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

Inclusion Criteria:

• Subject has provided informed consent prior to initiation of any study-specificactivities/procedures.
• Aged 18 to 65 years upon entry into screening
• History of migraine (with or without aura) for greater than or equal to 12 monthsbefore screening according to the ICHD-3 criteria based on medical records and/orpatient self-report.
• Not more than 12 attacks per month with moderate to severe headache pain in each ofthe 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, orcombination 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 6months. Other Medical Conditions
• The subject is at risk of self-harm or harm to others as evidenced by past suicidalbehavior
• 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 ofinvestigational product; participants with prior gastric bariatric interventions whichhave been reversed are not excluded.
• Has a history of malignancy in the prior 5 years, except for adequately treated basalcell 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 posea risk to subject safety or interfere with the study evaluation, procedures orcompletion 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 generelated piptide (CGRP) or CGRP receptors, or current use of small-molecule CGRPreceptor antagonist (e.g. erenumab, fremanezumab, galcaneszumab, atogeptant orrimegepant)
• Changes in treatment with selective serotonin reuptake inhibitors (SSRI) or serotoninnorepinephrine 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 notlimited 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 atscreening or day 1 by a urine pregnancy test.
• Female subject is pregnant or breastfeeding or planning to become pregnant orbreastfeed during treatment and for an additional 16 weeks after the last dose ofinvestigational product.
• Female subjects of childbearing potential unwilling to use 1 acceptable method ofeffective contraception during treatment and for an additional 16 weeks after the lastdose of investigational product.
• Evidence of current pregnancy or breastfeeding per subject self-report or medicalrecords
• Subject has known sensitivity to any of the products or components to be administeredduring dosing.
• Subject likely to not be available to complete all protocol-required study visits orprocedures, and/or to comply with all required study procedures (e.g, Clinical OutcomeAssessments) to the best of the subject and investigator's knowledge.