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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: Completed Phase 1 study, sponsored by AbbVie.
NCT04818515 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when Ubrogepant is administered.
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 |
What the finished NCT04818515 record still lists
NCT04818515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Ubrogepant is the first listed.
NCT04818515 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04818515's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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