Trial Outcomes & Findings for An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine (NCT NCT02873221)
NCT ID: NCT02873221
Last Updated: 2019-08-28
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1254 participants
Primary outcome timeframe
56 Weeks
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Usual Care
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
|
Ubrogepant 50 mg
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Ubrogepant 100 mg
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
|---|---|---|---|
|
Treatment Period
STARTED
|
417
|
417
|
420
|
|
Treatment Period
Safety Population: Received Study Drug
|
417
|
404
|
409
|
|
Treatment Period
COMPLETED
|
329
|
291
|
315
|
|
Treatment Period
NOT COMPLETED
|
88
|
126
|
105
|
|
Safety Follow-up Period
STARTED
|
350
|
356
|
364
|
|
Safety Follow-up Period
COMPLETED
|
343
|
339
|
350
|
|
Safety Follow-up Period
NOT COMPLETED
|
7
|
17
|
14
|
Reasons for withdrawal
| Measure |
Usual Care
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
|
Ubrogepant 50 mg
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Ubrogepant 100 mg
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
|---|---|---|---|
|
Treatment Period
Other Miscellaneous Reasons
|
0
|
2
|
1
|
|
Treatment Period
Non-Compliance with Study Drug
|
0
|
3
|
2
|
|
Treatment Period
Protocol Violation
|
2
|
5
|
8
|
|
Treatment Period
Pregnancy
|
4
|
6
|
3
|
|
Treatment Period
Lack of Qualifying Event
|
0
|
3
|
1
|
|
Treatment Period
Withdrawal of Consent
|
52
|
51
|
41
|
|
Treatment Period
Lack of Efficacy
|
0
|
17
|
12
|
|
Treatment Period
Adverse Event
|
4
|
9
|
11
|
|
Treatment Period
Lost to Follow-up
|
26
|
30
|
26
|
|
Safety Follow-up Period
Other Miscellaneous Reasons
|
0
|
2
|
0
|
|
Safety Follow-up Period
Protocol Violation
|
0
|
0
|
1
|
|
Safety Follow-up Period
Lost to Follow-up
|
3
|
5
|
5
|
|
Safety Follow-up Period
Withdrawal of Consent
|
4
|
10
|
8
|
Baseline Characteristics
An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
Baseline characteristics by cohort
| Measure |
Usual Care
n=417 Participants
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
|
Ubrogepant 50 mg
n=417 Participants
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Ubrogepant 100 mg
n=420 Participants
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Total
n=1254 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.7 Years
STANDARD_DEVIATION 11.7 • n=93 Participants
|
42.2 Years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
41.2 Years
STANDARD_DEVIATION 11.2 • n=27 Participants
|
41.7 Years
STANDARD_DEVIATION 11.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
367 Participants
n=93 Participants
|
384 Participants
n=4 Participants
|
375 Participants
n=27 Participants
|
1126 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
128 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
356 Participants
n=93 Participants
|
358 Participants
n=4 Participants
|
345 Participants
n=27 Participants
|
1059 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
50 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
163 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
62 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
185 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
355 Participants
n=93 Participants
|
353 Participants
n=4 Participants
|
361 Participants
n=27 Participants
|
1069 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 56 WeeksPopulation: The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Usual Care
n=417 Participants
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
|
Ubrogepant 50 mg
n=404 Participants
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Ubrogepant 100 mg
n=409 Participants
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event
|
65 Percentage of Participants
|
66.3 Percentage of Participants
|
72.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm
Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Outcome measures
| Measure |
Usual Care
n=417 Participants
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
|
Ubrogepant 50 mg
n=404 Participants
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Ubrogepant 100 mg
n=409 Participants
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Values
Lymphocytes Absolute Cell Count (10**9/L) <0.7×LLN
|
11 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Basophils Absolute Cell Count (10**9/L) >2×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Eosinophils Absolute Cell Count (10**9/L) >2×ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Hematocrit (RATIO) <0.9×LLN
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Hematocrit (RATIO) >1.1×ULN
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Hemoglobin (g/L) <0.9×LLN
|
7 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Hemoglobin (g/L) >1.1×ULN
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Lymphocytes Absolute Cell Count (10**9/L) >1.3×ULN
|
8 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Monocytes Absolute Cell Count (10**9/L) <0.5×LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Monocytes Absolute Cell Count (10**9/L) >2×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Neutrophils Absolute Cell Count (10**9/L) <0.7×LLN
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Neutrophils Absolute Cell Count (10**9/L) >1.3×ULN
|
22 Participants
|
14 Participants
|
17 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Platelet Count (Thrombocytes) (10**9/L) <0.5×LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Platelet Count (Thrombocytes) (10**9/L) >1.5×ULN
