Study TRX109013, TREXIMA™ (Sumatriptan + Naproxen Sodium) Versus Butalbital-Containing Combination Medications (BCM) for the Acute Treatment of Migraine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00599157

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: Trexima Drug: Butalbital-containing Combination Medications (BCM) Drug: butalbital	Phase III

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Caffeine Dietary Sodium Headache Migraine

Drug Information available for: Succinic acid Naproxen Naproxen sodium Acetaminophen Sumatriptan succinate Sumatriptan 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate Butalbital

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Subjects with a sustained pain-free (SPF) response from 2-24 hours in subjects using TREXIMA versus those using BCM [ Time Frame: 2-24 hours ]

Secondary Outcome Measures:

Subjects who are pain-free (PF) at 2 hours post-treatment [ Time Frame: 2-48 hours ]
Effects on cognition of treating with BCM vs TREXIMA (as measured by the Mental Efficiency Workload Test (MEWT), measured at 2, 4, 6, 8, 24, and 48 hours [ Time Frame: 2-48 hours ]
Subjects who use rescue medi [ Time Frame: 2-48 hours ]

Estimated Enrollment:	500
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator	Drug: Trexima Sumatriptan + Naproxen Sodium Drug: Butalbital-containing Combination Medications (BCM) butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet]) Drug: butalbital butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet])

Detailed Description:

Study TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMA™ (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 (Study 1 of 2)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females aged 18 to 65 years. If female, using contraception if sexually active and not breastfeeding. If using oral contraceptives, the subjects should be on a stable regimen of oral contraceptives (> 2 months).
Subjects must have an active prescription for a butalbital-containing medication (BCM), must be currently using it as their primary treatment of migraine, and must have used the BCM to treat at least one migraine within the past 30 days.
Subjects must have migraine with or without aura (2004 ICHD-II criteria) and must have had at least 2 attacks per month meeting these criteria in three months prior to screening.
Subjects must be able to understand how to complete the cognitive assessments and all other questionnaires programmed in an electronic diary (eDiary).
Subject must be able to read English or Spanish and comprehend protocol requirements
Subject is willing and able to provide written informed consent.

Exclusion Criteria:

Subject has >8 migraines or 15 headache days per month in total
Subject has taken >350mg/day of butalbital and/or other barbiturates on average over the 30 days prior to screening.
Subject has a history of heart disease, abdominal perforation or surgery, abdominal ulcer in last 6 months, abdominal bleeding in last 12 months, bowel disease, and any bleeding disorder
Subject has allergy, intolerance, or contraindication to the use of any triptan, NSAID, aspirin, barbituates, or acetaminophen (including all sumatriptan and naproxen preparations), has porphyria or has nasal polyps and asthma.
Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a migraine or prophylactic medication that is not stabilized (i.e. change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
Subject has a recent history of regular use of opioids or barbiturates, other than Butalbital, for the treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months
Subject has participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599157

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 73 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, Pharm D

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TRX109013
Study First Received:	January 10, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00599157
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Migraine
Butalbital-containing Combination Medication (BCM)
Sumatriptan succinate
Naproxen sodium
TREXIMA

Study placed in the following topic categories:

Sumatriptan
Caffeine citrate
Naproxen
Migraine Disorders
Headache
Central Nervous System Diseases

Caffeine
Headache Disorders, Primary
Brain Diseases
Serotonin
Acetaminophen
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Gout Suppressants
Pharmacologic Actions

Serotonin Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009