TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults

Summary

Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)

Timeline

Start

2008-02

Primary completion

2009-08

Completion

2009-08

Outcome

Missed primary endpoint

paper This study did not detect a difference at the nominal 0.05 level in percent sustained pain-free between SumaRT/Nap (8%), BCM (6%), and placebo (3%). PMID 22103635 ↗

registry p = 0.378; Odds Ratio (OR) 1.3 (95% CI 0.7 to 2.5) NCT00573170 ↗

Publications

• Background Silberstein SD, McCrory DC. Butalbital in the treatment of headache: history, pharmacology, and efficacy. Headache. 2001 Nov-Dec;41(10):953-67. doi: 10.1046/j.1526-4610.2001.01189.x.
• Background Bigal ME, Rapoport AM, Sheftell FD, Tepper SJ, Lipton RB. Transformed migraine and medication overuse in a tertiary headache centre--clinical characteristics and treatment outcomes. Cephalalgia. 2004 Jun;24(6):483-90. doi: 10.1111/j.1468-2982.2004.00691.x.
• Background Wenzel RG, Sarvis CA. Do butalbital-containing products have a role in the management of migraine? Pharmacotherapy. 2002 Aug;22(8):1029-35. doi: 10.1592/phco.22.12.1029.33595.
• Derosier F, Sheftell F, Silberstein S, Cady R, Ruoff G, Krishen A, Peykamian M. Sumatriptan-naproxen and butalbital: a double-blind, placebo-controlled crossover study. Headache. 2012 Apr;52(4):530-43. doi: 10.1111/j.1526-4610.2011.02039.x. Epub 2011 Nov 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	325 mg	—
Subject	Caffeine	Small molecule	40 mg	—
Subject	Naproxen	Small molecule	500 mg	—
Subject	Sumatriptan	Unknown	85 mg	—
Subject	butalbital	Small molecule	50 mg	—

Indications