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This study is being conducted to evaluate the hypothesis that use of Treximet in patients with chronic migraine, when used on a short term daily basis and as rescue for break through attacks, will reduce migraine frequency and impact.
One investigative center will enroll 40 subjects in the US.
At Visit 1, following informed consent, a medical, migraine, and medication history will be collected and a physical and neurological exam with vital signs will be performed. A 12-lead ECG will be completed. Eligible subjects will complete a 1-month Baseline Period and treat migraine with their current preferred treatment of choice. Throughout the study, subjects will complete daily Headache Diaries reporting headache severity and associated symptoms with use of study medication in each 30-day period.
At Visit 2, subjects continuing to meet eligibility criteria will be randomized 1:1 to Treximet or naproxen and provided with medication to treat daily for 30 days. At Visits 3 and 4 subjects will be provided with study medication to treat on 14 or fewer days per month. Subjects will be encouraged to treat their migraine attacks within 1 hour of onset of headache pain and while the pain is still mild. Adverse events will be collected beginning from the first dose of study medication. Subjects exit the study at Visit 5 after a 3-month Treatment Period.
The study provides opportunity to evaluate the usefulness of patient education with a 15-minute DVD concerning the processes of headache evolution and lifestyle changes for better headache management. At Visit 2, subjects will view the DVD in-clinic with a copy provided for at-home viewing. Subjects will complete a Lifestyle Choices for Better Migraine Management Questionnaire at each visit and receive 3 copies to be completed weekly and returned at the following visit.
The Migraine Disability Assessment questionnaire (MIDAS) will be completed at Visits 2 and 5 to determine the level of pain and disability caused by headache.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
sumatriptan/naproxen sodium, Naproxen
Not yet recruiting
Cady, Roger, M.D.
Published on BioPortfolio: 2014-08-27T03:15:05-0400
This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old
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The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets containing only n...
The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at th...
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Inflammation may trigger migraine development through neurovascular reactions in the brain. Most of the migraine patients, particularly the younger ones, do not have any risk factors for this disease....
An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.
A voltage-gated sodium channel subtype that is predominantly expressed in the CENTRAL NERVOUS SYSTEM. Defects in the SCN1A gene which codes for the alpha subunit of this sodium channel are associated with DRAVET SYNDROME, generalized epilepsy with febrile seizures plus, type 2 (GEFS+2), and familial hemiplegic migraine type 3.
A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)
A subtype of migraine disorder, characterized by recurrent attacks of reversible neurological symptoms (aura) that precede or accompany the headache. Aura may include a combination of sensory disturbances, such as blurred VISION; HALLUCINATIONS; VERTIGO; NUMBNESS; and difficulty in concentrating and speaking. Aura is usually followed by features of the COMMON MIGRAINE, such as PHOTOPHOBIA; PHONOPHOBIA; and NAUSEA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)
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