Efficacy of Sumatriptan With Naprosyn in Migraine With Aura - Full Text View

Purpose

This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura.

Condition	Intervention
Migraine With Aura	Drug: sumatriptan with naprosyn Drug: placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Parallel Two Arm, Double Blinded Placebo Study, Examining the Efficacy of Sumatriptan With Naprosyn in the Treatment of Migraine With Aura

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine sporadic hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Naproxen Naproxen sodium Sumatriptan Sumatriptan succinate

U.S. FDA Resources

Further study details as provided by Dent Neurologic Institute:

Primary Outcome Measures:

Primary outcome measure will be comparative percentage of patients pain free at 2 and 4 hours from initiating treatment with placebo vs treatment with Treximet (sumatriptan with naprosyn). [ Time Frame: 2 and 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours. [ Time Frame: 2 and 4 hours ] [ Designated as safety issue: No ]


Estimated Enrollment:	30
Study Start Date:	October 2010
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo taken at onset of aura associated with migraine.	Drug: placebo Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain.
Active Comparator: 2 Sumatriptan with naprosyn taken at onset of aura associated with migraine.	Drug: sumatriptan with naprosyn Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain. Other Name: Treximet

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects must be 18 to 50 years of age, inclusive.
Patients will meet the International Headache Society (IHS) classification criteria for migraine with aura.
Subjects must carry the diagnosis of 1-2 migraine with aura per month for at least three months before study inclusion. and migraine with aura were included in the study
Subjects must have an onset of a visual aura that occurs 15-30 minutes before a migraine headache.
Subjects must be able to understand and complete a migraine diary.
Subjects must be able to distinguish a migraine with aura from other types of headache.
Subjects must be in generally good health as confirmed by medical and medication history, baseline physical and neurological exam and vital signs.
Female subjects must be either a) postmenopausal for one year, b)surgically sterile, c) practicing acceptable birth control for at least one month prior to screening and throughout study, or d) practicing abstinence and agree to continue same throughout study.

Exclusion Criteria:

Subjects who have a significant systemic disease other than migraine that is equally painful or more painful.
Subjects who have other progressive neurological disorders.
Subjects who have more than 8 migraines or 15 headache days per month.
Subjects who have previously taken Treximet and failed due to lack of efficacy or adverse side effects.
Subjects who carry the diagnosis of chronic tension type headache or cluster headache based on the International Headache Society criteria.
Subject should not have received any other investigative drug within 3 months prior to enrollment in the study.
Subject who have the diagnosis of seizure disorder, chronic daily headache, uncontrolled hypertension, cardiovascular disease, history of stroke, basilar or hemiplegic migraine, hepatic disease, or active peptic ulcer disease.
Subjects currently taking or in 3 months prior to study, use of prophylactic migraine medications.
Subjects who have a known allergy to Sumatriptan or Naprosyn.
Subjects who in the opinion of Dr. Mechtler have a condition for which they should not be enrolled in the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893594

Contacts


Contact: Mary K Betz, MS	716-250-2000	mbetz@dentinstitute.com
Contact: Rebecca Hogan, BS	716-558-5670	rhogan@dentinstitute.com

Locations


United States, New York
Dent Neurologic Institute	Recruiting
Amherst, New York, United States, 14226
Contact: Rebecca M Hogan, BS 716-558-5670 rhogan@dentinstitute.com
Contact: Mary K Betz, P.A. 716-558-5662 mbetz@dentinstitute.com
Principal Investigator: Laszlo L Mechtler, M.D.

Sponsors and Collaborators

Dent Neurologic Institute

Investigators


Principal Investigator:	Laszlo L Mechtler, MD	Dent Neurologic Institute

More Information


Responsible Party:	Mary Kay Betz, MS RPA-C, Physician Assistant, Dent Neurologic Institute
ClinicalTrials.gov Identifier:	NCT00893594 History of Changes
Other Study ID Numbers:	113010
Study First Received:	May 4, 2009
Last Updated:	February 18, 2015
Health Authority:	United States: Food and Drug Administration United States: International Conference on Harmonization Good Clinical Practice Guidelines United States: Department of Health and Human Services Canada: Part C Division 5 of the Canadian Food and Drug Regulations Canada: Tri-Council Policy Statement (TCPS)

Keywords provided by Dent Neurologic Institute:


migraine migraine with aura headache

Additional relevant MeSH terms:


Migraine Disorders Migraine with Aura Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Naproxen Sumatriptan Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 26, 2016