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acetominophen

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment683

FDA Designations

No designations recorded

Clinical trial landscape

acetominophen · 1 trial · 1 indication

Phase 2 1
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)Migraine
COMPLETED683 Analytics
PHASE2COMPLETED
A 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)
MigraineUnlock trial analytics

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 to 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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Competitive Landscape -Migraine 30 trials

Frequently asked questions about acetominophen

What is acetominophen used for in migraine?

Acetominophen is a small molecule being studied for the treatment of migraine with or without aura. In clinical research, it has been evaluated as a co-administered therapy alongside other migraine medications to assess its safety and effectiveness in patients experiencing migraines.

Who makes acetominophen?

Acetominophen is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research to evaluate the drug's potential in treating migraine with or without aura.

What phase is acetominophen in?

Acetominophen is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under evaluation for its safety and effectiveness in migraine treatment.

What clinical trials is acetominophen in?

Acetominophen has been studied in one completed Phase 2 clinical trial, identified as NCT00758836. This randomized, double-blind, placebo-controlled study enrolled 683 participants aged 18 years and older to evaluate the safety and effectiveness of acetominophen co-administered with other migraine medications.

Is acetominophen the same as telcagepant?

Acetominophen is not the same as telcagepant. The clinical trial NCT00758836 evaluated telcagepant (MK-0974) co-administered with either ibuprofen or acetominophen. Acetominophen was used as a co-administered medication in the study, not as the primary investigational drug.