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

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ClinicalTrials.gov Identifier: NCT02867709
Recruitment Status : Completed
First Posted : August 16, 2016
Results First Posted : January 29, 2019
Last Update Posted : March 19, 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 1686
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Ubrogepant 25 mg Ubrogepant 50 mg
Hide Arm/Group Description 1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose. 1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose. 1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Period Title: Treatment Period
Started 563 561 562
Safety Population: Received Study Drug 499 478 488
Completed 493 474 487
Not Completed 70 87 75
Reason Not Completed
Adverse Event             1             1             2
Withdrawal of Consent             7             9             8
Lost to Follow-up             17             20             20
Lack of Qualifying Event             42             55             42
Protocol Violation             3             2             3
Period Title: Safety Follow-up Period
Started 493 474 487
Completed 482 459 473
Not Completed 11 15 14
Reason Not Completed
Withdrawal of Consent             1             8             6
Lost to Follow-up             10             5             7
Pregnancy             0             1             0
Protocol Violation             0             1             1
Arm/Group Title Placebo Ubrogepant 25 mg Ubrogepant 50 mg Total
Hide Arm/Group Description 1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose. 1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose. 1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose. Total of all reporting groups
Overall Number of Baseline Participants 563 561 562 1686
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 563 participants 561 participants 562 participants 1686 participants
41.5  (12.2) 41.6  (12.3) 41.0  (12.4) 41.4  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 563 participants 561 participants 562 participants 1686 participants
Female
494
  87.7%
501
  89.3%
497
  88.4%
1492
  88.5%
Male
69
  12.3%
60
  10.7%
65
  11.6%
194
  11.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 563 participants 561 participants 562 participants 1686 participants
White
449
  79.8%
467
  83.2%
456
  81.1%
1372
  81.4%
Black or African American
94
  16.7%
82
  14.6%
93
  16.5%
269
  16.0%
Asian
8
   1.4%
6
   1.1%
5
   0.9%
19
   1.1%
American Indian or Alaska Native
4
   0.7%
1
   0.2%
4
   0.7%
9
   0.5%
Native Hawaiian/Other Pacific Islander
1
   0.2%
1
   0.2%
1
   0.2%
3
   0.2%
Multiple
7
   1.2%
4
   0.7%
3
   0.5%
14
   0.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 563 participants 561 participants 562 participants 1686 participants
Hispanic or Latino
116
  20.6%
129
  23.0%
125
  22.2%
370
  21.9%
Not Hispanic or Latino
447
  79.4%
432
  77.0%
437
  77.8%
1316
  78.1%
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 pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with 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 25 mg Ubrogepant 50 mg
Hide Arm/Group Description:
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Overall Number of Participants Analyzed 456 435 464
Measure Type: Number
Unit of Measure: percentage of participants
14.3 20.7 21.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0285
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 1.56
Confidence Interval (2-Sided) 95%
1.09 to 2.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0129
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 1.62
Confidence Interval (2-Sided) 95%
1.14 to 2.29
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 assessed.
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 baseline migraine headache severity measurement, had ≥1 postdose migraine headache severity/migraine-associated symptom measurement at/before 2-hour timepoint, LOCF. Number analyzed is participants with data available for analysis.
