Recruiting

Sumatriptan with Naprosyn

Sponsor:

Dent Neurologic Institute

Code:

NCT00893594

Conditions

Migraine With Aura

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

sumatriptan with naprosyn

placebo

Study Details

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 ID

NCT00893594

Start date

Oct, 2010

Status verified date

Feb, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: 1

Placebo taken at onset of aura associated with migraine.

active comparator: 2

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

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.

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Mary K Betz, MS

716-250-2000mbetz@dentinstitute.com

Rebecca Hogan, BS

716-558-5670rhogan@dentinstitute.com

Locations

Dent Neurologic Institute

Recruiting

Amherst, New York, United States, 14226

Contacts

Rebecca M Hogan, BS

716-558-5670rhogan@dentinstitute.com

Mary K Betz, P.A.

716-558-5662mbetz@dentinstitute.com

Principal Investigator:

Laszlo L Mechtler, M.D.

More Information

Sponsor

Dent Neurologic Institute

Last update posted

Feb 19, 2015

Last verified

Feb, 2015

Keywords

  • migraine
  • migraine with aura
  • headache

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dent Neurologic Institute on 2015-02-19.