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Calcium Channel Blocker

Atogepant vs Topiramate for Migraine (TEMPLE Trial)

Phase 3
Recruiting
Research Sponsored by AbbVie
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 month 4 to month 6 (double-blind treatment period)
Awards & highlights
Pivotal Trial

Summary

This trial will study whether a medicine (atogepant) is safe and effective for preventing migraine symptoms compared to another medicine (topiramate). 520 participants will be enrolled worldwide. Both medicines are taken by mouth.

Who is the study for?
Adults with a history of migraines for at least 12 months, experiencing 4 or more migraine days per month and needing preventive treatment. Participants should not have used Atogepant or Topiramate before and must be free from significant health issues in major body systems like the heart, brain, blood, hormones, lungs, kidneys, liver, stomach or nerves.
What is being tested?
The trial is testing the tolerability and safety of Atogepant compared to Topiramate for preventing migraines. Initially participants are randomly assigned to receive either Atogepant with placebo for Topiramate or vice versa for 24 weeks; afterwards all eligible participants will take Atogepant for an additional 52 weeks.
What are the potential side effects?
Possible side effects include reactions typical of migraine medications which may involve nausea, fatigue, dizziness and other digestive disturbances. Specific side effects related to each drug will be monitored through medical assessments and questionnaires.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 4 to month 6 (double-blind treatment period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 4 to month 6 (double-blind treatment period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)
Secondary study objectives
Percentage of Participants Achieving >= 50% Improvement (Reduction) in Mean Monthly Migraine Days Based on mITT Population.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AtogepantExperimental Treatment2 Interventions
Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Group II: TopiramateActive Control3 Interventions
Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atogepant
2018
Completed Phase 4
~3490

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,022 Previous Clinical Trials
519,659 Total Patients Enrolled
12 Trials studying Migraine
11,551 Patients Enrolled for Migraine
ABBVIE INC.Study DirectorAbbVie
443 Previous Clinical Trials
160,145 Total Patients Enrolled
12 Trials studying Migraine
11,551 Patients Enrolled for Migraine

Media Library

Atogepant (Calcium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05748483 — Phase 3
Migraine Research Study Groups: Atogepant, Topiramate
Migraine Clinical Trial 2023: Atogepant Highlights & Side Effects. Trial Name: NCT05748483 — Phase 3
Atogepant (Calcium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05748483 — Phase 3
~309 spots leftby Jun 2026
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