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Calcitonin Gene-Related Peptide (CGRP) Antagonist
Atogepant 60 mg for Migraine (ELEVATE Trial)
Phase 3
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug until 30 days after last dose of study drug (up to week 12)
Awards & highlights
ELEVATE Trial Summary
This study is evaluating whether a medication may help reduce the number of migraines in individuals who have not responded to other medications.
Eligible Conditions
- Migraine
ELEVATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study drug until 30 days after last dose of study drug (up to week 12)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug until 30 days after last dose of study drug (up to week 12)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
Secondary outcome measures
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population
Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population
+9 moreELEVATE Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Atogepant 60 mgActive Control1 Intervention
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.
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Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
276,254 Total Patients Enrolled
10 Trials studying Migraine
5,869 Patients Enrolled for Migraine
Dr. Joel TrugmanStudy DirectorAllergan
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,944 Total Patients Enrolled
5 Trials studying Migraine
4,687 Patients Enrolled for Migraine
Frequently Asked Questions
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