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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In a real-world population of adults with migraine, we 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Headache Center
• Treatments: Diclofenac

Criteria

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 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 or atogeptant)

• 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.