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NCT04818515 · ClinicalTrials.gov registry record · Phase 1
Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT04818515 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 26 participants.
The verdict
NCT04818515, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Ubrogepant
- DRUG Atogepant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2021-06-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04818515
The ClinicalTrials.gov registry entry for NCT04818515 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ubrogepant is the first listed.
NCT04818515 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04818515 about?
NCT04818515 is a clinical study titled "Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult 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 saf...
What is the current status of trial NCT04818515?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2021-03-17. Estimated completion is 2021-06-18.
What interventions are being tested in trial NCT04818515?
The interventions under investigation include: Ubrogepant (DRUG), Atogepant (DRUG).
Who is sponsoring clinical trial NCT04818515?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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