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Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants (UBR Prodrome)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ubrogepant 100 mg
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine

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 ICHD-3 (International Classification of Headache Disorders 3rd edition)
  • Migraine onset before age 50 years
  • By history, the participant's migraines typically last 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 in each of the 3 months prior to the Screening Visit

Exclusion Criteria:

  • Difficulty distinguishing migraine headache from tension-type or other headaches
  • Participants who overuse medication for migraine defined as use of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment
  • Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3
  • A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or more headache days per month on average in the 6 months prior to Visit 1 in the investigator's judgment. A headache day is defined as a day in which there was any occurrence of a headache of a minimum duration of 2 hours or a headache of any duration for which acute medication was taken.
  • Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
  • Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Visit 1.
  • History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that, per investigator judgment, may affect the absorption or metabolism of the study intervention; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded

Sites / Locations

  • Achieve Clinical Research, LLC /ID# 237098
  • Barrow Neuro Institute /ID# 236775
  • Arkansas Clinical Research /ID# 238032
  • California Headache and Balance Center /ID# 236247
  • Sun Valley Research Center /ID# 236561
  • Wr-Pri Llc /Id# 236007
  • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691
  • Excell Research, Inc /ID# 237721
  • George J. Rederich M.D. Inc. /ID# 235769
  • Diablo Clinical Research /ID# 237570
  • Colorado Springs Neurological Associates (CSNA) /ID# 236556
  • Advanced Neurosciences Research, LLC /ID# 237426
  • CNS Healthcare - Jacksonville /ID# 238245
  • Health Awareness, Inc - Jupiter /ID# 236226
  • Suncoast Clinical Research /ID# 236934
  • Sensible Healthcare /ID# 238090
  • Clinical Neuroscience Solutions, Inc /ID# 236608
  • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163
  • University of South Florida /ID# 234387
  • ForCare Clinical Research /ID# 237092
  • Premiere Research Institute - Palm Beach /ID# 238193
  • NeuroTrials Research Inc. /ID# 237365
  • iResearch Atlanta, LLC /ID# 237390
  • Meridian Clinical Research (Neurology) - Savannah /ID# 234371
  • Clinical Research Atlanta - Headlands LLC /ID# 234438
  • Northwest Clinical Trials /ID# 234968
  • Deaconess Clinic Downtown /ID# 236959
  • PMG Research of McFarland /ID# 238271
  • Collective Medical Research /ID# 236402
  • Kansas Institute of Research /ID# 236738
  • Boston Clinical Trials /ID# 236559
  • Michigan Headache & Neurological Institute (MHNI) /ID# 236565
  • Minneapolis Clinic of Neurology - Golden Valley /ID# 238162
  • Clinical Research Institute, Inc /ID# 238301
  • StudyMetrix Research /ID# 236457
  • Clinvest Research LLC /ID# 237908
  • Princeton Center for Clinical Research /ID# 235734
  • Bio Behavioral Health, Inc /ID# 238212
  • Dent Neurosciences Research Center, Inc. /ID# 237039
  • Central New York Clinical Research /ID# 235694
  • Rochester Clinical Research /ID# 236842
  • Upstate Clinical Research Associates /ID# 238220
  • PMG Research of Charlotte /ID# 237048
  • Raleigh Neurology Associates /ID# 237138
  • CTI Clinical Research Center /ID# 237278
  • University of Cincinnati /ID# 234403
  • Aventiv Research Columbus /ID# 236837
  • OK Clinical Research /ID# 236675
  • IPS Research Company /ID# 237674
  • Summit Headlands LLC /ID# 236077
  • Abington Neurological Associates - Abington /ID# 236257
  • Lehigh Center for Clinical Research /ID# 236703
  • Suburban Research Associates - Media /ID# 236698
  • Thomas Jefferson University Jefferson Headache Center /ID# 235821
  • Frontier Clinical Research /ID# 237924
  • Clinical Trials of SC /ID# 237338
  • WR-ClinSearch /ID# 238287
  • CNS Healthcare - Memphis /ID# 236396
  • FutureSearch Trials of Neurology /ID# 236428
  • Tekton Research, Inc. /ID# 237306
  • DiscoveResearch, Inc /ID# 236273
  • FutureSearch Trials of Dallas, LP /ID# 236276
  • Centex Studies, Inc. - Houston /ID# 237458
  • ClinPoint Trials /ID# 236618
  • Advanced Research Institute /ID# 237749
  • University of Utah /ID# 237602
  • Charlottesville Medical Research /ID# 237792
  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253
  • Tidewater Integr Med Research /ID# 236867
  • Sentara Neurology Specialists - Virginia Beach /ID# 234350
  • Northwest Clinical Research Center /ID# 237585
  • Seattle Clinical Research Center /ID# 236912
  • Puget Sound Neurology /ID# 236322

