Migraine Without Aura Clinical Trial
Official title:
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)
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.
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. ;
| NCT number | NCT05211154 |
| Study type | Interventional |
| Source | Danish Headache Center |
| Contact | Messoud Ashina, Prof. |
| Phone | 004538633385 |
| [email protected] | |
| Status | Recruiting |
| Phase | Phase 4 |
| Start date | May 5, 2022 |
| Completion date | December 2025 |
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