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Efficacy of Sumatriptan With Naprosyn in Migraine With Aura

Primary Purpose

Migraine With Aura

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sumatriptan with naprosyn
placebo
Sponsored by
Dent Neurologic Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With Aura focused on measuring migraine, migraine with aura, headache

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dent Neurologic InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Placebo taken at onset of aura associated with migraine.

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

Outcomes

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).

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2009
Last Updated
February 18, 2015
Sponsor
Dent Neurologic Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00893594
Brief Title
Efficacy of Sumatriptan With Naprosyn in 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 Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dent Neurologic Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura
Keywords
migraine, migraine with aura, headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo taken at onset of aura associated with migraine.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sumatriptan with naprosyn taken at onset of aura associated with migraine.
Intervention Type
Drug
Intervention Name(s)
sumatriptan with naprosyn
Other Intervention Name(s)
Treximet
Intervention Description
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
Intervention Name(s)
placebo
Intervention Description
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 Information:
Title
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
Secondary Outcome Measure Information:
Title
Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours.
Time Frame
2 and 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary K Betz, MS
Phone
716-250-2000
Email
mbetz@dentinstitute.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Hogan, BS
Phone
716-558-5670
Email
rhogan@dentinstitute.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laszlo L Mechtler, MD
Organizational Affiliation
Dent Neurologic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca M Hogan, BS
Phone
716-558-5670
Email
rhogan@dentinstitute.com
First Name & Middle Initial & Last Name & Degree
Mary K Betz, P.A.
Phone
716-558-5662
Email
mbetz@dentinstitute.com
First Name & Middle Initial & Last Name & Degree
Laszlo L Mechtler, M.D.

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Sumatriptan With Naprosyn in Migraine With Aura

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