- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00893594
Efficacy of Sumatriptan With Naprosyn in Migraine With Aura
February 18, 2015 updated by: Mary Kay Betz, MS RPA-C, Dent Neurologic Institute
A Parallel Two Arm, Double Blinded Placebo Study, Examining the Efficacy of Sumatriptan With Naprosyn in the Treatment of Migraine With Aura
This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mary K Betz, MS
- Phone Number: 716-250-2000
- Email: mbetz@dentinstitute.com
Study Contact Backup
- Name: Rebecca Hogan, BS
- Phone Number: 716-558-5670
- Email: rhogan@dentinstitute.com
Study Locations
-
-
New York
-
Amherst, New York, United States, 14226
- Recruiting
- Dent Neurologic Institute
-
Contact:
- Rebecca M Hogan, BS
- Phone Number: 716-558-5670
- Email: rhogan@dentinstitute.com
-
Contact:
- Mary K Betz, P.A.
- Phone Number: 716-558-5662
- Email: mbetz@dentinstitute.com
-
Principal Investigator:
- Laszlo L Mechtler, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Placebo taken at onset of aura associated with migraine.
|
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.
|
Active Comparator: 2
Sumatriptan with naprosyn taken at onset of aura associated with migraine.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 and 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours.
Time Frame: 2 and 4 hours
|
2 and 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laszlo L Mechtler, MD, Dent Neurologic Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
May 4, 2009
First Submitted That Met QC Criteria
May 5, 2009
First Posted (Estimate)
May 6, 2009
Study Record Updates
Last Update Posted (Estimate)
February 19, 2015
Last Update Submitted That Met QC Criteria
February 18, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Migraine with Aura
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Serotonin Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Gout Suppressants
- Vasoconstrictor Agents
- Naproxen
- Sumatriptan
Other Study ID Numbers
- 113010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine With Aura
-
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-
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