NCT05214001

Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine

A Randomized, Parallel-Group, Single-Attack, Open-Label Study to Evaluate the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine (ATOM).

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Messoud Ashina, MD · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In a real-world population of adults with migraine, the investigators would like to investigate whether 12.5 mg almotriptan is non-inferior to 50 mg ubrogepant in terms of pain freedom at 2 hours after drug intake.

Detailed description

The study is a randomized, open-label, parallel-group, single-attack study with 12.5 mg almotriptan and 50 mg ubrogepant. 645 patients with migraine with or without aura according to the third edition of the International Classification of Headache Disorders (ICHD-3) will be included. Each subject will randomly be allocated to one treatment, and given 42 days to treat a single qualifying migraine attack of moderate to severe intensity.

Conditions

• Migraine With Aura
• Migraine Without Aura

Interventions

Type	Name	Description
DRUG	Almotriptan 12.5 Mg Oral Tablet	Treatment for an acute, moderate to severe migraine attack
DRUG	Ubrogepant 50Mg Tab	Treatment for an acute, moderate to severe migraine attack

Timeline

• Start date: 2022-06-30
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2022-01-28
• Last updated: 2025-05-31

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated drug study