Migraine, With or Without Aura
Conditions
Brief summary
This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.
Detailed description
Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.
Interventions
DRUGUbrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.
DRUGUsual Care
Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
-Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).
Exclusion criteria
* Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities * Requirement for a medication during the study that is on the list of prohibited medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 1 Treatment Emergent Adverse Event | 56 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Laboratory Values | 56 Weeks | Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria. |
| Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | 56 Weeks | ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria. |
| Number of Participants With Clinically Significant Vital Sign Measurements | 56 Weeks | Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria. |
| Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales | 56 Weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 417 |
| 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. | 417 |
| 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. | 420 |
| Total | 1,254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Safety Follow-up Period | Lost to Follow-up | 3 | 5 | 5 |
| Safety Follow-up Period | Other Miscellaneous Reasons | 0 | 2 | 0 |
| Safety Follow-up Period | Protocol Violation | 0 | 0 | 1 |
| Safety Follow-up Period | Withdrawal of Consent | 4 | 10 | 8 |
| Treatment Period | Adverse Event | 4 | 9 | 11 |
| Treatment Period | Lack of Efficacy | 0 | 17 | 12 |
| Treatment Period | Lack of Qualifying Event | 0 | 3 | 1 |
| Treatment Period | Lost to Follow-up | 26 | 30 | 26 |
| Treatment Period | Non-Compliance with Study Drug | 0 | 3 | 2 |
| Treatment Period | Other Miscellaneous Reasons | 0 | 2 | 1 |
| Treatment Period | Pregnancy | 4 | 6 | 3 |
| Treatment Period | Protocol Violation | 2 | 5 | 8 |
| Treatment Period | Withdrawal of Consent | 52 | 51 | 41 |
Baseline characteristics
| Characteristic | Usual Care | Ubrogepant 50 mg | Ubrogepant 100 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 41.7 Years STANDARD_DEVIATION 11.7 | 42.2 Years STANDARD_DEVIATION 12.2 | 41.2 Years STANDARD_DEVIATION 11.2 | 41.7 Years STANDARD_DEVIATION 11.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 2 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Black or African American | 50 Participants | 52 Participants | 61 Participants | 163 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 62 Participants | 64 Participants | 59 Participants | 185 Participants |
| Race/Ethnicity, Customized Multiple | 4 Participants | 2 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 355 Participants | 353 Participants | 361 Participants | 1069 Participants |
| Race/Ethnicity, Customized White | 356 Participants | 358 Participants | 345 Participants | 1059 Participants |
| Sex: Female, Male Female | 367 Participants | 384 Participants | 375 Participants | 1126 Participants |
| Sex: Female, Male Male | 50 Participants | 33 Participants | 45 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 417 | 0 / 404 | 0 / 409 |
| other Total, other adverse events | 132 / 417 | 125 / 404 | 138 / 409 |
| serious Total, serious adverse events | 17 / 417 | 9 / 404 | 12 / 409 |
Outcome results
Primary
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event
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.
Time frame: 56 Weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Percentage of Participants With at Least 1 Treatment Emergent Adverse Event | 65 Percentage of Participants |
| Ubrogepant 50 mg | Percentage of Participants With at Least 1 Treatment Emergent Adverse Event | 66.3 Percentage of Participants |
| Ubrogepant 100 mg | Percentage of Participants With at Least 1 Treatment Emergent Adverse Event | 72.6 Percentage of Participants |
Secondary
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
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
Time frame: 56 Weeks
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | 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 |
| Usual Care | 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 |
| Ubrogepant 50 mg | Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales | Suicidal Ideation | 3 Participants |
| Ubrogepant 50 mg | 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 |
| Ubrogepant 100 mg | Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales | Suicidal Ideation | 2 Participants |
| Ubrogepant 100 mg | 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 |
Secondary
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Time frame: 56 Weeks
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | PR interval (msec) PR >= 250 | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Fridericia (msec) QTcF > 500 | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Bazett (msec) QTcB > 500 | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QRS interval (msec) QRS >= 150 | 1 Participants |
| Usual Care | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Fridericia (msec) Increase > 60 (msec) | 1 Participants |
| Usual Care | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Bazett (msec) Increase > 60 (msec) | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QRS interval (msec) QRS >= 150 | 1 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Bazett (msec) Increase > 60 (msec) | 1 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Fridericia (msec) QTcF > 500 | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | PR interval (msec) PR >= 250 | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Bazett (msec) QTcB > 500 | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Fridericia (msec) Increase > 60 (msec) | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Bazett (msec) QTcB > 500 | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Fridericia (msec) QTcF > 500 | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Bazett (msec) Increase > 60 (msec) | 5 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QRS interval (msec) QRS >= 150 | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | PR interval (msec) PR >= 250 | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings | QTc Fridericia (msec) Increase > 60 (msec) | 0 Participants |
