Efficacy of Sumatriptan With Naprosyn in Migraine With Aura

This study is currently recruiting participants.
Verified February 2014 by Dent Neurologic Institute
Sponsor:
Information provided by (Responsible Party):
Mary Kay Betz, MS RPA-C, Dent Neurologic Institute
ClinicalTrials.gov Identifier:
NCT00893594
First received: May 4, 2009
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Migraine With Aura
Drug: sumatriptan with naprosyn
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Dent Neurologic Institute:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours. [ Time Frame: 2 and 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo taken at onset of aura associated with migraine.
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.
Active Comparator: 2
Sumatriptan with naprosyn taken at onset of aura associated with migraine.
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893594

Contacts
Contact: Mary K Betz, MS 716-250-2000 mbetz@dentinstitute.com
Contact: Olga I Ananina, BS, CRC 716-558-5670 oananina@dentinstitute.com

Locations
United States, New York
Dent Neurologic Institute Recruiting
Amherst, New York, United States, 14226
Contact: Olga I Ananina, BS, CRC    716-558-5670    oananina@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
  More Information

No publications provided

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
Study First Received: May 4, 2009
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration
United States: International Conference on Harmonization Good Clinical Practice Guidelines
United States: Department of Health and Human Services
Canada: Part C Division 5 of the Canadian Food and Drug Regulations
Canada: Tri-Council Policy Statement (TCPS)

Keywords provided by Dent Neurologic Institute:
migraine
migraine with aura
headache

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Naproxen
Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 14, 2014