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Anti-migraine agent

Ubrogepant for Migraine

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
Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
At least a 1-year history of migraine with or without aura.
Timeline
Screening 3 days
Treatment 3 days
Follow Up 3 days
Awards & highlights
Pivotal Trial

Summary

This trial aims to study the safety and effectiveness of a new drug called ubrogepant in treating menstrual migraines. Menstrual migraines are headaches that occur before, during, or after

Who is the study for?
This trial is for adult females with a history of migraine, specifically menstrual migraine. Participants should have regular menstrual cycles and experience migraines during their period in at least two out of three cycles. They must be able to record daily diary data and have had less than 15 headache days per month.
What is being tested?
The study tests Ubrogepant's safety and effectiveness against placebo in preventing menstrual migraines. Around 450 women will take oral ubrogepant or placebo starting three days before their estimated menses for seven days, over three menstrual periods in the initial phase.
What are the potential side effects?
Possible side effects include typical drug reactions such as nausea, drowsiness, dry mouth, or more serious ones like allergic reactions. The exact side effects will be monitored through medical assessments and questionnaires.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had migraine attacks during my period in at least 2 of the last 3 cycles.
Select...
I have had migraines for at least a year.
Select...
I have fewer than 15 headache days a month.

Timeline

Screening ~ 3 days
Treatment ~ 3 days
Follow Up ~3 days
This trial's timeline: 3 days for screening, 3 days for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Period (PMP)
Number of Participants With Adverse Events (AEs)
Secondary study objectives
Change From Baseline in Acute Medication Use Days During the Perimenstrual Period (PMP)
Change From Baseline in Number of Headache Days Occurring During Perimenstrual Period (PMP)
Change From Baseline in Number of Migraine Days With Moderate or Severe Headache During Perimenstrual Period (PMP)
+4 more

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Open-Label Extension Period: UbrogepantExperimental Treatment1 Intervention
Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.
Group II: Double-Blind Period: UbrogepantExperimental Treatment1 Intervention
Participants will receive ubrogepant during the double-blind period.
Group III: Double-Blind Period: Placebo for UbrogepantExperimental Treatment1 Intervention
Participants will receive placebo during the double-blind period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ubrogepant
2016
Completed Phase 4
~4990

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,029 Previous Clinical Trials
521,080 Total Patients Enrolled
13 Trials studying Migraine
11,813 Patients Enrolled for Migraine
ABBVIE INC.Study DirectorAbbVie
450 Previous Clinical Trials
161,566 Total Patients Enrolled
13 Trials studying Migraine
11,813 Patients Enrolled for Migraine
~300 spots leftby Sep 2027
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