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An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

Primary Purpose

Migraine, With or Without Aura

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ubrogepant
Placebo-matching Ubrogepant
Usual Care
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 - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).

Exclusion Criteria:

  • Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities
  • Requirement for a medication during the study that is on the list of prohibited medications.

Sites / Locations

  • Radiant Research, Inc.
  • East Family Physicians PC/Radiant Research, Inc.
  • Desert Clinical Research /Radiant Research, Inc.
  • Xenoscience, Inc.
  • Central Phoenix Medical Clinic
  • Radiant Research Inc.
  • Orange Grove Family Practice/Radiant Research, Inc.
  • Principals Research Group, Inc.
  • Arkansas Clinical Research
  • Anaheim Clinical Trials, LLC
  • Axiom Research
  • Hope Clinical Research
  • Med Center Medical Clinic Carmichael
  • Axiom Research, LLC
  • Pharmacology Research Institute
  • Encino Research Center/T Joseph Raoof MD Inc
  • Neuro-Pain Medical Center, Inc
  • California Headache and Balance Center
  • Neurology Center of North Orange County
  • Behavioral Research Specialists, LLC
  • Sun Valley Research Center
  • Grossmont Center For Clinical Research
  • Collaborative Neuroscience Network, LLC
  • Pharmacology Research Institute
  • Pacific Institute of Medical Research
  • Synergy San Diego
  • Pharmacology Research Institute
  • Newport Beach Clinical Research Associates, Inc.
  • Rancho Cucamonga Clinical Research
  • Desert Valley Research
  • George J Rederich MD, Inc.
  • Artemis Institute For Clinical Research
  • Medical Center for Clinical Research
  • California Medical Clinic for Headache
  • Southern California Research Center
  • Encompass Clinical Research
  • Radiant Research
  • Alpine Clinical Research Center
  • Clinicos LLC
  • Colorado Springs Neurological Associates
  • Delta Waves, Inc
  • Denver Neurological Research
  • Summit Headache and Neurologic Institute
  • Advanced Neurosciences Research
  • Associated Neurologists, PC
  • Associated Neurologists of Southern Connecticut, PC
  • Aventura Neurological Associates, PA
  • Clinical Research South Florida
  • Avail Clinical Research
  • Sarkis Clinical Trials
  • Wilks & Safirstein MD PA D/B/A MD Clinical
  • Infinity Clinical Research
  • Broward Research
  • Clinical Neuroscience Solutions Inc
  • Health Awareness, Inc.
  • Neurology Associates, P.A.
  • Panax Clinical Research
  • LCC Medical Research
  • Well Pharma Medical Research
  • Suncoast Clinical Research, Inc.
  • Renstar Medical Research
  • Sensible Healthcare, LLC
  • Clinical Neuroscience Solutions, Inc - Memphis, TN
  • Palm Beach Neurological Center / Advanced Research Consultants, Inc.
  • Qps Mra, Llc
  • Meridien Research
  • University of South Florida
  • Meridien Research
  • Neurology Research Institute Palm Beach
  • Palm Beach Research Center
  • Midtown Neurology
  • NeuroTrials Research Inc
  • Columbus Regional Research Institute
  • Clinical Research Atlanta
  • Advanced Clinical Research
  • Michigan Ave. Internists /Radiant Research, Inc.
  • Cedar Crosse Research Center
  • Great Lakes Clinical Trials, LLC
  • Robbins Headache Clinic
  • Deaconess Clinic Inc.