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Sequence A

Treatment Sequence B

Arm Description

Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event

Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event

Outcomes

Primary Outcome Measures

Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose
The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.

Secondary Outcome Measures

Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose
The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome
Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose
The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.

Full Information

First Posted
July 27, 2020
Last Updated
May 30, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04492020
Brief Title
Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
Acronym
UBR Prodrome
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
518 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Sequence A
Arm Type
Experimental
Arm Description
Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event
Arm Title
Treatment Sequence B
Arm Type
Experimental
Arm Description
Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event
Intervention Type
Drug
Intervention Name(s)
Ubrogepant 100 mg
Intervention Description
For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
Primary Outcome Measure Information:
Title
Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose
Description
The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
Time Frame
24 hours after taking double-blind study intervention during the prodrome
Secondary Outcome Measure Information:
Title
Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose
Description
The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache
Time Frame
48 hours after taking double-blind study intervention during the prodrome
Title
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
Description
The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome
Time Frame
24 hours after taking double-blind study intervention during the prodrome
Title
Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose
Description
The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
Time Frame
24 hours after taking double-blind study intervention during the prodrome

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 ICHD-3 (International Classification of Headache Disorders 3rd edition) Migraine onset before age 50 years By history, the participant's migraines typically last 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 in each of the 3 months prior to the Screening Visit Exclusion Criteria: Difficulty distinguishing migraine headache from tension-type or other headaches Participants who overuse medication for migraine defined as use of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3 A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or more headache days per month on average in the 6 months prior to Visit 1 in the investigator's judgment. A headache day is defined as a day in which there was any occurrence of a headache of a minimum duration of 2 hours or a headache of any duration for which acute medication was taken Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3 Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Visit 1 History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that, per investigator judgment, may affect the absorption or metabolism of the study intervention; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Achieve Clinical Research, LLC /ID# 237098
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Barrow Neuro Institute /ID# 236775
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Arkansas Clinical Research /ID# 238032
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
California Headache and Balance Center /ID# 236247
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Sun Valley Research Center /ID# 236561
City
Imperial
State/Province
California
ZIP/Postal Code
92251-9401
Country
United States
Facility Name
Wr-Pri Llc /Id# 236007
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Excell Research, Inc /ID# 237721
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
George J. Rederich M.D. Inc. /ID# 235769
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Diablo Clinical Research /ID# 237570
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Colorado Springs Neurological Associates (CSNA) /ID# 236556
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Advanced Neurosciences Research, LLC /ID# 237426
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
CNS Healthcare - Jacksonville /ID# 238245
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256-6039
Country
United States
Facility Name
Health Awareness, Inc - Jupiter /ID# 236226
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458-7021
Country
United States
Facility Name
Suncoast Clinical Research /ID# 236934
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Sensible Healthcare /ID# 238090
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc /ID# 236608
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801-2986
Country
United States
Facility Name
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709-3113
Country
United States
Facility Name
University of South Florida /ID# 234387
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
ForCare Clinical Research /ID# 237092
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Premiere Research Institute - Palm Beach /ID# 238193
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3209
Country
United States
Facility Name
NeuroTrials Research Inc. /ID# 237365
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
iResearch Atlanta, LLC /ID# 237390
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Meridian Clinical Research (Neurology) - Savannah /ID# 234371
