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Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (ACHIEVE II)

Primary Purpose

Migraine, With or Without Aura

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ubrogepant
Placebo-matching Ubrogepant
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version
  • Migraine onset before age 50
  • History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
  • History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months.

Exclusion Criteria:

  • Difficulty distinguishing migraine headache from tension-type other headaches
  • Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
  • Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
  • Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
  • Has a chronic non-headache pain condition requiring daily pain medication
  • 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 any prior gastrointestinal conditions (eg, diarrhoea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded
  • Has a history of hepatitis within previous 6 months.

Sites / Locations

  • Clinical Research Advantage, Inc./Simon Williamson Clinic
  • Clinical Research Advantage, Inc./East Valley Family Physicians, PLC
  • St. Joseph's Hospital & Medical Center - Barrow Neurologic Institute (BNI)
  • Clinical Research Advantage, Inc./Central Phoenix Medical Clinic, LLC
  • Mayo Clinic Arizona, May Clinic Scottsdale
  • Radiant Research Inc.
  • Anaheim Clinical Trials, LLC
  • Axiom Research, LLC
  • Hope Clinical Research
  • Axiom Research, LLC
  • Pharmacology Research Institute
  • Neuro-Pain Medical Center
  • California Headache and Balance Center
  • Sun Valley Research Center
  • Grossmont Center For Clinical Research
  • Pharmacology Research Institute
  • California Advanced Neurotherapeutic, Inc.
  • Cedars Sinai Pain Center
  • Pharmacology Research Institute
  • Rancho Cucamonga Clinical Research
  • Desert Valley Research
  • George J Rederich MD, Inc
  • Artemis Institute For Clinical Research
  • Clinical Research Advantage, Inc./Cassidy Medical Group-Vista
  • Clinicos, LLC
  • Colorado Neurological Institute
  • Advanced Neurosciences Research, LLC
  • Georgetown University Hospital
  • Radiant Clinical Research
  • Aventura Neurological Associates
  • Clinical Research South Florida
  • Avail Clinical Research, LLC
  • Broward Research Group
  • Health Awareness, Inc.
  • Neurology Associates, P.A.
  • Panax Clinical Research
  • LCC Medical Research Institute, LLC
  • Well Pharma Medical Research, Corp.
  • Suncoast Clinical Research
  • Renstar Medical Research
  • Sensible Healthcare, LLC
  • QPS MRA, LLC (Miami Research Associates)
  • Palm Beach Research Center
  • The Kaufmann Clinic, Inc.
  • NeuroTrials Research, Inc.
  • Advanced Clinical Research
  • Clinical Research Advantage, Inc./Michigan Avenue Internists
  • Cedar Crosse Research Center
  • Robbins Headache Clinic
  • Josephson Wallack Munshower Neurology P.C.
  • Norton Neurology Services MS Services
  • L-MARC Research Center
  • Seton Medical Group
  • Overlea Personal Physicians
  • BTC of New Bedford
  • Beacon Clinical Research, LLC
  • New England Regional Headache Center, Inc.
  • Quest Research Institute
  • Minneapolis Clinic of Neurology
  • The Headache Center
  • Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC
  • Clinical Research Advantage, Inc
  • Meridian Clinical Research, LLC
  • Hope Research Institute
  • Dartmouth-Hitchcock Medical Center
  • Princeton Medical Institute
  • Princeton Center for Clinical Research
  • Bio Behavioral Health
  • DENT Neurosciences Research Center
  • Cushing Neuroscience Institute North Shore-LIJ Medical Group
  • ProHealth Care Associates, LLP
  • Upstate Clinical Research Associates, LLC
  • Westchester Neuro. Const
  • Carolina Headache Institute
  • Headache Wellness Center, PC
  • Lake Shore Clinical Research, LLC
  • Raleigh Neurology Associates, PA
  • Plains Clinical Research Center, LLC
  • Radiant Research, Inc.
  • Sentral Clinical Research Services
  • Patient Priority Clinical Sites, LLC
  • University of Cincinnati Dept of Psychiatry & Behavioral Neuroscience
  • CTI Clinical Research Center
  • Rapid Medical Research, Inc.
  • The Cleveland Clinic Foundation
  • Sooner Clinical Research
  • Preferred Primary Care Physicians, Inc.
  • Preferred Primary Care Physicians
  • Abington Neurological Associates, Ltd.
  • Radiant Research, Inc.
  • Clinical Trials of South Carolina
  • Vista Clinical Research
  • Hillcrest Clinical Research, LLC
  • Middle Tennessee Clinical Research
  • Volunteer Research Group
  • Baptist Memorial Medical Group (Neurology Specialist - Headache Clinic)
  • Texas Neurology, P.A.
  • Radiant Research, Inc
  • Research Trials Worldwide, LLC
  • Advanced Research Institute
  • Charlottesville Medical Research Center, LLC
  • iNeuro Headache Specialist
  • Clinical Research Associates of Tidewater
  • Blue Ridge Research Center, LLC
  • Sentara Neurology Specialists
  • Summit Research Network Seattle, LLC
  • South Puget Sound Neurology
  • West Virginia University, Department of Neurology
  • Medical College of Wisconsin, Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ubrogepant 25 mg

