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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04740827
Registration number
NCT04740827
Ethics application status
Date submitted
2/02/2021
Date registered
5/02/2021
Date last updated
21/09/2023
Titles & IDs
Public title
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
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Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)
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Secondary ID [1]
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2019-003448-58
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Secondary ID [2]
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3101-304-002
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Universal Trial Number (UTN)
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Trial acronym
ELEVATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Episodic Migraine
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atogepant 60 mg
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.
Active Comparator: Atogepant 60 mg - Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
Treatment: Drugs: Atogepant 60 mg
Atogepant tablets.
Treatment: Drugs: Placebo
Atogepant matching placebo tablets.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
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Assessment method [1]
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Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis.
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Timepoint [1]
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Baseline to Week 12
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Primary outcome [2]
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Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population
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Assessment method [2]
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Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
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Timepoint [2]
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Baseline to Week 12
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Secondary outcome [1]
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Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population
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Assessment method [1]
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Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28.
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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [2]
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Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population
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Assessment method [2]
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Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28.
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Timepoint [2]
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Baseline to Week 12
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Secondary outcome [3]
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Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population
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Assessment method [3]
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Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
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Timepoint [3]
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Baseline to Week 12
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Secondary outcome [4]
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Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population
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Assessment method [4]
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Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
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Timepoint [4]
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Baseline to Week 12
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Secondary outcome [5]
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Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population
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Assessment method [5]
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An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.
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Timepoint [5]
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Baseline to Week 12
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Secondary outcome [6]
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Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population
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Assessment method [6]
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An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.
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Timepoint [6]
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Baseline to Week 12
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Secondary outcome [7]
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Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population
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Assessment method [7]
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The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis.
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Timepoint [7]
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Baseline to Week 12
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Secondary outcome [8]
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Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population
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Assessment method [8]
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The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis.
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Timepoint [8]
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Baseline to Week 12
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Secondary outcome [9]
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Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) Across the 12-Week Treatment Period in mITT Population
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Assessment method [9]
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The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).
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Timepoint [9]
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Baseline to Week 12
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Secondary outcome [10]
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Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population
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Assessment method [10]
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The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).
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Timepoint [10]
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Baseline to Week 12
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Secondary outcome [11]
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Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population
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Assessment method [11]
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HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses.
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Timepoint [11]
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Baseline to Week 12
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Secondary outcome [12]
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Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [12]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. TEAEs were defined as any AE with the onset that was after the first dose of study intervention.
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Timepoint [12]
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From first dose of study drug until 30 days after last dose of study drug (up to Week 12)
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Eligibility
Key inclusion criteria
- At least a 1-year history of migraine with or without aura consistent with a diagnosis
according to the ICHD-3, 2018.
- 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 in the
investigator's judgment
- Female participants willing to minimize the risk of inducing pregnancy for the
duration of the clinical study and follow-up period. Male participants willing to
minimize the risk of inducing pregnancy for the duration of the clinical study and
follow-up period.
- 4 to 14 migraine days in the 28-day baseline period per eDiary
- Failed oral migraine prophylaxis medications from 2 to 4 medication classes
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Any clinically significant hematologic, endocrine, pulmonary, hepatic,
gastrointestinal, or neurologic disease
- Participant has any other concurrent pain condition that, in the opinion of the
investigator, may significantly impact the current headache disorder
- In the opinion of the investigator, confounding psychiatric conditions, dementia,
epilepsy, or significant neurological disorders other than migraine
- Has = 15 headache days per month on average across the 3 months prior to Visit 1 in
the investigator's judgment
- Has = 15 headache days in the 28-day baseline period per eDiary
- Clinically significant cardiovascular or cerebrovascular disease
- Has a history of migraine accompanied by diplopia or decreased level of consciousness
or retinal migraine as defined by ICHD-3, 2018
- Has a current diagnosis of chronic migraine, new persistent daily headache, medication
overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful
cranial neuropathy as defined by ICHD-3, 2018
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/08/2022
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Sample size
Target
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Accrual to date
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Final
315
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health /ID# 226341 - Melbourne
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Recruitment hospital [2]
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The Royal Melbourne Hospital /ID# 226402 - Parkville
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Russian Federation
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State/province [75]
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Moscow
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Country [76]
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Spain
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State/province [76]
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Cantabria
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Country [77]
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Spain
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State/province [77]
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Castellon
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Country [78]
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Spain
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State/province [78]
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Barcelona
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Country [79]
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Spain
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State/province [79]
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Madrid
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Country [80]
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Spain
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State/province [80]
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Valencia
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Country [81]
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Spain
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State/province [81]
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Zaragoza
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Country [82]
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Sweden
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State/province [82]
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Stockholms Lan
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Country [83]
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United Kingdom
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State/province [83]
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Glasgow
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Country [84]
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United Kingdom
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State/province [84]
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Guildford
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Country [85]
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United Kingdom
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State/province [85]
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Inverness
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Country [86]
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United Kingdom
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State/province [86]
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Leeds
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Country [87]
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United Kingdom
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State/province [87]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Ethics approval
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Summary
Brief summary
This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared
with placebo in participants with episodic migraine and who have previously failed 2 to 4
classes of oral prophylactic treatments.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04740827
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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ALLERGAN INC.
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Allergan
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04740827
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