MK3207 for Treatment of Acute Migraines (3207-005)

NCT ID: NCT00712725

Last Updated: 2015-02-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

676 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-01-31

Brief Summary

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

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

MK3207- 2.5 mg

Group Type EXPERIMENTAL

MK3207- 2.5 mg

Intervention Type DRUG

Arm 1: MK3207 2.5 mg taken after migraine onset.

2

MK3207- 5 mg

Group Type EXPERIMENTAL

MK3207- 5 mg

Intervention Type DRUG

Arm 2: MK3207 5 mg taken after migraine onset.

3

MK3207- 10 mg

Group Type EXPERIMENTAL

MK3207- 10 mg

Intervention Type DRUG

Arm 3: MK3207 10 mg taken after migraine onset.

4

MK3207- 20 mg

Group Type EXPERIMENTAL

MK3207- 20 mg

Intervention Type DRUG

Arm 4: MK3207 20 mg taken after migraine onset.

5

MK3207- 50 mg

Group Type EXPERIMENTAL

MK3207- 50 mg

Intervention Type DRUG

Arm 5: MK3207 50 mg taken after migraine onset.

6

MK3207- 100 mg

Group Type EXPERIMENTAL

MK3207- 100 mg

Intervention Type DRUG

Arm 6: MK3207 100 mg taken after migraine onset.

7

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: placebo (unspecified)

Intervention Type DRUG

Placebo taken after migraine onset.

Interventions

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MK3207- 2.5 mg

Arm 1: MK3207 2.5 mg taken after migraine onset.

Intervention Type DRUG

MK3207- 5 mg

Arm 2: MK3207 5 mg taken after migraine onset.

Intervention Type DRUG

MK3207- 10 mg

Arm 3: MK3207 10 mg taken after migraine onset.

Intervention Type DRUG

MK3207- 20 mg

Arm 4: MK3207 20 mg taken after migraine onset.

Intervention Type DRUG

MK3207- 50 mg

Arm 5: MK3207 50 mg taken after migraine onset.

Intervention Type DRUG

MK3207- 100 mg

Arm 6: MK3207 100 mg taken after migraine onset.

Intervention Type DRUG

Comparator: placebo (unspecified)

Placebo taken after migraine onset.

Intervention Type DRUG

Other Intervention Names

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MK3207 MK3207 MK3207 MK3207 MK3207 MK3207

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 21383045 (View on PubMed)

Other Identifiers

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2008_536

Identifier Type: -

Identifier Source: secondary_id

3207-005

Identifier Type: -

Identifier Source: org_study_id

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