Efficacy of Sumatriptan With Naprosyn in Migraine With Aura

Migraine With Aura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00893594
• Other study ID #: 113010
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2009
• Last updated: February 18, 2015
• Start date: October 2010
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Dent Neurologic Institute
• Contact: Mary K Betz, MS
• Phone: 716-250-2000
• Email: mbetz[@]dentinstitute.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: International Conference on Harmonization Good Clinical Practice GuidelinesUnited States: Department of Health and Human ServicesCanada: Part C Division 5 of the Canadian Food and Drug RegulationsCanada: Tri-Council Policy Statement (TCPS)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Dent Neurologic Institute	Amherst	New York

Sponsors (1)

Lead Sponsor	Collaborator
Dent Neurologic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		2 and 4 hours	No
Secondary	Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours.		2 and 4 hours	No