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MK3207 for Treatment of Acute Migraines (3207-005)

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ClinicalTrials.gov Identifier: NCT00712725
Recruitment Status : Completed
First Posted : July 10, 2008
Results First Posted : November 22, 2010
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 676 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712725


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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00712725     History of Changes
Other Study ID Numbers: 3207-005
2008_536
First Posted: July 10, 2008    Key Record Dates
Results First Posted: November 22, 2010
Last Update Posted: February 2, 2015
Last Verified: January 2015

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