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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

TEMPLE 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.Check my eligibility

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.See study design

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.

TEMPLE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 4 to month 6 (double-blind treatment period)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)

Secondary outcome measures

Percentage of Participants Achieving >= 50% Improvement (Reduction) in Mean Monthly Migraine Days Based on mITT Population.

TEMPLE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

964 Previous Clinical Trials

502,505 Total Patients Enrolled

9 Trials studying Migraine

7,139 Patients Enrolled for Migraine

ABBVIE INC.Study DirectorAbbVie

402 Previous Clinical Trials

147,079 Total Patients Enrolled

9 Trials studying Migraine

7,139 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA authorized Atogepant for medicinal use?

"There is a degree of clinical evidence in favour of Atogepant's safety, leading us to rate it 3 out of 3. This medication has gone through both efficacy and safety testing as part of its Phase 3 trial."

Answered by AI

Are individuals of all ages being invited to join this experiment?

"Patients aged between 18 and 80 are eligible for this clinical trial. Meanwhile, there are 35 studies dedicated to minors under the age of 18, as well as 117 trials specifically designed for individuals over 65 years old."

Answered by AI

Could I be considered a potential participant in this trial?

"This medical trial is currently accepting applications from individuals suffering with migraine who are between eighteen and eighty years old. Around five hundred twenty patients will be enrolled in the study."

Answered by AI

Has recruitment for this clinical trial been opened up to the public yet?

"According to clinicaltrials.gov, no new participants are being sought for this medical trial at present- the study was first posted on June 30th 2023 and last edited February 20th 2023. However, there is still an abundance of other studies actively searching for candidates right now - 176 in total."

Answered by AI

In what geographic regions is this research endeavor being conducted?

"Currently, 85 patients are being signed up to the trial at distinct medical locations such as Medizinische Universitaet Wien /ID# 247119 in Vienna, Konventhospital Barm. Brueder /ID# 247217 in Linz and UZ Gent /ID# 246957 in Gent along with many other recruiting sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

2023. "Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05748483.

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