Arm/Group Title Placebo Ubrogepant 25 mg Ubrogepant 50 mg
Hide Arm/Group Description:
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Overall Number of Participants Analyzed 456 434 463
Measure Type: Number
Unit of Measure: percentage of participants
27.4 34.1 38.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0711
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 1.37
Confidence Interval (2-Sided) 95%
1.02 to 1.83
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0129
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 1.65
Confidence Interval (2-Sided) 95%
1.25 to 2.20
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 25 mg Ubrogepant 50 mg
Hide Arm/Group Description:
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Overall Number of Participants Analyzed 456 435 464
Measure Type: Number
Unit of Measure: percentage of participants
48.2 60.5 62.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0711
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 1.65
Confidence Interval (2-Sided) 95%
1.25 to 2.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0129
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 1.77
Confidence Interval (2-Sided) 95%
1.35 to 2.32
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 assessment of 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 25 mg Ubrogepant 50 mg
Hide Arm/Group Description:
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Overall Number of Participants Analyzed 443 424 449
Measure Type: Number
Unit of Measure: percentage of participants
21.0 32.5 36.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0711
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 1.82
Confidence Interval (2-Sided) 95%
1.33 to 2.48
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0129
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 2.16
Confidence Interval (2-Sided) 95%
1.59 to 2.92
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 assessment of 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 25 mg Ubrogepant 50 mg
Hide Arm/Group Description:
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Overall Number of Participants Analyzed 451 432 457
Measure Type: Number
Unit of Measure: percentage of participants
8.2 12.7 14.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0711
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 1.62
Confidence Interval (2-Sided) 95%
1.04 to 2.53
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0129
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 1.85
Confidence Interval (2-Sided) 95%
1.20 to 2.83
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 25 mg Ubrogepant 50 mg
Hide Arm/Group Description:
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Overall Number of Participants Analyzed 456 435 464
Measure Type: Number
Unit of Measure: percentage of participants
35.5 39.3 43.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1833
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 1.28
Confidence Interval (2-Sided) 95%
0.96 to 1.72
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0167
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 1.52
Confidence Interval (2-Sided) 95%
1.14 to 2.02
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 25 mg Ubrogepant 50 mg
Hide Arm/Group Description:
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Overall Number of Participants Analyzed 456 435 464
Measure Type: Number
Unit of Measure: percentage of participants
46.3 53.6 54.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1066
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 1.38
Confidence Interval (2-Sided) 95%
1.04 to 1.83
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0440
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 1.39
Confidence Interval (2-Sided) 95%
1.05 to 1.84
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 25 mg Ubrogepant 50 mg
Hide Arm/Group Description:
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Overall Number of Participants Analyzed 456 435 464
Measure Type: Number
Unit of Measure: percentage of participants
70.0 70.6 71.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ubrogepant 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9522
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 1.10
Confidence Interval (2-Sided) 95%
0.81 to 1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.9522
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 1.12
Confidence Interval (2-Sided) 95%
0.83 to 1.51
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 25 mg Ubrogepant 50 mg
Hide Arm/Group Description 1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose. 1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose. 1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
All-Cause Mortality
Placebo Ubrogepant 25 mg Ubrogepant 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/499 (0.00%)   0/478 (0.00%)   0/488 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ubrogepant 25 mg Ubrogepant 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/499 (0.00%)   1/478 (0.21%)   0/488 (0.00%) 
Injury, poisoning and procedural complications       
Ligament sprain  1  0/499 (0.00%)  1/478 (0.21%)  0/488 (0.00%) 
Road traffic accident  1  0/499 (0.00%)  1/478 (0.21%)  0/488 (0.00%) 
Splenic rupture  1  0/499 (0.00%)  1/478 (0.21%)  0/488 (0.00%) 
Traumatic renal injury  1  0/499 (0.00%)  1/478 (0.21%)  0/488 (0.00%) 
Nervous system disorders       
Loss of consciousness  1  0/499 (0.00%)  1/478 (0.21%)  0/488 (0.00%) 
Syncope  1  0/499 (0.00%)  1/478 (0.21%)  0/488 (0.00%) 
Renal and urinary disorders       
Renal haematoma  1  0/499 (0.00%)  1/478 (0.21%)  0/488 (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 25 mg Ubrogepant 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/499 (0.00%)   0/478 (0.00%)   0/488 (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
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02867709     History of Changes
Other Study ID Numbers: UBR-MD-02
First Submitted: August 12, 2016
First Posted: August 16, 2016
Results First Submitted: January 9, 2019
Results First Posted: January 29, 2019
Last Update Posted: March 19, 2019