This trial – ClinicalTrials.gov ID # NCT00573170 – will be recruiting at 97 centers across the U.S. It will be evaluating the effectiveness of the drug TREXIMATM by comparison with butalbital-containing combination medications for acute treatment of migraine. For information and contact information, see the ClinicalTrials.gov listing.
Importantly, subjects must have an active prescription for and be using a butalbital-containing medication as their primary treatment of medication.
The introduction to the study description at ClinicalTrials.gov is as follows:
"This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMA will be compared to a butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet]) for the acute treatment of migraine headaches. "Subjects will be randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT). Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. (T = TREXIMA; P = placebo; B = butalbital) "The study will include 4 visits: (1) a Screening visit at study entry, (2) a Drug Screen visit, (3) a Randomization visit, (4) a Final visit. The Final visit occurs either (A) upon withdrawal, or (B), after treatment of 3 migraine attacks, or C) if the study concludes prior to the subject treating 3 attacks. "The primary objective is to evaluate the efficacy of TREXIMA versus BCM for the acute treatment of moderate/severe migraine."