MK3207 for Treatment of Acute Migraines (3207-005)

January 23, 2015 updated by: Merck Sharp & Dohme LLC

A Phase IIb, Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-finding Study of MK3207 in the Treatment of Acute Migraine

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

676

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
MK3207- 2.5 mg
Drug: MK3207- 2.5 mg
Arm 1: MK3207 2.5 mg taken after migraine onset.
Other Names:
  • MK3207
EXPERIMENTAL: 2
MK3207- 5 mg
Drug: MK3207- 5 mg
Arm 2: MK3207 5 mg taken after migraine onset.
Other Names:
  • MK3207
EXPERIMENTAL: 3
MK3207- 10 mg
Drug: MK3207- 10 mg
Arm 3: MK3207 10 mg taken after migraine onset.
Other Names:
  • MK3207
EXPERIMENTAL: 4
MK3207- 20 mg
Drug: MK3207- 20 mg
Arm 4: MK3207 20 mg taken after migraine onset.
Other Names:
  • MK3207
EXPERIMENTAL: 5
MK3207- 50 mg
Drug: MK3207- 50 mg
Arm 5: MK3207 50 mg taken after migraine onset.
Other Names:
  • MK3207
EXPERIMENTAL: 6
MK3207- 100 mg
Drug: MK3207- 100 mg
Arm 6: MK3207 100 mg taken after migraine onset.
Other Names:
  • MK3207
PLACEBO_COMPARATOR: 7
Placebo
Drug: Comparator: placebo (unspecified)
Placebo taken after migraine onset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Freedom (PF)
Time Frame: 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
2 hours postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relief (PR)
Time Frame: 2 hours postdose

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
2 hours postdose
Absence of Photophobia
Time Frame: 2 hours postdose
Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.
2 hours postdose
Absence of Phonophobia
Time Frame: 2 hours postdose
Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.
2 hours postdose
Absence of Nausea
Time Frame: 2 hours postdose
Absence of nausea at 2 hours postdose as recorded by patient on paper diary.
2 hours postdose
Sustained Pain Freedom (SPF)
Time Frame: 2-24 hours postdose
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.
2-24 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (ESTIMATE)

July 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 23, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3207-005
  • 2008_536

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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