Episodic Migraine
Conditions
Brief summary
This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.
Interventions
DRUGStandard of Care (SOC) Migraine Preventive Medication
Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.
DRUGAtogepant
Atogepant tablets taken orally, once daily for 52 weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures. * Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment. * Participants must be using a medically acceptable and effective method of birth control during the course of the entire study, * At least a 1-year history of migraine with or without aura consistent with a diagnosis * Age of the participant at the time of migraine onset \< 50 years * History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1
Exclusion criteria
* Difficulty distinguishing migraine headaches from tension-type or other headaches * Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine * Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy * ≥ 15 headache days per month on average across the 3 months prior to Visit 1 * Usage of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well * Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test * Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease * Hypertension as defined by sitting systolic blood pressure (BP) \> 160 millimeter of mercury (mm Hg) or sitting diastolic BP \> 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once. * At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence * History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) | From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any 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. A TEAE is an AE that occurs or worsens after receiving investigational study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up | Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported. |
| Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator | Up to Week 52 | A standard 12-lead ECG was performed. The investigator determined if the result was potentially clinically significant. Only categories with at least one participant are reported. |
| Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) | Vital sign measurements included sitting and standing blood pressure (BP), sitting and standing pulse rate, respiratory rate, temperature, and body weight. The investigator determined if the results were clinically significant. Only categories with at least one participant are reported. |
| Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | Up to Week 52 | The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). Only the most severe suicidal ideation and the most severe suicidal behavior counted during the treatment period for at least 1 participant are reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oral SOC Migraine Preventive Medication Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant. | 196 |
| Atogepant 60 mg Atogepant 60 mg tablet taken orally, once daily for 52 weeks. | 543 |
| Total | 739 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 31 |
| Overall Study | Lack of Efficacy | 2 | 5 |
| Overall Study | Lost to Follow-up | 16 | 23 |
| Overall Study | Non-compliance with Study Drug | 1 | 3 |
| Overall Study | Pregnancy | 2 | 4 |
| Overall Study | Protocol Deviation | 7 | 31 |
| Overall Study | Reason not Specified | 0 | 1 |
| Overall Study | Withdrawal by Subject | 29 | 75 |
Baseline characteristics
| Characteristic | Atogepant 60 mg | Total | Oral SOC Migraine Preventive Medication |
|---|---|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 12.03 | 42.2 years STANDARD_DEVIATION 12.05 | 41.1 years STANDARD_DEVIATION 12.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 83 Participants | 112 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 460 Participants | 626 Participants | 166 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 17 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 100 Participants | 138 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 15 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 416 Participants | 561 Participants | 145 Participants |
| Sex: Female, Male Female | 479 Participants | 651 Participants | 172 Participants |
| Sex: Female, Male Male | 64 Participants | 88 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 198 | 2 / 546 |
| other Total, other adverse events | 91 / 196 | 197 / 543 |
| serious Total, serious adverse events | 7 / 196 | 24 / 543 |
Outcome results
Primary
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any 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. A TEAE is an AE that occurs or worsens after receiving investigational study drug.
Time frame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Population: Safety Population included all participants who received ≥1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral SOC Migraine Preventive Medication | Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) | 78.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) | 67.0 percentage of participants |
Secondary
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). Only the most severe suicidal ideation and the most severe suicidal behavior counted during the treatment period for at least 1 participant are reported.
Time frame: Up to Week 52
Population: Safety Population included all participants who received ≥1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral SOC Migraine Preventive Medication | Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | SI: Non-Specific Active Suicidal Thoughts | 1 Participants |
| Oral SOC Migraine Preventive Medication | Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | SI: Active SI With Specific Plan and Intent | 0 Participants |
| Oral SOC Migraine Preventive Medication | Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | SI: Active SI with Some Intent to Act, Without Specific Plan | 0 Participants |
| Oral SOC Migraine Preventive Medication | Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | Suicidal Behavior (SB): Actual Attempt | 0 Participants |
| Oral SOC Migraine Preventive Medication | Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | Suicidal Ideation (SI): Wish to be Dead | 4 Participants |
| Atogepant 60 mg | Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | Suicidal Behavior (SB): Actual Attempt | 2 Participants |
| Atogepant 60 mg | Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | Suicidal Ideation (SI): Wish to be Dead | 0 Participants |
| Atogepant 60 mg | Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | SI: Non-Specific Active Suicidal Thoughts | 2 Participants |
| Atogepant 60 mg | Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | SI: Active SI with Some Intent to Act, Without Specific Plan | 1 Participants |
| Atogepant 60 mg | Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior | SI: Active SI With Specific Plan and Intent | 2 Participants |
Secondary
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator
A standard 12-lead ECG was performed. The investigator determined if the result was potentially clinically significant. Only categories with at least one participant are reported.
