Loading clinical trials...
Loading clinical trials...
A Phase 1b, Open-label, Fixed-sequence, Safety, Tolerability and Drug-drug Interaction Study Between Atogepant and Ubrogepant in Participants With a History of Migraine
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine. Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States. Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
PPD Clinical Research Unit /ID# 227676
Orlando, Florida, United States
Bio-Kinetic Clinical Applications, LLC /ID# 227675
Springfield, Missouri, United States
Spaulding Clinical Research LLC /ID# 229505
West Bend, Wisconsin, United States
Start Date
March 17, 2021
Primary Completion Date
June 18, 2021
Completion Date
June 18, 2021
Last Updated
June 16, 2022
26
ACTUAL participants
Atogepant
DRUG
Ubrogepant
DRUG
Lead Sponsor
AbbVie
NCT06641466
NCT07018713
NCT04715685
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions