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Completed

NCT Number: NCT00712725

MK3207 for Treatment of Acute Migraines (3207-005)

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK3207- 2.5 mg

Drug

Arm 1: MK3207 2.5 mg taken after migraine onset.

Other names: MK3207

MK3207- 5 mg

Drug

Arm 2: MK3207 5 mg taken after migraine onset.

Other names: MK3207

MK3207- 10 mg

Drug

Arm 3: MK3207 10 mg taken after migraine onset.

Other names: MK3207

MK3207- 20 mg

Drug

Arm 4: MK3207 20 mg taken after migraine onset.

Other names: MK3207

MK3207- 50 mg

Drug

Arm 5: MK3207 50 mg taken after migraine onset.

Other names: MK3207

MK3207- 100 mg

Drug

Arm 6: MK3207 100 mg taken after migraine onset.

Other names: MK3207

Comparator: Placebo (Unspecified)

Drug

Placebo taken after migraine onset.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. Absence of Photophobia

    Time frame: 2 hours postdose

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

  3. Absence of Phonophobia

    Time frame: 2 hours postdose

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

  4. Absence of Nausea

    Time frame: 2 hours postdose

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

  5. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 10, 2008
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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