  • Josephson Wallack Munshower Neurology, P.C.
  • Rowe Neurology Institute
  • College Park Family Care Center Physicians Group- Neurology Research Dept
  • Kansas Institute of Research
  • Kentucky Pediatric Research Inc
  • Norton Neurology Services
  • L-MARC Research Center
  • Pharma Site Research
  • Seton Medical Group
  • Boston Clinical Trials Inc
  • BTC of New Bedford
  • Northeast Medical Research Associates, Inc.
  • Beacon Clinical Research, LLC
  • Medvadis Research Corporation
  • New England Regional Headache Center
  • Michigan Head Pain & Neurological Institute
  • Quest Research Institute
  • Women's Health Care Specialists
  • The Minneapolis Clinic of Neurology, Ltd.
  • Clinical Research Institute, Inc.
  • Olive Branch Family Medical Center
  • The Headache Center
  • Clinvest
  • Prairie Fields Family Medicine
  • Clinical Research Advantage, Inc/Synexus USA
  • Quality Clinical Research, Inc.
  • Meridian Clinical Research
  • Diagnostic Center of Medicine - Durango / Radiant Research, Inc.
  • Princeton Medical Institute
  • Princeton Center for Clinical Research
  • Bio Behavioral Health
  • Albuquerque Clinical Trials, Inc.
  • Albuquerque Neuroscience, Inc.
  • DENT Neurosciences Research Center
  • Regional Clinical Research, Inc.
  • Central New York Clinical Research
  • Rochester Clinical Research, Inc.
  • Upstate Clinical Research Associates
  • Headache Wellness Center
  • Neurology Associates, P.A.
  • Lake Shore Clinical Research, LLC
  • Wake Research Associates LLC
  • PMG Research of Winston-Salem
  • Plains Clinical Research Center, LLC
  • Radiant Research, Inc.
  • Neuro-Behavioral Clinical Research, Inc
  • CTI Clinical Research Center
  • Sentral Clinical Research Services
  • Patient Priority Clinical Sites
  • University of cincinnati
  • CTI Clinical research Center
  • Radiant Research, Inc
  • Rapid Medical Research, Inc.
  • Ohio Clinical Research, LLC
  • Aventiv Research Inc.
  • IPS Research Company
  • NPC Research
  • Lynn Health Science Institute
  • Sooner Clinical Research Inc
  • Summit Research Network Inc.
  • Oregon Center For Clinical Investigations Inc
  • Clinical Research Philadelphia
  • Preferred Primary Care Physicians, Inc.
  • Preferred Primary Care Physicians
  • Lincoln Research
  • Radiant Research
  • Clinical Trials of South Carolina
  • Vista Clinical Research
  • Hillcrest Clinical Research LLC
  • Clinsearch, LLC
  • Middle Tennessee Clinical Research
  • Holston Medical Group, P.C.
  • New Orleans Center for Clinical Research
  • CNS Healthcare
  • Future Search Trials
  • Tekton Research
  • Texas Neurology, P.A.
  • Futuresearch Trials of Dallas, LP
  • Radiant Research, Inc.
  • Research Trials Worldwide, LLC
  • Red Star Research, LLC
  • Clinical Trials Texas, Inc
  • Road Runner Research
  • J. Lewis Research, Inc. / Foothill Family Clinic Draper
  • Advanced Research Institute
  • Granger Medical Clinic - Riverton
  • Optimum Clinical Research, Inc.
  • Highland Clinical Reserach
  • Charlottesville Medical Research Center, LLC
  • Clinical Research Associates Tidewater
  • Blue Ridge Research Center
  • Tidewater Integrated Medical Research
  • Sentara Neurology Specialists
  • Northwest Clinical Research Center
  • The Polyclinic
  • South Puget Sound Neurology
  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual Care

