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acetominophen

Phase 2

Migraine | Small molecule | Neurology |Merck & Company, Inc.|Last Updated: Oct 22, 2018

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment683
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00758836A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)PHASE2 COMPLETED 683Dec 3, 2008Aug 24, 2009Oct 22, 2018 -
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Study Endpoints
Primary Endpoints
Percentage of Participants With Pain Freedom at Two Hours Post-dose
2 hours post-dose

Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).

Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)
Up to 48 hours post-dose

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)
Up to 14 days post-dose

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Secondary Endpoints
Percentage of Participants With Pain Relief at 2 Hours Post-dose.
2 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants take two placebo tablets and two placebo capsules, orally, at onset of migraine
Telcagepant 280 mg +Ibuprofen 400 mgEXPERIMENTALParticipants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
Telcagepant 280 mg +APAP 1000 mgEXPERIMENTALParticipants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
Telcagepant 280 mgPLACEBO_COMPARATORParticipants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
Interventions
NameTypeDescription
placeboDRUG -
ibuprofenDRUG -
acetominophenDRUG -
telcagepantDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Must be 18 years of age or older * History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study * Willing to stay awake for at least 2 hours after taking study drug * Able to...

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