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TREXIMET

Phase 3

Migraine Disorders | Small molecule | Neurology |GSK plc|Last Updated: Dec 29, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment375
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00573170TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in AdultsPHASE3 COMPLETED 375 — — Feb 1, 2008Aug 1, 2009Dec 29, 2010107 United States
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Study Endpoints
Primary Endpoints
Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose
From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).

SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours.

Secondary Endpoints
Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose
At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Number of Participants Using Rescue Medication Within 48 Hours Post Dose
From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1)
From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TPBOTHERTREXIMET® (Attack 1), placebo (Attack 2), BCM (Attack 3)
TBPOTHERTREXIMET® (Attack 1), BCM (Attack 2), placebo (Attack 3)
BTPOTHERBCM (Attack 1), TREXIMET® (Attack 2), placebo (Attack 3)
BPTOTHERBCM (Attack 1), placebo (Attack 2), TREXIMET® (Attack 3)
PTBOTHERplacebo (Attack 1), TREXIMET® (Attack 2), BCM (Attack 3)
PBTOTHERplacebo (Attack 1), BCM (Attack 2), TREXIMET® (Attack 3)
Interventions
NameTypeDescription
TREXIMET®DRUGSumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg)
Butalbital-containing Combination Medications (BCM)DRUGbutalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\]
placeboDRUGplacebo
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites107

Inclusion Criteria: * Males and females aged 18 to 65 years. Female subjects are eligible for participation if they are either of non-childbearing potential (not capable of becoming pregnant) OR of childbearing potential having a negative urine pregnancy test at screening, and using contraception i...

Countries:United States
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