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406-2758
Country
United States
Facility Name
Clinical Research Atlanta - Headlands LLC /ID# 234438
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281-9054
Country
United States
Facility Name
Northwest Clinical Trials /ID# 234968
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Deaconess Clinic Downtown /ID# 236959
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713-1227
Country
United States
Facility Name
PMG Research of McFarland /ID# 238271
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010-5733
Country
United States
Facility Name
Collective Medical Research /ID# 236402
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Kansas Institute of Research /ID# 236738
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211-1363
Country
United States
Facility Name
Boston Clinical Trials /ID# 236559
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131-2515
Country
United States
Facility Name
Michigan Headache & Neurological Institute (MHNI) /ID# 236565
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104-5131
Country
United States
Facility Name
Minneapolis Clinic of Neurology - Golden Valley /ID# 238162
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422-4215
Country
United States
Facility Name
Clinical Research Institute, Inc /ID# 238301
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402-2606
Country
United States
Facility Name
StudyMetrix Research /ID# 236457
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Clinvest Research LLC /ID# 237908
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Princeton Center for Clinical Research /ID# 235734
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Bio Behavioral Health, Inc /ID# 238212
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755-6434
Country
United States
Facility Name
Dent Neurosciences Research Center, Inc. /ID# 237039
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Central New York Clinical Research /ID# 235694
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Rochester Clinical Research /ID# 236842
City
New York
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Upstate Clinical Research Associates /ID# 238220
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221-6046
Country
United States
Facility Name
PMG Research of Charlotte /ID# 237048
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Raleigh Neurology Associates /ID# 237138
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
CTI Clinical Research Center /ID# 237278
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
University of Cincinnati /ID# 234403
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Aventiv Research Columbus /ID# 236837
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
OK Clinical Research /ID# 236675
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034-3257
Country
United States
Facility Name
IPS Research Company /ID# 237674
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Summit Headlands LLC /ID# 236077
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Abington Neurological Associates - Abington /ID# 236257
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Lehigh Center for Clinical Research /ID# 236703
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104-5034
Country
United States
Facility Name
Suburban Research Associates - Media /ID# 236698
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063-1760
Country
United States
Facility Name
Thomas Jefferson University Jefferson Headache Center /ID# 235821
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Frontier Clinical Research /ID# 237924
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Clinical Trials of SC /ID# 237338
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
WR-ClinSearch /ID# 238287
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421-1605
Country
United States
Facility Name
CNS Healthcare - Memphis /ID# 236396
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Trials of Neurology /ID# 236428
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Tekton Research, Inc. /ID# 237306
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
DiscoveResearch, Inc /ID# 236273
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP /ID# 236276
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Centex Studies, Inc. - Houston /ID# 237458
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
ClinPoint Trials /ID# 236618
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165-1430
Country
United States
Facility Name
Advanced Research Institute /ID# 237749
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
University of Utah /ID# 237602
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
Charlottesville Medical Research /ID# 237792
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Tidewater Integr Med Research /ID# 236867
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23451
Country
United States
Facility Name
Sentara Neurology Specialists - Virginia Beach /ID# 234350
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456-0019
Country
United States
Facility Name
Northwest Clinical Research Center /ID# 237585
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Seattle Clinical Research Center /ID# 236912
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Puget Sound Neurology /ID# 236322
City
Tacoma
State/Province
Washington
ZIP/Postal Code
25328
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.allerganclinicaltrials.com/,http://www.investigatordatabank.org/
Description
Additional information on study locations near you may be found at www.AllerganClinicalTrials.com.

Learn more about this trial

Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

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