Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Provide written informed consent
Males and females aged 18-65 who can read, write and understand English
Subject has at least a one year documented history of migraine headache (defined by International headache Society IHS) migraine definitions, with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit
Is stable on the current standard non-opioid rescue medication for at least 2 months prior to randomization
Can distinguish migraine from tension headache (HA), with 24 hours of freedom from HA between migraine events
Women of childbearing potential must be currently using or willing to use contraception (30 days prior to start of study medication and for 21 days after taking study medication)
Women of non-childbearing potential include females regardless of age, with functioning ovaries and who have a current documented tubal ligation [Hatcher, 2004] bilateral oophorectomy or total hysterectomy, or post-menopausal females
The subject is able and willing to perform the assessments and procedures as specified in this protocol, including the ability to learn and follow instructions for ePRO device

Exclusion Criteria:

Migraineurs taking opioid-based rescue medications for any indication
Subject has history of mild migraine events or migraines that usually resolve spontaneously in less than 2 hours
Subject has menstrual migraines
Positive Drug Test
Subject has basilar or hemiplegic migraines
Subject has more than 15 headache-days per month
Subjects with a history of facial allodynia
Subject has a history of vomiting during more than 30% of migraine episodes
Self confinement to bed rest for more than 50% of migraine episodes
Subject was greater than 50 years old at age of migraine onset
Acute coronary syndrome (i.e., myocardial infarction and unstable angina), stroke or resuscitated cardiac arrest within the past 3 months
Severe congestive heart failure
Systolic blood pressure (sBP) >160 mmHg or diastolic blood pressure (dBP) >100 mmHg measured in the sitting position at Visit 1
Current active renal disease
Any history of pyelonephritis
Evidence of active liver disease
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase >2 times the upper limit of the reference range (ULRR), or total bilirubin >1.5 times the ULRR at Visit 1
Past history of acute pancreatitis with current triglycerides 4.56 mmol/L (400 mg/dL) at Visit 1
History of malignancy within the past 3 years, other than non-melanoma skin cancer (i.e., basal or superficial squamous cell carcinoma) and treated cervical cancer in-situ
Any planned major surgery to be performed during the study (e.g., coronary artery bypass surgery, abdominal aortic aneurysm repair, etc.)
Current life-threatening condition
Significant hypersensitivity to NSAIDs (e.g., difficulty swallowing or breathing, tachycardia, anaphylaxis, angioedema or skin reaction)
Pregnancy (defined by positive urine pregnancy test) or lactation at Visit 1, or planning to become pregnant prior to completion of the study
History or suspicion of alcohol or substance abuse (current or past 6 months).
Participation in any clinical trial within 30 days prior to Visit 1
Subjects with a history of hypersensitivity to products containing tiaprofenic acid, suprofen, fenofibrate, oxybenzone, or octocrylene (e.g., sunscreen, perfume)
Subjects with a history of photosensitivity
Any clinically significant abnormality or any reason that the subject may not be able to complete the full study observational period