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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02828020
Recruitment Status : Completed
First Posted : July 11, 2016
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine, With or Without Aura
Interventions Drug: Ubrogepant
Drug: Placebo-matching Ubrogepant
Enrollment 1672
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Hide Arm/Group Description 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment. 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment. 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Period Title: Treatment Period
Started 559 556 557
Safety Population: Received Study Drug 485 466 485
Completed 479 457 479
Not Completed 80 99 78
Reason Not Completed
Adverse Event             3             1             1
Withdrawal of Consent             10             14             9
Lost to Follow-up             21             24             18
Lack of Qualifying Event             44             53             43
Pregnancy             0             2             0
Protocol Violation             2             4             7
Other Miscellaneous Reasons             0             1             0
Period Title: Safety Follow-up Period
Started 480 [1] 458 [1] 480 [1]
Completed 460 440 461
Not Completed 20 18 19
Reason Not Completed
Withdrawal of Consent             10             8             7
Lost to Follow-up             9             8             11
Protocol Violation             0             2             1
Other Miscellaneous Reasons             1             0             0
[1]
1 participant who did not complete the Treatment Period, was counted in the Safety Follow-up Period.
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg Total
Hide Arm/Group Description 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment. 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment. 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment. Total of all reporting groups
Overall Number of Baseline Participants 559 556 557 1672
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 559 participants 556 participants 557 participants 1672 participants
41.1  (11.9) 40.2  (12.0) 40.7  (12.4) 40.7  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 559 participants 556 participants 557 participants 1672 participants
Female
491
  87.8%
493
  88.7%
479
  86.0%
1463
  87.5%
Male
68
  12.2%
63
  11.3%
78
  14.0%
209
  12.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 559 participants 556 participants 557 participants 1672 participants
White
471
  84.3%
459
  82.6%
447
  80.3%
1377
  82.4%
Black or African American
65
  11.6%
77
  13.8%
88
  15.8%
230
  13.8%
Asian
10
   1.8%
9
   1.6%
8
   1.4%
27
   1.6%
American Indian or Alaska Native
3
   0.5%
3
   0.5%
5
   0.9%
11
   0.7%
Native Hawaiian/Other Pacific Islander
3
   0.5%
1
   0.2%
5
   0.9%
9
   0.5%
Multiple
7
   1.3%
7
   1.3%
4
   0.7%
18
   1.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 559 participants 556 participants 557 participants 1672 participants
Hispanic or Latino
60
  10.7%
67
  12.1%
66
  11.8%
193
  11.5%
Not Hispanic or Latino
499
  89.3%
489
  87.9%
491
  88.2%
1479
  88.5%
1.Primary Outcome
Title Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Hide Description Pain freedom was defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
Time Frame Baseline (Predose) to 2 hours after initial dose
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Hide Arm/Group Description:
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Overall Number of Participants Analyzed 456 422 448
Measure Type: Number
Unit of Measure: percentage of participants
11.8 19.2 21.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.83
Confidence Interval (2-Sided) 95%
1.25 to 2.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.04
Confidence Interval (2-Sided) 95%
1.41 to 2.95
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
Hide Description The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms.
Time Frame Baseline (Predose) to 2 hours after initial dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Hide Arm/Group Description:
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Overall Number of Participants Analyzed 454 420 448
Measure Type: Number
Unit of Measure: percentage of participants
27.8 38.6 37.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
1.27 to 2.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
1.22 to 2.17
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose
Hide Description Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.
Time Frame Baseline (Predose) to 2 hours after initial dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Hide Arm/Group Description:
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Overall Number of Participants Analyzed 456 422 448
Measure Type: Number
Unit of Measure: percentage of participants
49.1 60.7 61.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.69
Confidence Interval (2-Sided) 95%
1.28 to 2.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.69
Confidence Interval (2-Sided) 95%
1.28 to 2.21
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose
Hide Description Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain relief from 2 to 24 hours after initial dose.
Time Frame 2 to 24 hours after initial dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Hide Arm/Group Description:
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Overall Number of Participants Analyzed 447 413 434
Measure Type: Number
Unit of Measure: percentage of participants
20.8 36.3 38.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.25
Confidence Interval (2-Sided) 95%
1.65 to 3.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.39
Confidence Interval (2-Sided) 95%
1.77 to 3.24
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose
Hide Description Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain freedom from 2 to 24 hours after initial dose.
Time Frame 2 to 24 hours after initial dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Hide Arm/Group Description:
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Overall Number of Participants Analyzed 452 418 441
Measure Type: Number
Unit of Measure: percentage of participants
8.6 12.7 15.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0577
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.57
Confidence Interval (2-Sided) 95%
1.01 to 2.44
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.95
Confidence Interval (2-Sided) 95%
1.28 to 2.97
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose
Time Frame 2 hours after initial dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Hide Arm/Group Description:
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Overall Number of Participants Analyzed 456 423 448
Measure Type: Number
Unit of Measure: percentage of participants
31.4 40.7 45.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0577
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
1.22 to 2.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
1.36 to 2.42
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose
Time Frame 2 hours after initial dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Hide Arm/Group Description:
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Overall Number of Participants Analyzed 456 423 448
Measure Type: Number
Unit of Measure: percentage of participants
47.1 57.9 54.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0577
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
1.16 to 2.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0577
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
1.10 to 1.95
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose
Hide Description Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.
Time Frame 2 hours after initial dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Hide Arm/Group Description:
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Overall Number of Participants Analyzed 456 423 448
Measure Type: Number
Unit of Measure: percentage of participants
62.3 70.2 69.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0962
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.96 to 1.79
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0962
Comments P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.
Method Regression, Logistic
Comments Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
1.00 to 1.83
Estimation Comments [Not Specified]
Time Frame From first dose through 30 days after the last dose of study drug (approximately 30 days)
Adverse Event Reporting Description 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
 
Arm/Group Title Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Hide Arm/Group Description 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment. 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment. 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
All-Cause Mortality
Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/485 (0.00%)   0/466 (0.00%)   0/485 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/485 (0.00%)   3/466 (0.64%)   2/485 (0.41%) 
Cardiac disorders       
Pericardial effusion  1  0/485 (0.00%)  1/466 (0.21%)  0/485 (0.00%) 
Infections and infestations       
Appendicitis  1  0/485 (0.00%)  1/466 (0.21%)  1/485 (0.21%) 
Nervous system disorders       
Seizure  1  0/485 (0.00%)  0/466 (0.00%)  1/485 (0.21%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/485 (0.00%)  1/466 (0.21%)  0/485 (0.00%) 
1
Term from vocabulary, MedDRA, version 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Ubrogepant 50 mg Ubrogepant 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/485 (0.00%)   0/466 (0.00%)   0/485 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02828020     History of Changes
Other Study ID Numbers: UBR-MD-01
First Submitted: July 7, 2016
First Posted: July 11, 2016
Results First Submitted: December 13, 2018
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019