← Back to Search

Oral Ubrogepant vs. Oral Atogepant in Healthy Women

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 30

Awards & highlights

Study Summary

This trial will compare how ubrogepant and atogepant tablets move through the body in healthy lactating women. 24 participants will be enrolled in the US.

Who is the study for?

This trial is for healthy, lactating women who recently gave birth to a full-term infant and are between 1-6 months post-partum. They should have had an uncomplicated pregnancy and be willing to use alternative milk sources for their infants during the study. Women who've taken ubrogepant or atogepant in the last 30 days cannot participate.Check my eligibility

What is being tested?

The study is examining how two migraine medications, ubrogepant and atogepant, are processed by the bodies of healthy lactating women. Participants will receive one dose of either medication and will be monitored over a period of 30 days across three U.S. sites.See study design

What are the potential side effects?

While specific side effects in this context aren't detailed, common side effects from these drugs can include nausea, dry mouth, drowsiness, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 30 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

AUC From Time 0 to the Time Infinity (AUCinf) of Atogepant

AUCinf of Ubrogepant

AUCt of Ubrogepant

+18 more

Side effects data

From 2020 Phase 3 trial • 744 Patients • NCT03700320

10%

Upper respiratory tract infection

Constipation

Nausea

Urinary tract infection

Nasopharyngitis

Fatigue

Dizziness

Anxiety

Paraesthesia

Weight increased

100%

80%

60%

40%

20%

Study treatment Arm

Atogepant 60 mg

Oral SOC Migraine Preventive Medication

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AtogepantExperimental Treatment1 Intervention

Participants will receive single dose of atogepant on Day 1.

Group II: UbrogepantActive Control1 Intervention

Participants will receive single dose of ubrogepant on Day 1.

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

954 Previous Clinical Trials

501,020 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,854 Total Patients Enrolled

Media Library

Healthy Subjects Research Study Groups: Atogepant, Ubrogepant

Frequently Asked Questions

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

Are any individuals aged 80 or above being admitted into this research project?

"This research project is seeking individuals aged 18 and up to 45 years old."

Answered by AI

Is recruitment still open for this research project?

"Indeed, the information on clinicaltrials.gov suggests that this trial is enrolling patients at present. It was first posted to the website on June 26th 2023 and most recently updated a few days later on June 30th of the same year. A modest number (24) of participants need to be recruited from 1 site."

Answered by AI

Has Atogepant been granted authorization from the Food and Drug Administration?

"Since this is a Phase 1 trial with limited evidence for both safety and efficacy, Atogepant receives an estimated score of 1."

Answered by AI

How many participants are there in this clinical experiment?

"Indeed, information from clinicaltrials.gov suggests that this trial is actively enlisting participants. The initial posting for the study was on June 26th 2023 and has been revised as of June 30th 2023. They are seeking 24 volunteers across one centre."

Answered by AI

Who has the opportunity to participate in this research effort?

"This research endeavour is welcoming 24 participants aged between 18-45 who maintain a state of health. To be eligible, volunteers must meet additional criteria including delivery without complications at 37-42 weeks gestation, consent to using pasteurized donor milk or previously pumped/stored breastmilk for their infant and agreement with the use of provided pumps during collection."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers

2023. "Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05892757.

All > Montreal