MK3207 for Treatment of Acute Migraines (3207-005)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00712725
First received: July 8, 2008
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Migraine
Drug: MK3207- 2.5 mg
Drug: MK3207- 5 mg
Drug: MK3207- 10 mg
Drug: MK3207- 20 mg
Drug: MK3207- 50 mg
Drug: MK3207- 100 mg
Drug: Comparator: placebo (unspecified)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb, Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-finding Study of MK3207 in the Treatment of Acute Migraine

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Pain Freedom (PF) [ Time Frame: 2 hours postdose ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Pain Relief (PR) [ Time Frame: 2 hours postdose ] [ Designated as safety issue: Yes ]

    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

  • Absence of Photophobia [ Time Frame: 2 hours postdose ] [ Designated as safety issue: Yes ]
    Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.

  • Absence of Phonophobia [ Time Frame: 2 hours postdose ] [ Designated as safety issue: Yes ]
    Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.

  • Absence of Nausea [ Time Frame: 2 hours postdose ] [ Designated as safety issue: Yes ]
    Absence of nausea at 2 hours postdose as recorded by patient on paper diary.

  • Sustained Pain Freedom (SPF) [ Time Frame: 2-24 hours postdose ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 676
Study Start Date: July 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK3207- 2.5 mg
Drug: MK3207- 2.5 mg
Arm 1: MK3207 2.5 mg taken after migraine onset.
Other Name: MK3207
Experimental: 2
MK3207- 5 mg
Drug: MK3207- 5 mg
Arm 2: MK3207 5 mg taken after migraine onset.
Other Name: MK3207
Experimental: 3
MK3207- 10 mg
Drug: MK3207- 10 mg
Arm 3: MK3207 10 mg taken after migraine onset.
Other Name: MK3207
Experimental: 4
MK3207- 20 mg
Drug: MK3207- 20 mg
Arm 4: MK3207 20 mg taken after migraine onset.
Other Name: MK3207
Experimental: 5
MK3207- 50 mg
Drug: MK3207- 50 mg
Arm 5: MK3207 50 mg taken after migraine onset.
Other Name: MK3207
Experimental: 6
MK3207- 100 mg
Drug: MK3207- 100 mg
Arm 6: MK3207 100 mg taken after migraine onset.
Other Name: MK3207
Placebo Comparator: 7
Placebo
Drug: Comparator: placebo (unspecified)
Placebo taken after migraine onset.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712725

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00712725     History of Changes
Other Study ID Numbers: 3207-005, 2008_536
Study First Received: July 8, 2008
Results First Received: October 22, 2010
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014