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

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 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, diarrhea 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./Desert Clinical Research, LLC.
  • Xenoscience, Inc.
  • Clinical Research Advantage, Inc./Orange Grove Family Practice
  • Principals Research Group, Inc.
  • KLR Business Group, Inc. dba Arkansas Clinical Research
  • The Research Center of Southern California, LLC
  • Med Center
  • T. Joseph Raoof MD, Inc./Encino Research Center
  • Neurology Center of North Orange County
  • Behavioral Research Specialists, LLC
  • Prime Care Clinical Research
  • Collaborative Neuroscience Network, LLC.
  • Synergy San Diego
  • Newport Beach Clinical Research Associates, Inc.
  • North County Clinical Research
  • Medical Center for Clinical Research
  • CA Medical Clinic for Headache
  • Southern California Research LLC
  • Encompass Clinical Research
  • Alpine Clinical Research Center, Inc.
  • Colorado Springs Neurological Associates
  • Delta Waves, Inc
  • Denver Neurological Research
  • Associated Neurologists, P.C.
  • Associated Neurolgists of Southern Connecticut, PC
  • Sarkis Clinical Trials
  • CPI MD Clinical
  • Infinity Clinical Research, LLC
  • Clinical Neuroscience Solutions, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Palm Beach Neurological Center/Advanced Research Consultants, Inc.
  • Meridien Research
  • University of South Florida
  • Meridien Research
  • Neurology Research Institute
  • Midtown Neurology
  • Columbus Regional Research Institute
  • Clinical Research Atlanta
  • Great Lakes Clinical Trials
  • Deaconess Clinic, Medical Office Building 1 Research Institute
  • Rowe Neurology Institute
  • Kansas Institute of Research
  • College Park Family Care Center Physicians Group - Neurology Research Department
  • Kentucky Pediatric/Adult Research
  • Pharmasite Research, Inc.
  • Boston Clinical Trials
  • Northeast Medical Research Associates, Inc
  • MedVadis Research Corporation
  • Michigan Head-Pain & Neurological Institute
  • Beyer Research
  • Clinical Research Institute, Inc.
  • Olive Branch Family Medical Center
  • Clinvest Research, LLC
  • Quality Clinical Research, Inc.
  • Clinical Research Advantage, Inc./Diagnostic Center of Medicine - Durango
  • Albuquerque Clinical Trials, Inc.
  • Albuquerque Neuroscience, Inc.
  • Regional Clinical Research, Inc.
  • Central New York Clinical Research
  • Rochester Clinical Research, Inc.
  • Neurology Associates, P.A.
  • Wake Research Associates, LLC
  • PMG Research of Winston-Salem, LLC.
  • Neuro-Behavioral Clinical Research, Inc.
  • CTI Clinical Research Center
  • Aventiv Research, Inc
  • Ohio Clinical Research, LLC
  • MPH IPS Research Company
  • NPC Research
  • Lynn Health Science Institute
  • Summit Research Network
  • Oregon Center For Clinical Investigations Inc. (OCCI, Inc.)
  • Clinical Research of Philadelphia, LLC
  • BTC of Lincoln
  • WR-ClinSearch, LLC
  • Holston Medical Group
  • Clinical Neuroscience Solutions, Inc.
  • FutureSearch Trials of Neurology
  • Tekton Research, Inc.
  • FutureSearch Trials of Dallas, LP
  • Red Star Research, LLC
  • Clinical Trials Texas, Inc
  • Road Runner Research, Ltd.
  • J. Lewis Research, Inc. / Foothill Family Clinic Draper
  • Granger Medical Clinic-Riverton
  • Optimum Clinical Research, Inc.
  • Highland Clinical Research
  • Tidewater Integrated Medical Research
  • Northwest Clinical Research Center
  • The Polyclinic Madison Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ubrogepant 50 mg

Ubrogepant 100 mg

Placebo

Arm Description

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

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

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

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 severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an 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.

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 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 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
July 7, 2016
Last Updated
December 13, 2018
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02828020
Brief Title
Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
Acronym
ACHIEVE I
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
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 22, 2016 (Actual)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
December 14, 2017 (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 (50 and 100 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
1672 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ubrogepant 50 mg
Arm Type
Experimental
Arm Description
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Arm Title
Ubrogepant 100 mg
Arm Type
Experimental
Arm Description
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Intervention Type
Drug
Intervention Name(s)
Ubrogepant
Intervention Description
50 mg 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 severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an 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.
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 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 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 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, diarrhea 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./Desert Clinical Research, LLC.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Xenoscience, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Clinical Research Advantage, Inc./Orange Grove Family Practice
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Principals Research Group, Inc.
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71901
Country
United States
Facility Name
KLR Business Group, Inc. dba Arkansas Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
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
Med Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
T. Joseph Raoof MD, Inc./Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Prime Care Clinical Research
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92656
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Synergy San Diego
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Newport Beach Clinical Research Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
North County Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92054
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
CA Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Southern California Research LLC
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Alpine Clinical Research Center, Inc.
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Delta Waves, Inc
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Denver Neurological Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Associated Neurologists, P.C.
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Associated Neurolgists of Southern Connecticut, PC
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
CPI MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
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
Meridien Research
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Neurology Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Midtown Neurology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Deaconess Clinic, Medical Office Building 1 Research Institute
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
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
College Park Family Care Center Physicians Group - Neurology Research Department
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Kentucky Pediatric/Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Pharmasite Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Northeast Medical Research Associates, Inc
City
South 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
Michigan Head-Pain & 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 Research, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Clinical Research Advantage, Inc./Diagnostic Center of Medicine - Durango
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Regional Clinical Research, Inc.
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
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, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Neurology Associates, P.A.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Aventiv Research, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Ohio Clinical Research, LLC
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
MPH IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
NPC Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
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. (OCCI, Inc.)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
BTC of Lincoln
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
WR-ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
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
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Red Star Research, LLC
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Clinical Trials Texas, Inc
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
78249
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
Granger Medical Clinic-Riverton
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Facility Name
Optimum Clinical Research, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
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
The Polyclinic Madison Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
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
31800988
Citation
Dodick DW, Lipton RB, Ailani J, Lu K, Finnegan M, Trugman JM, Szegedi A. Ubrogepant for the Treatment of Migraine. N Engl J Med. 2019 Dec 5;381(23):2230-2241. doi: 10.1056/NEJMoa1813049.
Results Reference
derived
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

Learn more about this trial

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

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