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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ubrogepant 50 mg | Experimental | 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. |
|
| Ubrogepant 100 mg | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubrogepant | Drug | 50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Predose) to 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. | Baseline (Predose) to 2 hours after initial dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adele Thorpe | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Advantage, Inc./Desert Clinical Research, LLC. | Mesa | Arizona | 85213 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39982105 | Derived | Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610. | |
| 36125279 | Derived |
| Label | URL |
|---|---|
| More Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 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. |
| FG001 | Ubrogepant 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2017 | Dec 13, 2018 |
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| Placebo-matching Ubrogepant | Drug | Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack. |
|
| Baseline (Predose) to 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. | 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. | 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. | 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. | 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. | 2 hours after initial dose |
| Xenoscience, Inc. |
| Phoenix |
| Arizona |
| 85004 |
| United States |
| Clinical Research Advantage, Inc./Orange Grove Family Practice | Tucson | Arizona | 85741 | United States |
| Principals Research Group, Inc. | Hot Springs | Arkansas | 71901 | United States |
| KLR Business Group, Inc. dba Arkansas Clinical Research | Little Rock | Arkansas | 72205 | United States |
| The Research Center of Southern California, LLC | Carlsbad | California | 92011 | United States |
| Med Center | Carmichael | California | 95608 | United States |
| T. Joseph Raoof MD, Inc./Encino Research Center | Encino | California | 91436 | United States |
| Neurology Center of North Orange County | Fullerton | California | 92835 | United States |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | United States |
| Prime Care Clinical Research | Laguna Hills | California | 92656 | United States |
| Collaborative Neuroscience Network, LLC. | Long Beach | California | 90806 | United States |
| Synergy San Diego | National City | California | 91950 | United States |
| Newport Beach Clinical Research Associates, Inc. | Newport Beach | California | 92663 | United States |
| North County Clinical Research | Oceanside | California | 92054 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| CA Medical Clinic for Headache | Santa Monica | California | 90404 | United States |
| Southern California Research LLC | Simi Valley | California | 93065 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Alpine Clinical Research Center, Inc. | Boulder | Colorado | 80301 | United States |
| Colorado Springs Neurological Associates | Colorado Springs | Colorado | 80907 | United States |
| Delta Waves, Inc | Colorado Springs | Colorado | 80918 | United States |
| Denver Neurological Research | Denver | Colorado | 80210 | United States |
| Associated Neurologists, P.C. | Danbury | Connecticut | 06810 | United States |
| Associated Neurolgists of Southern Connecticut, PC | Fairfield | Connecticut | 06824 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| CPI MD Clinical | Hallandale | Florida | 33009 | United States |
| Infinity Clinical Research, LLC | Hollywood | Florida | 33024 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Palm Beach Neurological Center/Advanced Research Consultants, Inc. | Palm Beach Gardens | Florida | 33410 | United States |
| Meridien Research | Spring Hill | Florida | 34609 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Meridien Research | Tampa | Florida | 33634 | United States |
| Neurology Research Institute | West Palm Beach | Florida | 33407 | United States |
| Midtown Neurology | Atlanta | Georgia | 30312 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Deaconess Clinic, Medical Office Building 1 Research Institute | Newburgh | Indiana | 47630 | United States |
| Rowe Neurology Institute | Lenexa | Kansas | 66214 | United States |
| Kansas Institute of Research | Overland Park | Kansas | 66211 | United States |
| College Park Family Care Center Physicians Group - Neurology Research Department | Overland Park | Kansas | 66212 | United States |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | United States |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Northeast Medical Research Associates, Inc | South Dartmouth | Massachusetts | 02747 | United States |
| MedVadis Research Corporation | Watertown | Massachusetts | 02472 | United States |
| Michigan Head-Pain & Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Beyer Research | Kalamazoo | Michigan | 49009 | United States |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | United States |
| Olive Branch Family Medical Center | Olive Branch | Mississippi | 38654 | United States |
| Clinvest Research, LLC | Springfield | Missouri | 65810 | United States |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | United States |
| Clinical Research Advantage, Inc./Diagnostic Center of Medicine - Durango | Las Vegas | Nevada | 89117 | United States |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | 87109 | United States |
| Regional Clinical Research, Inc. | Endwell | New York | 13760 | United States |
| Central New York Clinical Research | Manlius | New York | 13104 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Neurology Associates, P.A. | Hickory | North Carolina | 28602 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| PMG Research of Winston-Salem, LLC. | Winston-Salem | North Carolina | 27103 | United States |
| Neuro-Behavioral Clinical Research, Inc. | Canton | Ohio | 44718 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Aventiv Research, Inc | Columbus | Ohio | 43213 | United States |
| Ohio Clinical Research, LLC | Lyndhurst | Ohio | 44124 | United States |
| MPH IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| NPC Research | Oklahoma City | Oklahoma | 73109 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Oregon Center For Clinical Investigations Inc. (OCCI, Inc.) | Portland | Oregon | 97214 | United States |
| Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| BTC of Lincoln | Lincoln | Rhode Island | 02865 | United States |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| Tekton Research, Inc. | Austin | Texas | 78745 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| Red Star Research, LLC | Lake Jackson | Texas | 77566 | United States |
| Clinical Trials Texas, Inc | San Antonio | Texas | 78229 | United States |
| Road Runner Research, Ltd. | San Antonio | Texas | 78249 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic Draper | Draper | Utah | 84020 | United States |
| Granger Medical Clinic-Riverton | Riverton | Utah | 84065 | United States |
| Optimum Clinical Research, Inc. | Salt Lake City | Utah | 84102 | United States |
| Highland Clinical Research | Salt Lake City | Utah | 84124 | United States |
| Tidewater Integrated Medical Research | Virginia Beach | Virginia | 23454 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| The Polyclinic Madison Center | Seattle | Washington | 98104 | United States |
| 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. |
| 35468729 | Derived | 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. |
| 34874514 | Derived | 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. |
| 33874756 | Derived | 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. |
| 33608814 | Derived | 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. |
| 33241721 | Derived | 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. |
| 31800988 | Derived | 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. |
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. |
| FG002 | Ubrogepant 100 mg | 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. |
| Safety Population: Received Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Safety Follow-up Period |
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|
Intent-to-Treat (ITT) population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 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. |
| BG001 | Ubrogepant 50 mg | 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. |
| BG002 | Ubrogepant 100 mg | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intent-to-Treat (mITT) population included all randomized participants who received at least 1 dose of study drug, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, last observation carried forward (LOCF). | Posted | Number | percentage of participants | Baseline (Predose) to 2 hours after initial dose |
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| Primary | 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. | mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF. | Posted | Number | percentage of participants | Baseline (Predose) to 2 hours after initial dose |
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| Secondary | 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. | mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF. | Posted | Number | percentage of participants | Baseline (Predose) to 2 hours after initial dose |
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| Secondary | 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. | mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases. | Posted | Number | percentage of participants | 2 to 24 hours after initial dose |
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| Secondary | 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. | mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases. | Posted | Number | percentage of participants | 2 to 24 hours after initial dose |
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| Secondary | 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. | mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF. | Posted | Number | percentage of participants | 2 hours after initial dose |
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| Secondary | 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. | mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF. | Posted | Number | percentage of participants | 2 hours after initial dose |
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| Secondary | 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. | mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF. | Posted | Number | percentage of participants | 2 hours after initial dose |
|
From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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. | 0 | 485 | 0 | 485 | 0 | 485 |
| EG001 | Ubrogepant 50 mg | 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. | 0 | 466 | 3 | 466 | 0 | 466 |
| EG002 | Ubrogepant 100 mg | 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. | 0 | 485 | 2 | 485 | 0 | 485 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA, version 20.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA, version 20.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA, version 20.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA, version 20.1 | Systematic Assessment |
|
Not provided
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2018 | Dec 13, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000615620 | ubrogepant |
Not provided
Not provided
Not provided
| Protocol Violation |
|
| Other Miscellaneous Reasons |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian/Other Pacific Islander |
|
| Multiple |
|
| Not Hispanic or Latino |
|
| Regression, Logistic |
Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model. |
| 0.0003 |
P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses. |
| Odds Ratio (OR) |
| 2.04 |
| 2-Sided |
| 95 |
| 1.41 |
| 2.95 |
| Superiority |
| OG002 | Ubrogepant 100 mg | 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. |
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| OG002 | Ubrogepant 100 mg | 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. |
|
|
|
| Ubrogepant 50 mg |
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. |
| OG002 | Ubrogepant 100 mg | 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. |
|
|
|
| Ubrogepant 50 mg |
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. |
| OG002 | Ubrogepant 100 mg | 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. |
|
|
|
| OG002 |
| Ubrogepant 100 mg |
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. |
|
|
|
| OG002 |
| Ubrogepant 100 mg |
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. |
|
|
|
| Ubrogepant 100 mg |
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. |
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