Ubrogepant 50 mg

Placebo

Arm Description

1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.

1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.

1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.

Outcomes

Primary Outcome Measures

Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms assessed.

Secondary Outcome Measures

Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose
Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose
Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain relief from 2 to 24 hours after initial dose.
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose
Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain freedom from 2 to 24 hours after initial dose.
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose
Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose
Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.
Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose
Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.

Full Information

First Posted
August 12, 2016
Last Updated
March 1, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02867709
Brief Title
Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Acronym
ACHIEVE II
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 26, 2016 (Actual)
Primary Completion Date
January 25, 2018 (Actual)
Study Completion Date
February 26, 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 efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.

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
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1686 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ubrogepant 25 mg
Arm Type
Experimental
Arm Description
1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Arm Title
Ubrogepant 50 mg
Arm Type
Experimental
Arm Description
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Intervention Type
Drug
Intervention Name(s)
Ubrogepant
Intervention Description
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Intervention Type
Drug
Intervention Name(s)
Placebo-matching Ubrogepant
Intervention Description
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Primary Outcome Measure Information:
Title
Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Description
Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
Time Frame
Baseline (Predose) to 2 hours after initial dose
Title
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
Description
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms assessed.
Time Frame
Baseline (Predose) to 2 hours after initial dose
Secondary Outcome Measure Information:
Title
Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose
Description
Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.
Time Frame
Baseline (Predose) to 2 hours after initial dose
Title
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose
Description
Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain relief from 2 to 24 hours after initial dose.
Time Frame
2 to 24 hours after initial dose
Title
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose
Description
Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain freedom from 2 to 24 hours after initial dose.
Time Frame
2 to 24 hours after initial dose
Title
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose
Description
Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.
Time Frame
2 hours after initial dose
Title
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose
Description
Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.
Time Frame
2 hours after initial dose
Title
Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose
Description
Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.
Time Frame
2 hours after initial dose