Time frame: Up to Week 52
Population: Safety Population included all participants who received ≥1 dose of study intervention. Number analyzed is the number of participants with non-missing non-PCS baseline value and ≥1 post-baseline parameter assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator | PR Interval, Single Beat millisecond (msec): ≥250 | 0.0 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator | QTcB Interval, Single Beat (msec): Increase >60 from Baseline (BL) | 0.6 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator | QTcF Interval, Single Beat (msec): Increase >60 from BL | 0.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator | PR Interval, Single Beat millisecond (msec): ≥250 | 0.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator | QTcB Interval, Single Beat (msec): Increase >60 from Baseline (BL) | 0.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator | QTcF Interval, Single Beat (msec): Increase >60 from BL | 0.0 percentage of participants |
Secondary
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator
Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported.
Time frame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Population: Safety Population included all participants who received ≥1 dose of study intervention. Number analyzed is the number of participants with non-missing non-PCS baseline value and ≥1 post-baseline parameter assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | White Blood Cell Count (10^9/L): >1.5 × ULN | 1.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Hematocrit (RATIO): <0.9 × lower limit of normal (LLN) | 1.6 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Hematocrit (RATIO): >1.1 × ULN | 0.0 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Hemoglobin (gram (g)/L): <0.9 × LLN | 3.3 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Lymphocytes Absolute Cell Count (10^9/L): <0.7 × LLN | 0.5 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Lymphocytes Absolute Cell Count (10^9/L): >1.3 × ULN | 0.5 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Neutrophils Absolute Cell Count (10^9/L): <0.7 × LLN | 2.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Neutrophils Absolute Cell Count (10^9/L): >1.3 × ULN | 4.8 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Eosinophils Absolute Cell Count (10^9/liter (L)): >2.0 × upper limit of normal (ULN) | 0.0 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Alanine Aminotransferase (serum glutamic-pyruvic transaminase (SGPT)) (Unit (U)/L): ≥3.0 × ULN | 1.6 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Aspartate Aminotransferase (serum glutamic-oxaloacetic transaminase (SGOT)) (U/L): ≥3.0 × ULN | 2.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Potassium (mmol/L): <0.9 × LLN | 1.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Uric Acid (Urate) (umol/L): >1.2 × ULN | 1.6 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Urine Glucose At Least 1+ | 4.3 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Monocytes Absolute Cell Count (10^9/L): <0.5 × LLN | 1.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Platelet Count (Thrombocytes) (10^9/L): >1.5 × ULN | 0.5 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Red Blood Cell Count (10^12/L): <0.9 × LLN | 3.2 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | White Blood Cell Count (10^9/L): <0.9 × LLN | 3.2 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Bicarbonate (HCO3) (millimole (mmol)/L): <0.9 × LLN | 1.6 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Bilirubin, Total (micromole (umol)/L): ≥1.5 × ULN | 0.0 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Blood Urea Nitrogen (mmol/L): >1.5 × ULN | 0.5 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Creatine Kinase (U/L): >2.0 × ULN | 14.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Creatinine (umol/L): >1.5 × ULN | 1.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Glomerular Filtration Rate(GFR) Estimated Calculation:<60 milliliter(mL)/minute(min)/1.73 meter(m)^2 | 15.2 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Glucose, Non-fasting (mmol/L): <0.8 × LLN | 5.3 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Glucose, Non-fasting (mmol/L): >2.0 × ULN | 2.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Lactate Dehydrogenase (U/L): >3.0 × ULN | 0.0 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Phosphorus (mmol/L): <0.9 × LLN | 2.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Phosphorus (mmol/L): >1.1 × ULN | 0.0 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Potassium (mmol/L): >1.1 × ULN | 4.3 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Protein, Total (g/L): <0.9 × LLN | 3.2 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Urine Protein: At Least 1+ | 26.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Red Blood Cell Count (10^12/L): <0.9 × LLN | 2.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Eosinophils Absolute Cell Count (10^9/liter (L)): >2.0 × upper limit of normal (ULN) | 0.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Urine Glucose At Least 1+ | 3.0 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Hematocrit (RATIO): <0.9 × lower limit of normal (LLN) | 1.7 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Aspartate Aminotransferase (serum glutamic-oxaloacetic transaminase (SGOT)) (U/L): ≥3.0 × ULN | 1.5 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Hematocrit (RATIO): >1.1 × ULN | 0.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Glucose, Non-fasting (mmol/L): >2.0 × ULN | 0.8 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Hemoglobin (gram (g)/L): <0.9 × LLN | 3.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Bicarbonate (HCO3) (millimole (mmol)/L): <0.9 × LLN | 0.8 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Lymphocytes Absolute Cell Count (10^9/L): <0.7 × LLN | 0.8 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Potassium (mmol/L): >1.1 × ULN | 5.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Monocytes Absolute Cell Count (10^9/L): <0.5 × LLN | 0.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Bilirubin, Total (micromole (umol)/L): ≥1.5 × ULN | 0.8 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Neutrophils Absolute Cell Count (10^9/L): <0.7 × LLN | 2.