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Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

Ubrogepant for Migraine (TANDEM Trial)

Phase 4

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 up to approximately 28 weeks

Awards & highlights

TANDEM Trial Summary

This trial will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine.

Eligible Conditions

Migraine with Aura

TANDEM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 28 weeks for reporting.

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 Columbia-Suicide Severity Rating Scale (C-SSRS)

Number of Participants With Adverse Events (AEs)

Percentage of Participants With Clinically Significant Change in Laboratory Values as assessed by the Investigator

+2 more

TANDEM Trial Design

1Treatment groups

Experimental Treatment

Group I: Atogepant + UbrogepantExperimental Treatment2 Interventions

Participants will receive atogepant for 12 weeks followed by atogepant + ubrogepant for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atogepant

2018

Completed Phase 4

~3490

Ubrogepant

2016

Completed Phase 4

~4990

Do I qualify?Apply below to find out

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Who is running the clinical trial?

AllerganLead Sponsor

781 Previous Clinical Trials

275,542 Total Patients Enrolled

10 Trials studying Migraine

5,105 Patients Enrolled for Migraine

AbbVieLead Sponsor

952 Previous Clinical Trials

499,507 Total Patients Enrolled

10 Trials studying Migraine

6,895 Patients Enrolled for Migraine

ALLERGAN INC.Study DirectorAllergan

75 Previous Clinical Trials

78,232 Total Patients Enrolled

5 Trials studying Migraine

3,923 Patients Enrolled for Migraine

Frequently Asked Questions

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

What is the latest update on Ubrogepant's FDA approval process?

"Ubrogepant is a phase 4 drug, so it has been approved and is safe to use."

Answered by AI

Can people with the required qualifications still join this experiment?

"The information available on clinicaltrials.gov tells us that this study is not, at this time, looking for more patients. The trial was initially posted on March 7th, 2022 and was last updated on September 26th, 2022. There are, however, 168 other trials that are actively recruiting."

Answered by AI

Does this research include individuals over the age of 55?

"This particular clinical trial requires that patients seeking to enroll are between 18-80 years old."

Answered by AI

Who can join this study and what are the requirements?

"This study is currently enrolling 263 individuals, both male and female, who have been experiencing sick headaches for at least a year. These patients must also have a history of 4-14 migraines days per month in the 3 months leading up to the screening process."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

2022. "Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05264129.