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: At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version Migraine onset before age 50 History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months. Exclusion Criteria: Difficulty distinguishing migraine headache from tension-type other headaches Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy Required hospital treatment of a migraine attack 3 or more times in the previous 6 months Has a chronic non-headache pain condition requiring daily pain medication 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 any prior gastrointestinal conditions (eg, diarrhoea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded Has a history of hepatitis within previous 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adele Thorpe
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Advantage, Inc./Simon Williamson Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Clinical Research Advantage, Inc./East Valley Family Physicians, PLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
St. Joseph's Hospital & Medical Center - Barrow Neurologic Institute (BNI)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Clinical Research Advantage, Inc./Central Phoenix Medical Clinic, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Mayo Clinic Arizona, May Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Radiant Research Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Axiom Research, LLC
City
Apple Valley
State/Province
California
ZIP/Postal Code
92307
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Axiom Research, LLC
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
California Headache and Balance Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Sun Valley Research Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
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
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
California Advanced Neurotherapeutic, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Cedars Sinai Pain Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Rancho Cucamonga Clinical Research
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Desert Valley Research
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
George J Rederich MD, Inc
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Artemis Institute For Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Research Advantage, Inc./Cassidy Medical Group-Vista
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Clinicos, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Advanced Neurosciences Research, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Radiant Clinical Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Aventura Neurological Associates
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Clinical Research South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Broward Research Group
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Neurology Associates, P.A.
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
LCC Medical Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Well Pharma Medical Research, Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
QPS MRA, LLC (Miami Research Associates)
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
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
The Kaufmann Clinic, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Clinical Research Advantage, Inc./Michigan Avenue Internists
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60604
Country
United States
Facility Name
Cedar Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Robbins Headache Clinic
City
Riverwoods
State/Province
Illinois
ZIP/Postal Code
60015
Country
United States
Facility Name
Josephson Wallack Munshower Neurology P.C.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Norton Neurology Services MS Services
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Seton Medical Group
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Overlea Personal Physicians
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
BTC of New Bedford
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
New England Regional Headache Center, Inc.
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Quest Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
The Headache Center
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Clinical Research Advantage, Inc
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
Hope Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
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
DENT Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Cushing Neuroscience Institute North Shore-LIJ Medical Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
ProHealth Care Associates, LLP
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
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
Westchester Neuro. Const
City
Yonkers
State/Province
New York
ZIP/Postal Code
10701
Country
United States
Facility Name
Carolina Headache Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Headache Wellness Center, PC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Lake Shore Clinical Research, LLC
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Raleigh Neurology Associates, PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Plains Clinical Research Center, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Radiant Research, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Sentral Clinical Research Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Patient Priority Clinical Sites, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
University of Cincinnati Dept of Psychiatry & Behavioral Neuroscience
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Abington Neurological Associates, Ltd.
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Radiant Research, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Vista Clinical Research
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Hillcrest Clinical Research, LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Middle Tennessee Clinical Research
City
Fayetteville
State/Province
Tennessee
ZIP/Postal Code
37334
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Baptist Memorial Medical Group (Neurology Specialist - Headache Clinic)
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Neurology, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Radiant Research, Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Research Trials Worldwide, LLC
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Charlottesville Medical Research Center, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
iNeuro Headache Specialist
City
McLean
State/Province
Virginia
ZIP/Postal Code
22102
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Blue Ridge Research Center, LLC
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
Facility Name
Sentara Neurology Specialists
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Summit Research Network Seattle, LLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
South Puget Sound Neurology
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98409
Country
United States
Facility Name
West Virginia University, Department of Neurology
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Medical College of Wisconsin, Department of Neurology
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36125279
Citation
Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072.
Results Reference
derived
PubMed Identifier
35468729
Citation
Lipton RB, Singh RBH, Revicki DA, Zhao S, Shewale AR, Lateiner JE, Dodick DW. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: a post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials. J Headache Pain. 2022 Apr 25;23(1):50. doi: 10.1186/s10194-022-01419-7.
Results Reference
derived
PubMed Identifier
34874514
Citation
Blumenfeld AM, Knievel K, Manack Adams A, Severt L, Butler M, Lai H, Dodick DW. Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. Adv Ther. 2022 Jan;39(1):692-705. doi: 10.1007/s12325-021-01923-3. Epub 2021 Dec 7.
Results Reference
derived
PubMed Identifier
33874756
Citation
Hutchinson S, Silberstein SD, Blumenfeld AM, Lipton RB, Lu K, Yu SY, Severt L. Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II. Cephalalgia. 2021 Aug;41(9):979-990. doi: 10.1177/03331024211000311. Epub 2021 Apr 19.
Results Reference
derived
PubMed Identifier
33608814
Citation
Hutchinson S, Dodick DW, Treppendahl C, Bennett NL, Yu SY, Guo H, Trugman JM. Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. Neurol Ther. 2021 Jun;10(1):235-249. doi: 10.1007/s40120-021-00234-7. Epub 2021 Feb 20.
Results Reference
derived
PubMed Identifier
33241721
Citation
Goadsby PJ, Blumenfeld AM, Lipton RB, Dodick DW, Kalidas K, M Adams A, Jakate A, Liu C, Szegedi A, Trugman JM. Time course of efficacy of ubrogepant for the acute treatment of migraine: Clinical implications. Cephalalgia. 2021 Apr;41(5):546-560. doi: 10.1177/0333102420970523. Epub 2020 Nov 26.
Results Reference
derived
PubMed Identifier
31742631
Citation
Lipton RB, Dodick DW, Ailani J, Lu K, Finnegan M, Szegedi A, Trugman JM. Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1887-1898. doi: 10.1001/jama.2019.16711. Erratum In: JAMA. 2020 Apr 7;323(13):1318.
Results Reference
derived
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

Learn more about this trial

Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

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