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Lactate Dehydrogenase (U/L): >3.0 × ULN | 0.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | White Blood Cell Count (10^9/L): <0.9 × LLN | 4.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Blood Urea Nitrogen (mmol/L): >1.5 × ULN | 0.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | White Blood Cell Count (10^9/L): >1.5 × ULN | 0.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Urine Protein: At Least 1+ | 27.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Alanine Aminotransferase (serum glutamic-pyruvic transaminase (SGPT)) (Unit (U)/L): ≥3.0 × ULN | 1.9 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Creatine Kinase (U/L): >2.0 × ULN | 9.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Phosphorus (mmol/L): <0.9 × LLN | 2.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Potassium (mmol/L): <0.9 × LLN | 0.8 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Creatinine (umol/L): >1.5 × ULN | 0.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Uric Acid (Urate) (umol/L): >1.2 × ULN | 1.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Protein, Total (g/L): <0.9 × LLN | 1.5 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Lymphocytes Absolute Cell Count (10^9/L): >1.3 × ULN | 0.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Glomerular Filtration Rate(GFR) Estimated Calculation:<60 milliliter(mL)/minute(min)/1.73 meter(m)^2 | 15.9 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Neutrophils Absolute Cell Count (10^9/L): >1.3 × ULN | 7.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Phosphorus (mmol/L): >1.1 × ULN | 0.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Platelet Count (Thrombocytes) (10^9/L): >1.5 × ULN | 0.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator | Glucose, Non-fasting (mmol/L): <0.8 × LLN | 4.2 percentage of participants |
Secondary
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Vital sign measurements included sitting and standing blood pressure (BP), sitting and standing pulse rate, respiratory rate, temperature, and body weight. The investigator determined if the results were clinically significant. Only categories with at least one participant are reported.
Time frame: From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up)
Population: Safety Population included all participants who received ≥1 dose of study intervention. Number analyzed is the number of participants with non-missing non-PCS baseline value and ≥1 post-baseline parameter assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | SBP Standing (mmHg): ≤90 and Decrease of ≥20 from BL | 5.8 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | DBP Standing (mmHg): ≤50 and Decrease of ≥15 from BL | 1.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | PR Standing (beats/min): ≤50 and Decrease of ≥15 from BL | 0.0 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | DBP Standing (mmHg): ≥105 and Increase of ≥15 from BL | 5.8 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Standing - Sitting SBP (mmHg): ≤-20 | 13.8 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Standing - Sitting DBP (mmHg): ≤-15 | 10.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | SBP Sitting (mmHg): ≥180 and Increase of ≥20 from BL | 0.0 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Pulse Rate (PR) Sitting (beats/min): ≤50 and Decrease of ≥15 from BL | 1.6 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Diastolic Blood Pressure (DBP) Sitting (mmHg): ≤50 and Decrease of ≥15 from BL | 3.2 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | PR Standing (beats/min): ≥120 and Increase of ≥15 from BL | 2.6 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Systolic Blood Pressure (SBP) Sitting (millimeter of mercury(mmHg)):≤90 and Decrease of ≥20 from BL | 3.7 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Standing - Sitting PR (beats/min): ≥25 | 6.3 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Weight (kg): Decrease of ≥7% from BL | 14.7 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | DBP Sitting (mmHg): ≥105 and Increase of ≥15 from BL | 1.1 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Weight (kg): Increase of ≥7% from BL | 12.6 percentage of participants |
| Oral SOC Migraine Preventive Medication | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | SBP Standing (mmHg): ≥180 and Increase of ≥20 from BL | 0.0 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Weight (kg): Increase of ≥7% from BL | 7.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | SBP Standing (mmHg): ≥180 and Increase of ≥20 from BL | 0.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | PR Standing (beats/min): ≤50 and Decrease of ≥15 from BL | 0.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Standing - Sitting PR (beats/min): ≥25 | 10.0 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Systolic Blood Pressure (SBP) Sitting (millimeter of mercury(mmHg)):≤90 and Decrease of ≥20 from BL | 2.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | SBP Sitting (mmHg): ≥180 and Increase of ≥20 from BL | 0.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | SBP Standing (mmHg): ≤90 and Decrease of ≥20 from BL | 3.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Standing - Sitting SBP (mmHg): ≤-20 | 11.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Diastolic Blood Pressure (DBP) Sitting (mmHg): ≤50 and Decrease of ≥15 from BL | 0.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | DBP Sitting (mmHg): ≥105 and Increase of ≥15 from BL | 2.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | DBP Standing (mmHg): ≤50 and Decrease of ≥15 from BL | 0.9 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | DBP Standing (mmHg): ≥105 and Increase of ≥15 from BL | 4.0 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Standing - Sitting DBP (mmHg): ≤-15 | 8.7 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Pulse Rate (PR) Sitting (beats/min): ≤50 and Decrease of ≥15 from BL | 1.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | PR Standing (beats/min): ≥120 and Increase of ≥15 from BL | 1.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Weight (kg): Decrease of ≥7% from BL | 24.1 percentage of participants |