Secondary
Number of Participants With Clinically Significant Laboratory Values
Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Time frame: 56 Weeks
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Calcium (mmol/L) >1.1×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Monocytes Absolute Cell Count (10**9/L) >2×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Bicarbonate (HCO3) (mmol/L) >1.1×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Calcium (mmol/L) <0.9×LLN | 2 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Neutrophils Absolute Cell Count (10**9/L) <0.7×LLN | 6 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Protein, Total (g/L) >1.1×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Bilirubin, Total (umol/L) >1.5×ULN | 3 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Neutrophils Absolute Cell Count (10**9/L) >1.3×ULN | 22 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Blood Urea Nitrogen (mmol/L) >1.5×ULN | 6 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Aspartate Aminotransferase (SGOT) (U/L) >3×ULN | 2 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Platelet Count (Thrombocytes) (10**9/L) <0.5×LLN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | pH (pH) >1.1×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Alkaline Phosphatase (U/L) >3×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Platelet Count (Thrombocytes) (10**9/L) >1.5×ULN | 2 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Albumin (g/L) >1.2×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Red Blood Cell Count (10**12/L) <0.9×LLN | 1 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Protein, Total (g/L) <0.9×LLN | 3 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Albumin (g/L) <0.8×LLN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Red Blood Cell Count (10**12/L) >1.1×ULN | 2 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Potassium (mmol/L) >1.1×ULN | 28 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Alanine Aminotransferase (SGPT) (U/L) >3×ULN | 4 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | White Blood Cell Count (10**9/L) <0.9×LLN | 17 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Potassium (mmol/L) <0.9×LLN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Specific Gravity >1.1×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Phosphorus (mmol/L) >1.1×ULN | 21 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Creatinine (umol/L) >1.5×ULN | 1 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | pH (pH) <0.9×LLN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Phosphorus (mmol/L) <0.9×LLN | 45 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Lactate Dehydrogenase (U/L) >3×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Uric Acid (Urate) (umol/L) >1.2×ULN | 26 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Glucose, Non-fasting (mmol/L) >2×ULN | 1 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Monocytes Absolute Cell Count (10**9/L) <0.5×LLN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Glucose, Non-fasting (mmol/L) <0.8×LLN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Protein (g/L) Positive | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Basophils Absolute Cell Count (10**9/L) >2×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Eosinophils Absolute Cell Count (10**9/L) >2×ULN | 1 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | White Blood Cell Count (10**9/L) >1.5×ULN | 5 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Creatine Kinase (U/L) >2×ULN | 56 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Hematocrit (RATIO) <0.9×LLN | 3 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Hemoglobin (g/L) >1.1×ULN | 2 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Cholesterol, Total (mmol/L) >1.6×ULN | 4 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Hematocrit (RATIO) >1.1×ULN | 2 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Glucose Positive | 21 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Chloride (mmol/L) >1.1×UL | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Hemoglobin (g/L) <0.9×LLN | 7 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Triglycerides (mmol/L) >2×ULN | 30 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Sodium (mmol/L) >1.1×ULN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Lymphocytes Absolute Cell Count (10**9/L) <0.7×LLN | 11 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Bicarbonate (HCO3) (mmol/L) <0.9×LLN | 25 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Chloride (mmol/L) <0.9×LLN | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Lymphocytes Absolute Cell Count (10**9/L) >1.3×ULN | 8 Participants |
| Usual Care | Number of Participants With Clinically Significant Laboratory Values | Sodium (mmol/L) <0.9×LLN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Sodium (mmol/L) <0.9×LLN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Lymphocytes Absolute Cell Count (10**9/L) >1.3×ULN | 6 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Platelet Count (Thrombocytes) (10**9/L) >1.5×ULN | 2 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | White Blood Cell Count (10**9/L) >1.5×ULN | 2 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Blood Urea Nitrogen (mmol/L) >1.5×ULN | 3 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Creatine Kinase (U/L) >2×ULN | 43 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Creatinine (umol/L) >1.5×ULN | 1 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | pH (pH) <0.9×LLN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Protein (g/L) Positive | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Eosinophils Absolute Cell Count (10**9/L) >2×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Hematocrit (RATIO) <0.9×LLN | 2 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Hematocrit (RATIO) >1.1×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Hemoglobin (g/L) <0.9×LLN | 3 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Hemoglobin (g/L) >1.1×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Lymphocytes Absolute Cell Count (10**9/L) <0.7×LLN | 5 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Monocytes Absolute Cell Count (10**9/L) <0.5×LLN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Monocytes Absolute Cell Count (10**9/L) >2×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Neutrophils Absolute Cell Count (10**9/L) <0.7×LLN | 5 