Conditions: Migraine Disorders Migraine, Acute
Keywords: Migraine, acute Migraine Butalbital-containing Combination Medication (BCM) Naproxen sodium Sumatriptan succinate TREXIMET®
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 375
Healthy volunteers: no

Brief 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)

Detailed description:
This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMET® 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 where T = TREXIMET®; P = Placebo; B = Butalbital-containing Combination Medication) . Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. The study will include 4 visits: (1) a Screening visit at study entry, (2) a Drug Screen visit, (3) a Randomization visit, and (4) a Final visit. The Final visit occurs either (A) upon withdrawal or (B) after treatment of 3 migraine attacks. The primary objective is to evaluate the efficacy of TREXIMET® versus BCM for the acute treatment of moderate/severe migraine. These two replicate studies were amended while ongoing to allow for the reporting of pooled data only.

Arms:
arm 1: TREXIMET® (Attack 1), placebo (Attack 2), BCM (Attack 3) arm 2: TREXIMET® (Attack 1), BCM (Attack 2), placebo (Attack 3) arm 3: BCM (Attack 1), TREXIMET® (Attack 2), placebo (Attack 3) arm 4: BCM (Attack 1), placebo (Attack 2), TREXIMET® (Attack 3) arm 5: placebo (Attack 1), TREXIMET® (Attack 2), BCM (Attack 3) arm 6: placebo (Attack 1), BCM (Attack 2), TREXIMET® (Attack 3)

Interventions: intervention 1: TREXIMET® intervention 2: Butalbital-containing Combination Medications (BCM) intervention 3: placebo
Intervention descriptions: intervention 1: Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg) intervention 2: butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\] intervention 3: placebo

Protocol document: