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MK3207

Phase 2

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

MK3207 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Oct 2007

MK3207 target and mechanism

Molecular targetCALCRL
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment698

FDA Designations

No designations recorded

MK3207 clinical trials

MK3207 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00712725MK3207 for Treatment of Acute Migraines (3207-005)Migraine
COMPLETED676 Analytics
PHASE2COMPLETED
MK3207 for Treatment of Acute Migraines (3207-005)
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Study Endpoints

Primary Endpoints

Pain Freedom (PF)
2 hours postdose

Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose. Rating of Headache Severity (Scale from Grade 0 to 3): * Grade 0: No pain * Grade 1: Mild pain * Grade 2: Moderate pain * Grade 3: Severe pain

Safety in migraine patients
12 Weeks

Secondary Endpoints

Pain Relief (PR)
2 hours postdose
Absence of Photophobia
2 hours postdose
Absence of Phonophobia
2 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMK3207- 2.5 mg
2EXPERIMENTALMK3207- 5 mg
3EXPERIMENTALMK3207- 10 mg
4EXPERIMENTALMK3207- 20 mg
5EXPERIMENTALMK3207- 50 mg
6EXPERIMENTALMK3207- 100 mg
7PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
MK3207- 2.5 mgDRUGArm 1: MK3207 2.5 mg taken after migraine onset.
MK3207- 5 mgDRUGArm 2: MK3207 5 mg taken after migraine onset.
MK3207- 10 mgDRUGArm 3: MK3207 10 mg taken after migraine onset.
MK3207- 20 mgDRUGArm 4: MK3207 20 mg taken after migraine onset.
MK3207- 50 mgDRUGArm 5: MK3207 50 mg taken after migraine onset.
MK3207- 100 mgDRUGArm 6: MK3207 100 mg taken after migraine onset.
Comparator: placebo (unspecified)DRUGPlacebo taken after migraine onset.
MK3207DRUGM3207 (20 mg); patients will be administered a single dose of 100 mg of MK3207 (i.e., 5 x20-mg tablets).
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Men and Women from 18 to 65 years of age * 1+ year history of migraine that typically last from 4 to 72 hours if untreated * Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months * Not pregnant or planning to become pregnant in next 6 months Exclu...

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Competitive Landscape -Migraine 43 trials

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Frequently asked questions about MK3207

What is MK3207 used for?

MK3207 is being developed for the treatment of migraine and migraine disorders. It is a small molecule under study for acute migraine treatment, and the clinical program has focused on patients 18 years and older with migraine. It remains investigational and is not an approved therapy.

What does MK3207 target?

MK3207 targets CALCRL, the calcitonin receptor-like receptor, and acts as an antagonist. By blocking CALCRL, the drug is designed to interfere with CGRP-family signaling implicated in migraine. This mechanism places MK3207 in the same target class as other small molecule migraine therapies aimed at CGRP pathway receptors.

Who is developing MK3207?

MK3207 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck conducted the clinical studies of the compound in migraine, including a Phase 2 trial and an earlier Phase 1 study. The asset is an internal Merck program rather than a partnered or out-licensed candidate.

What phase is MK3207 in?

MK3207 is in Phase 2 development. The furthest advanced study is a completed Phase 2 trial in acute migraine, and the program has not progressed beyond that stage. MK3207 is investigational and has not been approved by the FDA for any indication.

What clinical trials is MK3207 in?

MK3207 has been studied in two completed trials. NCT00712725 was a Phase 2 trial of MK3207 for treatment of acute migraines that enrolled 676 patients. NCT00548353 was a Phase 1 study of gastric delay in migraine patients that enrolled 22 participants. Both studies are listed as completed.