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Red Blood Cell Count (10**12/L) <0.9×LLN
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Red Blood Cell Count (10**12/L) >1.1×ULN
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
White Blood Cell Count (10**9/L) <0.9×LLN
|
17 Participants
|
9 Participants
|
17 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
White Blood Cell Count (10**9/L) >1.5×ULN
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Alanine Aminotransferase (SGPT) (U/L) >3×ULN
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Albumin (g/L) <0.8×LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Albumin (g/L) >1.2×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Alkaline Phosphatase (U/L) >3×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Aspartate Aminotransferase (SGOT) (U/L) >3×ULN
|
2 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Bicarbonate (HCO3) (mmol/L) <0.9×LLN
|
25 Participants
|
22 Participants
|
37 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Bicarbonate (HCO3) (mmol/L) >1.1×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Bilirubin, Total (umol/L) >1.5×ULN
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Blood Urea Nitrogen (mmol/L) >1.5×ULN
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Calcium (mmol/L) <0.9×LLN
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Calcium (mmol/L) >1.1×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Chloride (mmol/L) <0.9×LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Chloride (mmol/L) >1.1×UL
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Cholesterol, Total (mmol/L) >1.6×ULN
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Creatine Kinase (U/L) >2×ULN
|
56 Participants
|
43 Participants
|
57 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Creatinine (umol/L) >1.5×ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Glucose, Non-fasting (mmol/L) <0.8×LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Glucose, Non-fasting (mmol/L) >2×ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Lactate Dehydrogenase (U/L) >3×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Phosphorus (mmol/L) <0.9×LLN
|
45 Participants
|
38 Participants
|
42 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Phosphorus (mmol/L) >1.1×ULN
|
21 Participants
|
15 Participants
|
21 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Potassium (mmol/L) <0.9×LLN
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Potassium (mmol/L) >1.1×ULN
|
28 Participants
|
32 Participants
|
33 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Protein, Total (g/L) <0.9×LLN
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Protein, Total (g/L) >1.1×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Sodium (mmol/L) <0.9×LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Sodium (mmol/L) >1.1×ULN
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Triglycerides (mmol/L) >2×ULN
|
30 Participants
|
20 Participants
|
17 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Uric Acid (Urate) (umol/L) >1.2×ULN
|
26 Participants
|
27 Participants
|
22 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Glucose Positive
|
21 Participants
|
17 Participants
|
23 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
pH (pH) <0.9×LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
pH (pH) >1.1×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Protein (g/L) Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Values
Specific Gravity >1.1×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm
ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Outcome measures
| Measure |
Usual Care
n=417 Participants
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
|
Ubrogepant 50 mg
n=404 Participants
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Ubrogepant 100 mg
n=409 Participants
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
QTc Fridericia (msec) QTcF > 500
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
PR interval (msec) PR >= 250
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
QRS interval (msec) QRS >= 150
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
QTc Bazett (msec) QTcB > 500
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
QTc Bazett (msec) Increase > 60 (msec)
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
QTc Fridericia (msec) Increase > 60 (msec)
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm
Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Outcome measures
| Measure |
Usual Care
n=417 Participants
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
|
Ubrogepant 50 mg
n=404 Participants
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Ubrogepant 100 mg
n=409 Participants
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Measurements
PR (beats/min)(Standing) >= 120, Increase of >= 15
|
14 Participants
|
9 Participants
|
13 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
Standing - Sitting Pulse Rate (beats/min) >= 25
|
42 Participants
|
37 Participants
|
35 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
Weight (kg) Decrease of >= 7%
|
58 Participants
|
48 Participants
|
53 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
Weight (kg) Increase of >= 7%
|
73 Participants
|
69 Participants
|
61 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
PR (beats/min) (Standing) <= 50, Decrease of >= 15
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
