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

July 8, 2008
April 29, 2014
July 2008
January 2009   (final data collection date for primary outcome measure)
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
Effectiveness of MK3207 in the treatment of acute migraine as measured by pain freedom at 2 hours post dose. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00712725 on ClinicalTrials.gov Archive Site
  • 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.
To evaluate the safety and tolerability of various doses of MK3207 in the treatment of acute migraine [ Time Frame: 2 hours post dose ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
MK3207 for Treatment of Acute Migraines (3207-005)
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine
  • Drug: MK3207- 2.5 mg
    Arm 1: MK3207 2.5 mg taken after migraine onset.
    Other Name: MK3207
  • Drug: MK3207- 5 mg
    Arm 2: MK3207 5 mg taken after migraine onset.
    Other Name: MK3207
  • Drug: MK3207- 10 mg
    Arm 3: MK3207 10 mg taken after migraine onset.
    Other Name: MK3207
  • Drug: MK3207- 20 mg
    Arm 4: MK3207 20 mg taken after migraine onset.
    Other Name: MK3207
  • Drug: MK3207- 50 mg
    Arm 5: MK3207 50 mg taken after migraine onset.
    Other Name: MK3207
  • Drug: MK3207- 100 mg
    Arm 6: MK3207 100 mg taken after migraine onset.
    Other Name: MK3207
  • Drug: Comparator: placebo (unspecified)
    Placebo taken after migraine onset.
  • Experimental: 1
    MK3207- 2.5 mg
    Intervention: Drug: MK3207- 2.5 mg
  • Experimental: 2
    MK3207- 5 mg
    Intervention: Drug: MK3207- 5 mg
  • Experimental: 3
    MK3207- 10 mg
    Intervention: Drug: MK3207- 10 mg
  • Experimental: 4
    MK3207- 20 mg
    Intervention: Drug: MK3207- 20 mg
  • Experimental: 5
    MK3207- 50 mg
    Intervention: Drug: MK3207- 50 mg
  • Experimental: 6
    MK3207- 100 mg
    Intervention: Drug: MK3207- 100 mg
  • Placebo Comparator: 7
    Placebo
    Intervention: Drug: Comparator: placebo (unspecified)
Hewitt DJ, Aurora SK, Dodick DW, Goadsby PJ, Ge YJ, Bachman R, Taraborelli D, Fan X, Assaid C, Lines C, Ho TW. Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia. 2011 Apr;31(6):712-22. doi: 10.1177/0333102411398399. Epub 2011 Mar 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
676
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00712725
3207-005, 2008_536
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP