NCT01450995

Open-label, 6 Month Crossover Study Evaluating Migraine Patient Satisfaction Comparing Treximet to 2 Aleve and 100mg Imitrex Taken Concomitantly

Completed Phase 4 Last updated 10 October 2011

What this trial tests

Phase 4 trial testing Treximet in Migraine in 50 participants. Completed in 1 May 2011.

Timeline

1 December 2009

Primary endpoint
1 May 2011

1 May 2011

Quick facts

Lead sponsor	Stephen H. Landy, M.D.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 December 2009
Primary completion	1 May 2011
Estimated completion	1 May 2011
Sites	1 location across United States

Drugs / interventions tested

• Treximet — full drug profile →
• Imitrex and two Aleve — full drug profile →

Conditions studied

• Migraine — all drugs for Migraine →

Sponsor

Stephen H. Landy, M.D. — full company profile →

Who can join

Adults 18 to 65, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Measurement of patient satisfaction of Treximet vs 2 Aleve and 100mg Imitrex
  Time frame: one year

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sumatriptan/naproxen sodium combination versus its components administered concomitantly for the acute treatment of migraine: a pragmatic, crossover, open-label outcomes study.
   Landy S, Hoagland R, Hoagland D, Saiers J, et al · · 2013 · cited 5× · PMID 23997813 · DOI 10.1177/1756285613499788