Ubrogepant 50 mg

Ubrogepant 100 mg

Arm Description

Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.

Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.

Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.

Outcomes

Primary Outcome Measures

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and 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. TEAEs are AEs with an onset that occurs after receiving study drug.

Secondary Outcome Measures

Number of Participants With Clinically Significant Laboratory Values
Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Number of Participants With Clinically Significant Vital Sign Measurements
Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"

Full Information

First Posted
August 16, 2016
Last Updated
August 23, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02873221
Brief Title
An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
Official Title
A Multicenter, Randomized, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 13, 2016 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
August 2, 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 long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.
Detailed Description
Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.

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
None (Open Label)
Allocation
Randomized
Enrollment
1254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
Arm Title
Ubrogepant 50 mg
Arm Type
Experimental
Arm Description
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
Arm Title
Ubrogepant 100 mg
Arm Type
Experimental
Arm Description
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
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
Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.
Intervention Type
Drug
Intervention Name(s)
Usual Care
Intervention Description
Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and 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. TEAEs are AEs with an onset that occurs after receiving study drug.
Time Frame
56 Weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Clinically Significant Laboratory Values
Description
Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Time Frame
56 Weeks
Title
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
Description
ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Time Frame
56 Weeks
Title
Number of Participants With Clinically Significant Vital Sign Measurements
Description
Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Time Frame
56 Weeks
Title
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
Description
On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"
Time Frame
56 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709). Exclusion Criteria: Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities Requirement for a medication during the study that is on the list of prohibited medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adele Thorpe
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
East Family Physicians PC/Radiant Research, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Desert Clinical Research /Radiant Research, Inc.
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
Central Phoenix Medical Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Radiant Research Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Orange Grove Family Practice/Radiant Research, Inc.
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
Arkansas Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
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
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
Med Center Medical Clinic Carmichael
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
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
Encino Research Center/T Joseph Raoof MD Inc
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Neuro-Pain Medical Center, Inc
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
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
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
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
90270
Country
United States
Facility Name
Pacific Institute of Medical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Synergy San Diego
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
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
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
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
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
Southern California Research Center
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
Radiant Research
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Clinicos LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
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
Summit Headache and Neurologic Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Advanced Neurosciences Research
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Associated Neurologists, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Associated Neurologists of Southern Connecticut, PC
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Aventura Neurological Associates, PA
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
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Wilks & Safirstein MD PA D/B/A 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
33021
Country
United States
Facility Name
Broward Research
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
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
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Well Pharma Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
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
34471
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 - Memphis, TN
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
Qps Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
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 Palm Beach
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
Midtown Neurology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
NeuroTrials Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Michigan Ave. Internists /Radiant Research, Inc.
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
Great Lakes Clinical Trials, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Robbins Headache Clinic
City
Riverwoods
State/Province
Illinois
ZIP/Postal Code
60015
Country
United States
Facility Name
Deaconess Clinic Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
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
Rowe Neurology Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
College Park Family Care Center Physicians Group- Neurology Research Dept
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Kansas Institute of Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Kentucky Pediatric Research Inc
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Norton Neurology 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
Pharma Site Research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Seton Medical Group
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Boston Clinical Trials Inc
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
BTC of New Bedford
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02470
Country
United States
Facility Name
Northeast Medical Research Associates, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Medvadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
New England Regional Headache Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Michigan Head Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Quest Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Women's Health Care Specialists
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
The Minneapolis Clinic of Neurology, Ltd.
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
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
The Headache Center
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Prairie Fields Family Medicine
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Clinical Research Advantage, Inc/Synexus USA
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Diagnostic Center of Medicine - Durango / Radiant Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
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
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
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
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
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Neurology Associates, P.A.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
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
Wake Research Associates LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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
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
Sentral Clinical Research Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Patient Priority Clinical Sites
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
University of cincinnati
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
Radiant Research, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
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
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Aventiv Research Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
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
Sooner Clinical Research Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Center For Clinical Investigations Inc
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Clinical Research Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
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
Lincoln Research
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Radiant Research
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
Clinsearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Middle Tennessee Clinical Research
City
Fayetteville
State/Province
Tennessee
ZIP/Postal Code
37334
Country
United States
Facility Name
Holston Medical Group, P.C.
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
CNS Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Future Search Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Neurology, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Futuresearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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
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
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
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
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 Reserach
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
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 Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Blue Ridge Research Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
Facility Name
Tidewater Integrated Medical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Sentara Neurology Specialists
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
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
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
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35977836
Citation
Lipton RB, Dodick DW, Goadsby PJ, Burstein R, Adams AM, Lai J, Yu SY, Finnegan M, Kuang AW, Trugman JM. Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain. Neurology. 2022 Oct 25;99(17):e1905-e1915. doi: 10.1212/WNL.0000000000201031. Epub 2022 Aug 17.
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
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

Learn more about this trial

An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

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