Efficacy of Sumatriptan With Naprosyn in Migraine With Aura

NCT00893594 | Unknown

• 1 other identifier: 113010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine With Aura

Keywords

migraine; migraine with aura; headache

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  2 and 4 hours

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo taken at onset of aura associated with migraine.

Drug: placebo

2

ACTIVE COMPARATOR

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

Drug: sumatriptan with naprosyn

Interventions

sumatriptan with naprosyn DRUG

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.

Also known as: Treximet

2

placebo DRUG

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.

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dent Neurologic Institute: lead

Study Sites (1)

Dent Neurologic Institute

Amherst, New York, 14226, United States

RECRUITING

MeSH Terms

Conditions

Migraine with Aura; Migraine Disorders; Headache

Interventions

Sumatriptan; Naproxen; sumatriptan-naproxen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Laszlo L Mechtler, MD

  Dent Neurologic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary K Betz, MS

CONTACT

716-250-2000; mbetz@dentinstitute.com

Rebecca Hogan, BS

CONTACT

716-558-5670; rhogan@dentinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Assistant

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 6, 2009
• Study Start: October 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 19, 2015

Record last verified: 2015-02

Locations

US (1)