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: April 29, 2014
Last verified: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 29, 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 August 21, 2014