NCT05211154

Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Danish Headache Center · 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 50 mg diclofenac potassium is non-inferior to 75 mg rimegepant in terms of pain freedom at 2 hours after drug intake.

Detailed description

The study design is a randomized, open-label, parallel-group, single-attack study with 50 mg diclofenac potassium and 75 mg rimegepant. 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	Diclofenac Potassium 50Mg/Pkt Oral Pwdr	Treatment for an acute, moderate to severe migraine attack
DRUG	Rimegepant 75 MG	Treatment for an acute, moderate to severe migraine attack

Timeline

• Start date: 2022-05-05
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2022-01-27
• Last updated: 2025-09-29

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated drug study