Efficacy of Sumatriptan With Naprosyn in Migraine With Aura
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| ClinicalTrials.gov Identifier: NCT00893594 |
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Recruitment Status : Unknown
Verified February 2015 by Mary Kay Betz, MS RPA-C, Dent Neurologic Institute.
Recruitment status was: Recruiting
First Posted : May 6, 2009
Last Update Posted : February 19, 2015
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Sponsor:
Dent Neurologic Institute
Information provided by (Responsible Party):
Mary Kay Betz, MS RPA-C, Dent Neurologic Institute
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Brief Summary:
This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Migraine With Aura | Drug: sumatriptan with naprosyn Drug: placebo | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | October 2010 |
| Estimated Primary Completion Date : | December 2015 |
| Estimated Study Completion Date : | December 2015 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 1
Placebo taken at onset of aura associated with migraine.
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Drug: 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. |
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Active Comparator: 2
Sumatriptan with naprosyn taken at onset of aura associated with migraine.
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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.
Other Name: Treximet |
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). [ Time Frame: 2 and 4 hours ]
Secondary Outcome Measures :
- Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours. [ Time Frame: 2 and 4 hours ]
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893594
Contacts
| Contact: Mary K Betz, MS | 716-250-2000 | mbetz@dentinstitute.com | |
| Contact: Rebecca Hogan, BS | 716-558-5670 | rhogan@dentinstitute.com |
Locations
| United States, New York | |
| Dent Neurologic Institute | Recruiting |
| Amherst, New York, United States, 14226 | |
| Contact: Rebecca M Hogan, BS 716-558-5670 rhogan@dentinstitute.com | |
| Contact: Mary K Betz, P.A. 716-558-5662 mbetz@dentinstitute.com | |
| Principal Investigator: Laszlo L Mechtler, M.D. | |
Sponsors and Collaborators
Dent Neurologic Institute
Investigators
| Principal Investigator: | Laszlo L Mechtler, MD | Dent Neurologic Institute |
| Responsible Party: | Mary Kay Betz, MS RPA-C, Physician Assistant, Dent Neurologic Institute |
| ClinicalTrials.gov Identifier: | NCT00893594 History of Changes |
| Other Study ID Numbers: |
113010 |
| First Posted: | May 6, 2009 Key Record Dates |
| Last Update Posted: | February 19, 2015 |
| Last Verified: | February 2015 |
Keywords provided by Mary Kay Betz, MS RPA-C, Dent Neurologic Institute:
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migraine migraine with aura headache |
Additional relevant MeSH terms:
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Migraine Disorders Migraine with Aura Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Sumatriptan Naproxen Vasoconstrictor Agents Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors |