Migraine showdown: which pill stops the pain faster?
NCT ID NCT05211154
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a common painkiller (diclofenac potassium) works as well as a newer migraine drug (rimegepant) for stopping migraine pain within 2 hours. About 300 adults with migraine took one of the two medicines during a single attack. The goal was to see if both offer similar relief, helping patients and doctors choose the best option.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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300 people
The number who actually took part.
- Started
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May 2022
- Finished
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Apr 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: 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 * Change in dosage of ongoing preventive migraine treatment within the last two months * Current preventive treatment with monoclonal antibodies targeting calcitonin gene related piptide (CGRP) or CGRP receptors, or current use of small-molecule CGRP receptor antagonist (e.g. erenumab, fremanezumab, galcaneszumab, atogeptant or rimegepant) * Changes in treatment with selective serotonin reuptake inhibitors (SSRI) or serotonin norepinephrine reuptake inhibitors (SNRI) within the last two months * Use of the following medication within 30 days prior to screening: * Strong and moderate cytochrome P450 3A4 (CYP3A4) inhibitors, including but not limited to systemic (oral/IV) itraconazole, ketoconazole, fluconazole; erythromycin, clarithromycin, telithromycin; diltiazem, verapamil; aprepitant; cyclosporine; nefazodone; cimetidine; quinine; and HIV protease inhibitors * Strong and moderate CYP3A4 inducers, including but not limited to barbiturates (eg, phenobarbital and primidone), systemic (oral/IV) glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, rifampin, rifabutin, and St. John's wort * Inhibitors of the BCRP (breast cancer resistance protein) transporter (eg, rifampicin) * Drugs with narrow therapeutic margins (eg, digoxin, warfarin) Other Exclusions * Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test. * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product. * Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product. * Evidence of current pregnancy or breastfeeding per subject self-report or medical records * Subject has known sensitivity to any of the products or components to be administered during dosing. * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Danish Headache Center
Glostrup Municipality, 2600, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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