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Neutrophils Absolute Cell Count (10**9/L) >1.3×ULN | 14 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Platelet Count (Thrombocytes) (10**9/L) <0.5×LLN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Red Blood Cell Count (10**12/L) <0.9×LLN | 5 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Red Blood Cell Count (10**12/L) >1.1×ULN | 2 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | White Blood Cell Count (10**9/L) <0.9×LLN | 9 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Alanine Aminotransferase (SGPT) (U/L) >3×ULN | 4 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Albumin (g/L) <0.8×LLN | 1 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Albumin (g/L) >1.2×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Alkaline Phosphatase (U/L) >3×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Aspartate Aminotransferase (SGOT) (U/L) >3×ULN | 2 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Bicarbonate (HCO3) (mmol/L) <0.9×LLN | 22 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Bicarbonate (HCO3) (mmol/L) >1.1×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Bilirubin, Total (umol/L) >1.5×ULN | 4 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Calcium (mmol/L) <0.9×LLN | 1 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Calcium (mmol/L) >1.1×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Chloride (mmol/L) <0.9×LLN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Chloride (mmol/L) >1.1×UL | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Cholesterol, Total (mmol/L) >1.6×ULN | 1 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Glucose, Non-fasting (mmol/L) <0.8×LLN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Glucose, Non-fasting (mmol/L) >2×ULN | 1 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Lactate Dehydrogenase (U/L) >3×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Phosphorus (mmol/L) <0.9×LLN | 38 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Phosphorus (mmol/L) >1.1×ULN | 15 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Potassium (mmol/L) <0.9×LLN | 1 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Potassium (mmol/L) >1.1×ULN | 32 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Protein, Total (g/L) <0.9×LLN | 2 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Protein, Total (g/L) >1.1×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Basophils Absolute Cell Count (10**9/L) >2×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Sodium (mmol/L) >1.1×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Triglycerides (mmol/L) >2×ULN | 20 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Uric Acid (Urate) (umol/L) >1.2×ULN | 27 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Glucose Positive | 17 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | pH (pH) >1.1×ULN | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Laboratory Values | Specific Gravity >1.1×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Aspartate Aminotransferase (SGOT) (U/L) >3×ULN | 9 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Chloride (mmol/L) >1.1×UL | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Hematocrit (RATIO) <0.9×LLN | 6 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | pH (pH) >1.1×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Eosinophils Absolute Cell Count (10**9/L) >2×ULN | 1 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | pH (pH) <0.9×LLN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Sodium (mmol/L) >1.1×ULN | 2 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Uric Acid (Urate) (umol/L) >1.2×ULN | 22 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Alkaline Phosphatase (U/L) >3×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Glucose, Non-fasting (mmol/L) >2×ULN | 1 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Glucose, Non-fasting (mmol/L) <0.8×LLN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Hemoglobin (g/L) <0.9×LLN | 6 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Lactate Dehydrogenase (U/L) >3×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Creatinine (umol/L) >1.5×ULN | 1 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Protein (g/L) Positive | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Phosphorus (mmol/L) <0.9×LLN | 42 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Creatine Kinase (U/L) >2×ULN | 57 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | White Blood Cell Count (10**9/L) >1.5×ULN | 4 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Phosphorus (mmol/L) >1.1×ULN | 21 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Cholesterol, Total (mmol/L) >1.6×ULN | 2 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Basophils Absolute Cell Count (10**9/L) >2×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Potassium (mmol/L) <0.9×LLN | 3 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Triglycerides (mmol/L) >2×ULN | 17 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | White Blood Cell Count (10**9/L) <0.9×LLN | 17 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Red Blood Cell Count (10**12/L) >1.1×ULN | 2 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Glucose Positive | 23 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Alanine Aminotransferase (SGPT) (U/L) >3×ULN | 8 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Red Blood Cell Count (10**12/L) <0.9×LLN | 3 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Potassium (mmol/L) >1.1×ULN | 33 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Albumin (g/L) <0.8×LLN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Platelet Count (Thrombocytes) (10**9/L) >1.5×ULN | 1 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Blood Urea Nitrogen (mmol/L) >1.5×ULN | 1 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Albumin (g/L) >1.2×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Platelet Count (Thrombocytes) (10**9/L) <0.5×LLN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Lymphocytes Absolute Cell Count (10**9/L) >1.3×ULN | 8 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Neutrophils Absolute Cell Count (10**9/L) >1.3×ULN | 17 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Protein, Total (g/L) <0.9×LLN | 4 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Bilirubin, Total (umol/L) >1.5×ULN | 2 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Hemoglobin (g/L) >1.1×ULN | 1 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Bicarbonate (HCO3) (mmol/L) >1.1×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Neutrophils Absolute Cell Count (10**9/L) <0.7×LLN | 6 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Protein, Total (g/L) >1.1×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Monocytes Absolute Cell Count (10**9/L) >2×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Bicarbonate (HCO3) (mmol/L) <0.9×LLN | 37 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Calcium (mmol/L) <0.9×LLN | 3 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Monocytes Absolute Cell Count (10**9/L) <0.5×LLN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Specific Gravity >1.1×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Calcium (mmol/L) >1.1×ULN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Lymphocytes Absolute Cell Count (10**9/L) <0.7×LLN | 5 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Sodium (mmol/L) <0.9×LLN | 0 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Chloride (mmol/L) <0.9×LLN | 1 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Laboratory Values | Hematocrit (RATIO) >1.1×ULN | 1 Participants |
Secondary
Number of Participants With Clinically Significant Vital Sign Measurements
Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Time frame: 56 Weeks
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | Standing - Sitting DBP (mmHg) <= -15 | 38 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Standing) >= 180 and Increase of >= 20 | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min) (Sitting) <= 50, Decrease of >= 15 | 4 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Standing) >= 105 and Increase of >= 15 | 12 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | Standing - Sitting SBP (mmHg) <= -20 | 58 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Standing) <= 50 and Decrease of >= 15 | 5 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Sitting) >= 105 and Increase of >= 15 | 6 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min)(Standing) >= 120, Increase of >= 15 | 14 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | Standing - Sitting Pulse Rate (beats/min) >= 25 | 42 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | Weight (kg) Decrease of >= 7% | 58 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Sitting) <= 90 and Decrease of >= 20 | 11 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min) (Standing) <= 50, Decrease of >= 15 | 2 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Sitting) >= 180 and Increase of >= 20 | 0 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Sitting) <= 50 and Decrease of >= 15 | 6 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min) (Sitting) >= 120, Increase of >= 15 | 1 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Standing) <= 90 and Decrease of >= 20 | 12 Participants |
| Usual Care | Number of Participants With Clinically Significant Vital Sign Measurements | Weight (kg) Increase of >= 7% | 73 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | Standing - Sitting Pulse Rate (beats/min) >= 25 | 37 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Sitting) <= 90 and Decrease of >= 20 | 20 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | Standing - Sitting SBP (mmHg) <= -20 | 40 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Sitting) <= 50 and Decrease of >= 15 | 5 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Sitting) >= 180 and Increase of >= 20 | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Standing) <= 90 and Decrease of >= 20 | 11 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Standing) >= 180 and Increase of >= 20 | 0 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Sitting) >= 105 and Increase of >= 15 | 3 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Standing) <= 50 and Decrease of >= 15 | 4 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Standing) >= 105 and Increase of >= 15 | 14 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | Standing - Sitting DBP (mmHg) <= -15 | 42 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min) (Sitting) >= 120, Increase of >= 15 | 2 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min) (Standing) <= 50, Decrease of >= 15 | 3 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min)(Standing) >= 120, Increase of >= 15 | 9 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min) (Sitting) <= 50, Decrease of >= 15 | 5 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | Weight (kg) Decrease of >= 7% | 48 Participants |
| Ubrogepant 50 mg | Number of Participants With Clinically Significant Vital Sign Measurements | Weight (kg) Increase of >= 7% | 69 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | Standing - Sitting DBP (mmHg) <= -15 | 36 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Sitting) >= 180 and Increase of >= 20 | 1 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | Standing - Sitting Pulse Rate (beats/min) >= 25 | 35 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min) (Sitting) >= 120, Increase of >= 15 | 1 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Sitting) <= 90 and Decrease of >= 20 | 12 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | Weight (kg) Increase of >= 7% | 61 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min) (Standing) <= 50, Decrease of >= 15 | 3 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min) (Sitting) <= 50, Decrease of >= 15 | 7 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Sitting) >= 105 and Increase of >= 15 | 6 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Sitting) <= 50 and Decrease of >= 15 | 4 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | Weight (kg) Decrease of >= 7% | 53 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Standing) <= 50 and Decrease of >= 15 | 4 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Standing) >= 180 and Increase of >= 20 | 1 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | PR (beats/min)(Standing) >= 120, Increase of >= 15 | 13 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | DBP (mmHg) (Standing) >= 105 and Increase of >= 15 | 11 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | SBP (mmHg) (Standing) <= 90 and Decrease of >= 20 | 11 Participants |
| Ubrogepant 100 mg | Number of Participants With Clinically Significant Vital Sign Measurements | Standing - Sitting SBP (mmHg) <= -20 | 49 Participants |