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

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517128-21-02

Enrollment

645

Registered

2025-01-29

Start date

2022-05-04

Completion date

2025-04-30

Last updated

2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Brief summary

The percentage of subjects who become pain free at 2 hours(h) after treatment, before the use of any rescue medication is the primary measure of efficacy.

Detailed description

Absence of the most bothersome symptom (MBS) at 2 hours, Relapse, Headache intensity, Rescue medication, Global evaluation, Associated symptom – nausea, Associated symptom – photophobia, Associated symptom – phonophobia, Adverse events

Interventions

DRUGVOLTFAST 50 mg granulato per soluzione orale

DRUGVYDURA 75 mg oral lyophilisate

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The percentage of subjects who become pain free at 2 hours(h) after treatment, before the use of any rescue medication is the primary measure of efficacy.	—

Secondary

Measure	Time frame
Absence of the most bothersome symptom (MBS) at 2 hours, Relapse, Headache intensity, Rescue medication, Global evaluation, Associated symptom – nausea, Associated symptom – photophobia, Associated symptom – phonophobia, Adverse events	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026