Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migr… (NCT05211154) | Clinical Trial Compass
TerminatedPhase 4
Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine
Stopped: Issues with recruitment
Denmark300 participantsStarted 2022-05-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 meta…