Efficacy of Sumatriptan With Naprosyn in Migraine With Aura

Condition(s) targeted: Migraine With Aura

Intervention: sumatriptan with naprosyn (Drug); placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Dent Neurologic Institute

Official(s) and/or principal investigator(s):
Laszlo L Mechtler, MD, Principal Investigator, Affiliation: Dent Neurologic Institute

Overall contact:
Mary K Betz, MS, Phone: 716-250-2000, Email: mbetz@dentinstitute.com

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

Official title: A Parallel Two Arm, Double Blinded Placebo Study, Examining the Efficacy of Sumatriptan With Naprosyn in the Treatment of Migraine With Aura

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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).

Secondary outcome: Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Mary K Betz, MS, Phone: 716-250-2000, Email: mbetz@dentinstitute.com

Dent Neurologic Institute, Amherst, New York 14226, United States; Recruiting
Olga I Ananina, BS, CRC, Phone: 716-558-5670, Email: oananina@dentinstitute.com
Mary K Betz, P.A., Phone: 716-558-5662, Email: mbetz@dentinstitute.com
Laszlo L Mechtler, M.D., Principal Investigator

Starting date: October 2010
Last updated: February 16, 2012