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

NCT05211154 | Terminated Phase 4 DMC FDA Drug

• 2 other identifiers: 2602212021-001057-31
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine With Aura; Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

• Pain freedom at 2 hours

  Pain freedom will be subjectively rated by the patient in a headache diary

  2 hours after initial dose

Other Outcomes (9)

• Absence of the most bothersome symptom (MBS) at 2 hours

  2 hours after initial dose

• Relapse

  48 hours after initial dose

• Headache intensity

  Predose, and 0.5, 1, 1.5, 2, 3, 4, 12, 24 and 48 hours after initial dose

Study Arms (2)

Diclofenac Potassium (soluble)

EXPERIMENTAL

50 mg diclofenac potassium taken orally once

Drug: Diclofenac Potassium 50Mg/Pkt Oral Pwdr

Rimegepant

ACTIVE COMPARATOR

75 mg rimegepant taken orally once

Drug: Rimegepant 75 MG

Interventions

Diclofenac Potassium 50Mg/Pkt Oral Pwdr DRUG

Treatment for an acute, moderate to severe migraine attack

Also known as: Voltfast

Diclofenac Potassium (soluble)

Rimegepant 75 MG DRUG

Treatment for an acute, moderate to severe migraine attack

Rimegepant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
• Aged 18 to 65 years upon entry into screening
• History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the ICHD-3 criteria based on medical records and/or patient self-report.
• Not more than 12 attacks per month with moderate to severe headache pain in each of the previous 3 months.

You may not qualify if:

• Disease Related
• Greater than 50 years of age at migraine onset
• History of cluster headache or hemiplegic migraine headache
• Inability to differentiate between migraine from other headaches
• Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per months in the previous 3 months
• Has a history of migraine aura with diplopia or impairment of levels of consciousness, hemiplegic migraine, or retinal migraine.
• Required hospital treatment of a migraine attack 3 or more times in the previous 6 months.
• Other Medical Conditions
• The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
• Has a chronic non-headache pain condition requiring daily pain medication
• Has a history of any prior gastrointestinal conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded.
• Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
• History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Medication related
• Start of new preventive migraine treatment within the last two months

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine with Aura; Migraine without Aura

Interventions

Diclofenac; rimegepant sulfate

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Messoud Ashina, Prof.

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 27, 2022
• Study Start: May 5, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)