PR (beats/min) (Sitting) >= 120, Increase of >= 15
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
SBP (mmHg) (Sitting) <= 90 and Decrease of >= 20
|
11 Participants
|
20 Participants
|
12 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
SBP (mmHg) (Sitting) >= 180 and Increase of >= 20
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
SBP (mmHg) (Standing) <= 90 and Decrease of >= 20
|
12 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
SBP (mmHg) (Standing) >= 180 and Increase of >= 20
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
Standing - Sitting SBP (mmHg) <= -20
|
58 Participants
|
40 Participants
|
49 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
DBP (mmHg) (Sitting) <= 50 and Decrease of >= 15
|
6 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
DBP (mmHg) (Sitting) >= 105 and Increase of >= 15
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
DBP (mmHg) (Standing) <= 50 and Decrease of >= 15
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
DBP (mmHg) (Standing) >= 105 and Increase of >= 15
|
12 Participants
|
14 Participants
|
11 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
Standing - Sitting DBP (mmHg) <= -15
|
38 Participants
|
42 Participants
|
36 Participants
|
|
Number of Participants With Clinically Significant Vital Sign Measurements
PR (beats/min) (Sitting) <= 50, Decrease of >= 15
|
4 Participants
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm
On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"
Outcome measures
| Measure |
Usual Care
n=417 Participants
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
|
Ubrogepant 50 mg
n=404 Participants
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Ubrogepant 100 mg
n=409 Participants
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
|---|---|---|---|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
Suicidal Ideation
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Usual Care
Serious events: 17 serious events
Other events: 132 other events
Deaths: 0 deaths
Ubrogepant 50 mg
Serious events: 9 serious events
Other events: 125 other events
Deaths: 0 deaths
Ubrogepant 100 mg
Serious events: 12 serious events
Other events: 138 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=417 participants at risk
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
|
Ubrogepant 50 mg
n=404 participants at risk
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Ubrogepant 100 mg
n=409 participants at risk
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Pneumonia
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Psychiatric disorders
Suicidal ideation
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.24%
1/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Appendicitis
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Gastrointestinal disorders
Constipation
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Immune system disorders
Device allergy
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Gastrointestinal disorders
Diverticulum
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Gastrointestinal disorders
Femoral hernia incarcerated
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
General disorders
Gait disturbance
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Gastroenteritis
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Nervous system disorders
Migraine
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Cardiac disorders
Myocardial infarction
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Post procedural infection
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Pyelonephritis
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Psychiatric disorders
Substance-induced mood disorder
|
0.00%
0/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.25%
1/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Nervous system disorders
Syncope
|
0.24%
1/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
0.00%
0/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
Other adverse events
| Measure |
Usual Care
n=417 participants at risk
Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
|
Ubrogepant 50 mg
n=404 participants at risk
Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
Ubrogepant 100 mg
n=409 participants at risk
Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.9%
33/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
8.2%
33/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
11.5%
47/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
48/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
11.6%
47/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
10.8%
44/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Sinusitis
|
6.0%
25/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
6.9%
28/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
6.4%
26/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Urinary tract infection
|
5.5%
23/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
5.4%
22/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
6.4%
26/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
|
Infections and infestations
Influenza
|
5.0%
21/417 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
4.2%
17/404 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
6.1%
25/409 • Adverse events were collected up to 56 weeks.
The Safety population is defined separately below for the ubrogepant arms and the usual-care arm. Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER