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MK0974

Phase 3

Migraine | Small molecule | Neurology |Merck & Company, Inc.|Trials Updated: Nov 2, 2015

MK0974 development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Oct 2005

MK0974 target and mechanism

ModalitySmall molecule

Also known as MK0974 tablet

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials3
Total Enrollment2,173

FDA Designations

No designations recorded

MK0974 clinical trials

MK0974 · 3 trials · 1 indication

Phase 3 1Phase 2 1Phase 1 1
NCT00432237Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)Migraine
COMPLETED1,703 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)
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Study Endpoints

Primary Endpoints

Number of Patients Reporting Pain Freedom at 2 Hours Postdose
2 hours post dose

Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

Number of Patients Reporting Pain Relief at 2 Hours Post Dose
2 hours post dose

Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose
2 hours post dose

Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.

Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose
2 hours post dose

Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.

Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose
2 hours post dose

Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.

Pain Relief at 2 Hours
2 hours post dose

Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.

Area under the curve (AUC(0 to infinity)) following single dose administration of MK0974 tablet formulation and MK0974 liquid filled capsule formulation
Through 48 Hours Post Dose
Peak plasma concentration (Cmax) following single dose administration of MK0974 tablet formulation and MK0974 liquid filled capsule formulation
Through 48 Hours Post Dose

Secondary Endpoints

Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose
2 to 24 hours postdose
Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose
2 to 24 hours postdose
Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose
2 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK0974 50 mgEXPERIMENTALMK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mgEXPERIMENTALMK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mgEXPERIMENTALMK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
PlaceboPLACEBO_COMPARATORPlacebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
MK0974 25 mgEXPERIMENTALMK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 100 mgEXPERIMENTALMK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 200 mgEXPERIMENTALMK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 400 mgEXPERIMENTALMK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 600 mgEXPERIMENTALMK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Rizatriptan 10 mgACTIVE_COMPARATORRizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1EXPERIMENTALMK0974 Tablet
2ACTIVE_COMPARATORMK0974 Liquid filled capsule

Interventions

NameTypeDescription
MK0974 50 mgDRUG -
MK0974 150 mgDRUG -
MK0974 300 mgDRUG -
Comparator: PlaceboDRUGMK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.
MK0974DRUGMK0974 25 mg; one orally-administered dose
RizatriptanDRUGRizatriptan 10 mg; one orally-administered dose
MK0974 tabletDRUGMK0974 280 mg tablet in one of two treatment periods
Comparator: MK0974 liquid filled capsuleDRUGMK0974 300 mg liquid filled capsule in one of two treatment periods
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient has at least 1 year history of migraine (with or without aura) * Females of childbearing years must use acceptable contraception throughout trial Exclusion Criteria: * Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period) *...

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Competitive Landscape -Migraine 43 trials

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Frequently asked questions about MK0974

What is MK0974 used for?

MK0974 is an investigational small molecule being studied for the treatment of migraine. It has been evaluated in clinical trials for acute migraine, meaning treatment taken during a migraine attack. It is in Phase 3 development and is not described as approved for any indication.

Who makes MK0974?

MK0974 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the clinical trial program for the drug, including Phase 1, Phase 2, and Phase 3 studies in migraine.

What phase is MK0974 in?

MK0974 is in Phase 3 development. Its clinical program includes a completed Phase 3 safety and efficacy study, a completed Phase 2 dose-finding study, and a completed Phase 1 bioequivalence study. All three trials are listed as completed, with no active trials.

What clinical trials is MK0974 in?

MK0974 has been studied in three completed trials: NCT00432237, a Phase 3 safety and efficacy study in acute migraine with 1,703 participants; NCT00246337, a Phase 2 dose-finding study in acute migraine with 420 participants; and NCT00966030, a Phase 1 bioequivalence study comparing tablet and liquid-filled capsule forms with 50 healthy volunteers.

How many patients were enrolled in MK0974 trials?

Across the three completed MK0974 trials, 2,173 participants were enrolled in total. The largest was the Phase 3 study NCT00432237 with 1,703 participants, followed by the Phase 2 dose-finding study NCT00246337 with 420 participants and the Phase 1 bioequivalence study NCT00966030 with 50 healthy volunteers.