MK3207 for Treatment of Acute Migraines (3207-005)

Merck Sharp & Dohme LLC676 enrolled

Overview

The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of MK3207 in the treatment of acute migraine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

676

Conditions

Migraine

Interventions

MK3207- 2.5 mgDRUG

Arm 1: MK3207 2.5 mg taken after migraine onset.

MK3207- 5 mgDRUG

Arm 2: MK3207 5 mg taken after migraine onset.

MK3207- 10 mgDRUG

Arm 3: MK3207 10 mg taken after migraine onset.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Pregnant or breast-feeding, or planning to become pregnant in next 6 months * Cannot distinguish migraine attacks from tension type headaches * Migraines are mild or resolve without medication in less than 2 hours * More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months * Basilar type or hemiplegic migraine headaches * More than 50 years old when migraines began * History of cardiovascular disorder within last 6 months

Outcomes

Primary Outcomes

Pain Freedom (PF)

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

Time frame: 2 hours postdose

Secondary Outcomes

Pain Relief (PR)

Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 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

Time frame: 2 hours postdose

Absence of Photophobia

Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.

Time frame: 2 hours postdose

Absence of Phonophobia

Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.

Time frame: 2 hours postdose

Absence of Nausea

Absence of nausea at 2 hours postdose as recorded by patient on paper diary.

Time frame: 2 hours postdose

Sustained Pain Freedom (SPF)

Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.

Time frame: 2-24 hours postdose

Data from ClinicalTrials.gov

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