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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 is a Phase 4 study that has completed, run by AbbVie. The registered enrollment target is 263 participants.

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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.

Interventions

  • DRUG Ubrogepant
  • DRUG Atogepant

Trial Details

FieldValue
Enrollment Target 263 participants
Start Date 2022-03-07
Est. Completion 2023-04-04
Phase Phase 4

Sponsor

AbbVie

526 total trials

What the Registry Record Tells You About NCT05264129

The ClinicalTrials.gov registry entry for NCT05264129 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 263 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.

NCT05264129 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.