Migraine Treatment Satisfaction With Treximet Versus Concomitant 2 Aleve and Imitrex

NCT01450995 | Completed Phase 4 DMC

• 1 other identifier: 113403
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, 6 month cross over study in 50 migraine patients fulfilling International Headache Society Classification criteria for migraine headache with and without aura having 2-6 migraines per month and not over 14 days a month of headaches in the previous 3 months. Baseline Headache Impact Test -6 (HIT-6) will be obtained and 25 patients will administer Treximet as needed for 3 months and then 2 Aleve and 100mg Imitrex taken concomitantly as needed for 3 months. The other 25 patients will administer 2 Aleve and 100mg Imitrex taken concomitantly as needed for 3 months and then Treximet as needed for 3 months. In addition to Revised Patient Perception of Migraine Questionnaire (PPMQ-R)data, a detailed diary will be recorded regarding number of tablets taken per attack, compliance, rescue treatment, when patients treated their migraine attack (mild, moderate, or severe), onset of pain reduction (pain relief and pain free, and 24 hour pain relief and sustained pain free response.

Conditions

Migraine

Keywords

Migraine; Headache, Migraine

Outcome Measures

Primary Outcomes (1)

• Measurement of patient satisfaction of Treximet vs 2 Aleve and 100mg Imitrex

  one year

Secondary Outcomes (4)

• Measurement of time to onset of pain relief

  One year

• Measurement of time to onset of pain free

  one year

• Measurement of 24 hour sustained pain free

  One year

• Measurement of 24 hour sustained pain relief

  One year

Study Arms (2)

Treximet

ACTIVE COMPARATOR

Drug: Treximet

Imitrex and Aleve

ACTIVE COMPARATOR

Drug: Imitrex and two Aleve

Interventions

Treximet DRUG

Tablet form, one tablet dose, one tablet at migraine onset with second tablet for persistent or recurring migraine two hours after first dose.

Treximet

Imitrex and two Aleve DRUG

Imitrex tablet, one tablet dose, Aleve tablets, 2 220 mg tablet dose. Three tablets taken concurrently with migraine onset. Second dose of tablets may be taken if migraine persists for two hours

Imitrex and Aleve

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female.
• Subject is age 18 to 65.
• A female is eligible to enter and participate in this study if she is not breast feeding and is of: non-childbearing potential (i.e. physiologically incapable of becoming pregnant) or child-bearing potential, has a negative urine pregnancy test at screening and agrees to use an acceptable method of contraception during the course of the study or, Female sterilization; or, Sterilization of male partner; or Implants of levonorgestrel; or Injectable progestogen; or Oral contraceptive (combined or progestogen only); or Any intrauterine device (IUD) meet this criterion; or Double barrier method; or Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year
• Subject has a diagnosis of migraine and meets IHS criteria for migraine with or without aura (1.1) or migraine with aura (1.2)
• Subject has at least a 1-year history of migraine with 2-6 migraines per month in the three months prior to screening
• Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
• Subject is able to read, understand and complete diaries, subject questionnaires and the instructions for the study.
• Subject is able and willing to give written informed consent to participate in the study.

You may not qualify if:

• Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina, or signs/symptoms consistent with any of the above.
• Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome.
• Subject has cardiac arrhythmias requiring medication or a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
• Subject has a history of cerebrovascular pathology including stroke.
• Subject has a history of congenital heart disease.
• Subject has uncontrolled hypertension at screening (sitting (\>140 mmHg systolic pressure or \>90mmHg diastolic pressure).
• Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
• Subject has significant peripheral vascular disease
• Subject is currently taking any anti-coagulant (e.g., Coumadin®).
• Subject has a history of inflammatory bowel disease.
• Subject has a history of any bleeding disorder.
• Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
• Subject is taking any antiplatelet agent (except low-dose aspiring ≤ 325 mg/day for cardioprotective reasons).
• Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
• Subject has a history of epilepsy.

Sponsors & Collaborators

• Stephen H. Landy, M.D.: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Wesley Headache Clinic

Memphis, Tennessee, 38018, United States

Location

Related Publications (6)

• Revicki DA, Kimel M, Beusterien K, Kwong JW, Varner JA, Ames MH, Mahajan S, Cady RK. Validation of the revised Patient Perception of Migraine Questionnaire: measuring satisfaction with acute migraine treatment. Headache. 2006 Feb;46(2):240-52. doi: 10.1111/j.1526-4610.2006.00289.x.

  PMID: 16492233 RESULT

• Landy S, DeRossett SE, Rapoport A, Rothrock J, Ames MH, McDonald SA, Burch SP. Two double-blind, multicenter, randomized, placebo-controlled, single-dose studies of sumatriptan/naproxen sodium in the acute treatment of migraine: function, productivity, and satisfaction outcomes. MedGenMed. 2007 Jun 7;9(2):53.

  PMID: 17955107 RESULT

• Smith T, Blumenthal H, Diamond M, Mauskop A, Ames M, McDonald S, Lener S, Burch S. Sumatriptan/Naproxen sodium for migraine: efficacy, health related quality of life, and satisfaction outcomes. Headache. 2007 May;47(5):683-92. doi: 10.1111/j.1526-4610.2007.00790.x.

  PMID: 17501849 RESULT

• 4. Cady RK, et al. Consistent medication satisfaction with sumatriptan RT Technology and naproxen sodium for acute migraine treatment. Poster presented at 13th Congress of the International Headache Society (IHS), June 28-July 1, 2007; Stockholm, Sweden.

  RESULT

• Mathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.

  PMID: 19486178 RESULT

• Kimel M, Hsieh R, McCormack J, Burch SP, Revicki DA. Validation of the revised Patient Perception of Migraine Questionnaire (PPMQ-R): measuring satisfaction with acute migraine treatment in clinical trials. Cephalalgia. 2008 May;28(5):510-23. doi: 10.1111/j.1468-2982.2007.01524.x. Epub 2008 Mar 31.

  PMID: 18384420 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

sumatriptan-naproxen; Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stephen H Landy, M.D.

  Wesley Headache Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: October 13, 2011
• Study Start: December 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 13, 2011

Record last verified: 2011-10

Locations

US (1)