
Title
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior
Description
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was 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). Only the most severe suicidal ideation and the most severe suicidal behavior counted during the treatment period for at least 1 participant are reported.
Time Frame
Up to Week 52

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: Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures. Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment. Participants must be using a medically acceptable and effective method of birth control during the course of the entire study, At least a 1-year history of migraine with or without aura consistent with a diagnosis Age of the participant at the time of migraine onset < 50 years History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 Exclusion Criteria: Difficulty distinguishing migraine headaches from tension-type or other headaches Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy ≥ 15 headache days per month on average across the 3 months prior to Visit 1 Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well Female participant 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 Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once. At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.
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
Clinical Research Advantage, Inc./Simon Williamson Clinic, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Synexus Clinical Research US, Inc./East Valley Family Physicians PLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Synexus Clinical Research US, Inc./Desert Clinical Research, LLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Sun Valley Research Center, Inc.
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Irvine Center for Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Grossmont Center for Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pacific Research Partners, LLC
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Excell Research, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Desert Valley Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92123-1881
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
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Diablo Clinical Research, Inc
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Delta Waves, Inc.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Advanced Neurosciences Research, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Infinity Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Clinical Neuroscience Solutions
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Meridien Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Well Pharma Medical Research, Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Sensible Healthcare LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
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
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Center for Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
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
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Evanston Premier Healthcare Research LLC
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
MidAmerica Neuroscience Research Foundation dba Rowe Neurology Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Kansas Institute of Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Phoenix Medical Research, Inc.
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Kentucky Pediatric Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Community Clinical Research Network
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
Country
United States
Facility Name
Michigan Headache & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Clinical Research Institute, Inc.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Olive Branch Family Medical Center
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
ClinVest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Hassman Research Institutes
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Amici Clinical Research
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
Princeton Center for Clinical Research
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Regional Clinical Research, Inc.
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Central New York Clinical Research
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Upstate Clinical Research Associates, LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Plains Clinical Medical Clinic, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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
73106
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
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
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Radiant Research, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
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
Meridian Clinical Research, LLC
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
CNS Healthcare - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Trinity Clinical Research
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Tekton Research, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
DiscoveResearch, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Earle Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Research Trials WorldWide, LLC
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
ClinPoint Trials
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165
Country
United States
Facility Name
J. Lewis Research, Inc./Foothill Family Clinic Draper
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Charlottesville Medical Research Center, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
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
Seattle Women's: Health, Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
SSM Dean Health Research
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33942560
Citation
Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.
Results Reference
derived
PubMed Identifier
33142014
Citation
Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.
Results Reference
derived

Learn more about this trial

Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

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