NCT05264129

Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of the Concomitant Use of Ubrogepant for the Acute Treatment of Migraine in Subjects Taking Atogepant for the Preventive Treatment of Episodic Migraine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Episodic Migraine

Interventions

Type	Name	Description
DRUG	Atogepant	Oral Tablet
DRUG	Ubrogepant	Oral Tablet

Timeline

• Start date: 2022-03-07
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2022-03-03
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated drug study