Efficacy of Sumatriptan With Naprosyn in Migraine With Aura

NCT ID: NCT00893594

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-12-31

Brief Summary

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

Conditions

Migraine With Aura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Placebo taken at onset of aura associated with migraine.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

2

Sumatriptan with naprosyn taken at onset of aura associated with migraine.

Group Type: ACTIVE_COMPARATOR

sumatriptan with naprosyn

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Treximet

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dent Neurologic Institute

OTHER

Sponsor Role: lead

Responsible Party

Mary Kay Betz, MS RPA-C

Physician Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laszlo L Mechtler, MD

Role: PRINCIPAL_INVESTIGATOR

Dent Neurologic Institute

Locations

Dent Neurologic Institute

Amherst, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary K Betz, MS

Role: CONTACT

mbetz@dentinstitute.com

716-250-2000

Rebecca Hogan, BS

Role: CONTACT

rhogan@dentinstitute.com

716-558-5670

Facility Contacts

Rebecca M Hogan, BS

Role: primary

rhogan@dentinstitute.com

716-558-5670

Mary K Betz, P.A.

Role: backup

mbetz@dentinstitute.com

716-558-5662

Other Identifiers

113010

Identifier Type: -

Identifier Source: org_study_id