NCT00712725

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
676

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 22, 2010

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

July 8, 2008

Results QC Date

October 22, 2010

Last Update Submit

January 23, 2015

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Pain Freedom (PF)

    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

    2 hours postdose

Secondary Outcomes (5)

  • Pain Relief (PR)

    2 hours postdose

  • Absence of Photophobia

    2 hours postdose

  • Absence of Phonophobia

    2 hours postdose

  • Absence of Nausea

    2 hours postdose

  • Sustained Pain Freedom (SPF)

    2-24 hours postdose

Study Arms (7)

1

EXPERIMENTAL

MK3207- 2.5 mg

Drug: MK3207- 2.5 mg

2

EXPERIMENTAL

MK3207- 5 mg

Drug: MK3207- 5 mg

3

EXPERIMENTAL

MK3207- 10 mg

Drug: MK3207- 10 mg

4

EXPERIMENTAL

MK3207- 20 mg

Drug: MK3207- 20 mg

5

EXPERIMENTAL

MK3207- 50 mg

Drug: MK3207- 50 mg

6

EXPERIMENTAL

MK3207- 100 mg

Drug: MK3207- 100 mg

7

PLACEBO COMPARATOR

Placebo

Drug: Comparator: placebo (unspecified)

Interventions

MK3207- 2.5 mgDRUG

Arm 1: MK3207 2.5 mg taken after migraine onset.

Also known as: MK3207
1
MK3207- 5 mgDRUG

Arm 2: MK3207 5 mg taken after migraine onset.

Also known as: MK3207
2
MK3207- 10 mgDRUG

Arm 3: MK3207 10 mg taken after migraine onset.

Also known as: MK3207
3
MK3207- 20 mgDRUG

Arm 4: MK3207 20 mg taken after migraine onset.

Also known as: MK3207
4
MK3207- 50 mgDRUG

Arm 5: MK3207 50 mg taken after migraine onset.

Also known as: MK3207
5
MK3207- 100 mgDRUG

Arm 6: MK3207 100 mg taken after migraine onset.

Also known as: MK3207
6
Comparator: placebo (unspecified)DRUG

Placebo taken after migraine onset.

7

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and Women from 18 to 65 years of age
  • + 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21383045RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

2-(8-(3,5-difluorophenyl)-10-oxo-6,9-diazaspiro(4.5)dec-9-yl)-N-(2'-oxo-1,1',2',3-tetrahydrospiro(indene-2,3'-pyrrolo(2,3-b)pyridin)-5-yl)acetamide

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 10, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 2, 2015

Results First Posted

November 22, 2010

Record last verified: 2015-01