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NCT05264129 · ClinicalTrials.gov registry record · Phase 4
Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine
A Phase 4 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 4
- Development phase
- 263
- Enrollment target
NCT05264129: Completed Phase 4 study, sponsored by AbbVie.
NCT05264129 is a Phase 4 study that has completed, run by AbbVie. The registered enrollment target is 263 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05264129, a Phase 4 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 263 participants
- Enrollment target
Study Summary
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study 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. Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of migraine. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States. Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event
Interventions
- DRUG Ubrogepant
- DRUG Atogepant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2023-04-04 |
| Phase | Phase 4 |
What the finished NCT05264129 record still lists
NCT05264129 is an interventional study that assigns participants to a tested intervention. The registered 263 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which Ubrogepant is the first listed.
NCT05264129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05264129 about?
NCT05264129 is a clinical study titled "Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine". Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants t...
What is the current status of trial NCT05264129?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 263 participants. The study started on 2022-03-07. Estimated completion is 2023-04-04.
What interventions are being tested in trial NCT05264129?
The interventions under investigation include: Ubrogepant (DRUG), Atogepant (DRUG).
Who is sponsoring clinical trial NCT05264129?
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 NCT05264129's enrollment target sits among peer trials
263 323rd of 2000 higher than 1,678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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