MK0974 Pivotal Study 1 - WW (With Active Comparator) - Tabular View

Tracking Information

First Received Date ^ICMJE

February 28, 2007

Last Updated Date

January 30, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pain Freedom at 2 hours post-dose, Pain Relief at 2 hours post-dose, Absence of photophobia, phonophobia, and nausea at 2 hrs post-dose

Original Primary Outcome Measures ^ICMJE

Pain Freedom at 2 hours postdose, Pain Relief at 2 hours postdose, Absence of photophobia, phonophobia, and nausea at 2 hrs postdose

Change History

Complete list of historical versions of study NCT00442936 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sustained Pain-Freedom from 2 to 24 hours after study drug administration, Total Migraine Freedom at 2 hours post-dose, Total Migraine Freedom from 2 to 24 hours post-dose

Original Secondary Outcome Measures ^ICMJE

Sustained Pain-Freedom from 2 to 24 hours after study drug administration, Total Migraine Freedom at 2 hours postdose, Total Migraine Freedom from 2 to 24 hours postdose

Descriptive Information

Brief Title ^ICMJE

MK0974 Pivotal Study 1 - WW (With Active Comparator)

Official Title ^ICMJE

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Response to a Single Treatment With Oral MK0974 With Placebo and Comparator in Subjects With Moderate to Severe Acute Migraine With or Without Aura

Brief Summary

The purpose of this study is to investigate the efficacy and safety of MK0974 compared to an approved medication for acute migraine.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: MK0974 / Duration of Treatment: 1 Day
Drug: Comparator: zolmitriptan / Duration of Treatment: 1 Day
Drug: Comparator: placebo (unspecified) / Duration of Treatment: 1 Day

Study Arms / Comparison Groups

Publications *

Ho TW, Ferrari MD, Dodick DW, Galet V, Kost J, Fan X, Leibensperger H, Froman S, Assaid C, Lines C, Koppen H, Winner PK. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial. Lancet. 2008 Dec 20;372(9656):2115-23. Epub 2008 Nov 25.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1800

Completion Date

October 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient has at least 1 year history of migraine (with or without aura)
Females of child bearing potential must use acceptable contraception throughout trial

Exclusion Criteria:

Patient is pregnant/breast-feeding (or is a female expecting to conceive during study period)
Patient has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or HIV disease
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
Patient has a history of cancer within the last 5 years

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

Administrative Information

NCT ID ^ICMJE

NCT00442936

Responsible Party

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

Study ID Numbers ^ICMJE

2006_525, MK0974-011

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

January 2009

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