Acute Treatment of Multiple Migraines With or Without Aura in Adults

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00483704

First received: May 15, 2007

Last updated: September 3, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 15, 2007

Last Updated Date

September 3, 2009

Start Date ^ICMJE

August 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Compare the effectiveness, consistency, and safety of two doses of MK0974 with placebo in patients with acute migraine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Evaluate the efficacy and safety of MK0974 compared to placebo in the treatment of acute migraine and evaluate consistency of efficacy and safety of MK0974 across multiple migraine attacks

Change History

Complete list of historical versions of study NCT00483704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sustained pain freedom and total migraine freedom [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Measure the efficacy of MK0974 (300 mg & 150 mg) compared to placebo in the treatment of acute migraine using sustained pain freedom and total migraine freedom & examine the dose-response of MK0974 for pain freedom and relief at 2 hrs across all doses

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Acute Treatment of Multiple Migraines With or Without Aura in Adults

Official Title ^ICMJE

A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK0974 With Placebo for the Acute Treatment of Migraine With or Without Aura

Brief Summary

The purpose of the study is to assess the safety and efficacy of MK0974 in acute treatment of multiple migraine attacks with or without aura.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Migraines

Intervention ^ICMJE

Drug: Comparator: MK0974
Patients will have up to 6 months to treat 4 migraine attacks. Arm 1: All 4 migraine attacks will be treated with MK0974 140 mg tablets Arm 2: All 4 migraine attacks will be treated with MK0974 280 mg tablets. All patients will take study drug at time of migraine onset.

Other Name: MK0974
Drug: Comparator: Placebo
All patients will have 6 months to treat 4 migraine attacks. Arms 3 and 4: 3 migraine attacks will be treated with placebo and 1 migraine attack will be treated with MK0974 140 mg tablets. All patients will take study drug at time of migraine onset.

Study Arm (s)

Experimental: 1
MK0974

Intervention: Drug: Comparator: MK0974
Experimental: 2
MK0974

Intervention: Drug: Comparator: MK0974
Placebo Comparator: 3
Placebo Comparator

Intervention: Drug: Comparator: Placebo
Placebo Comparator: 4
Placebo Comparator

Intervention: Drug: Comparator: Placebo

Publications *

Ho AP, Dahlöf CG, Silberstein SD, Saper JR, Ashina M, Kost JT, Froman S, Leibensperger H, Lines CR, Ho TW. Randomized, controlled trial of telcagepant over four migraine attacks. Cephalalgia. 2010 Dec;30(12):1443-57. Epub 2010 Jun 8.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1800

Completion Date

April 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient has had a history of migraines within the past year
Patient has had 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 - 72 if untreated
Patients must use acceptable contraception throughout the study
Patient is able to complete the study questionnaire(s) and paper diary
Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

Exclusion Criteria:

Patient is pregnant or breast-feeding or is expecting to become pregnant during the study
Patient has difficulty distinguishing his/her migraine attacks from tension or interval headaches
Patient has a history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
Patient was greater than 50 years old at the age of migraine onset
Patient has previously taken MK0974

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00483704

Other Study ID Numbers ^ICMJE

2007_546, MK0974-031

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2009

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

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