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

Sponsor
Danish Headache Center
Study ID
NCT05211154
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Diclofenac Potassium 50Mg/Pkt Oral Pwdr — DRUG
    Treatment for an acute, moderate to severe migraine attack
  • Rimegepant 75 MG — DRUG
    Treatment for an acute, moderate to severe migraine attack

Study Details

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.

Key Dates

Start date
May 5, 2022
Status verified
Sep 2025
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
300 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Diclofenac Potassium (soluble)
    50 mg diclofenac potassium taken orally once
  • Active Comparator: Rimegepant
    75 mg rimegepant taken orally once

Primary Outcome Measure

Pain freedom at 2 hours [ Time Frame: 2 hours after initial dose ]

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