Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)

NCT ID: NCT00432237

Last Updated: 2015-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1703 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for 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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MK0974 50 mg

MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack

Group Type EXPERIMENTAL

MK0974 50 mg

Intervention Type DRUG

MK0974 150 mg

MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack

Group Type EXPERIMENTAL

MK0974 150 mg

Intervention Type DRUG

MK0974 300 mg

MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack

Group Type EXPERIMENTAL

MK0974 300 mg

Intervention Type DRUG

Placebo

Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.

Interventions

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MK0974 50 mg

Intervention Type DRUG

MK0974 150 mg

Intervention Type DRUG

MK0974 300 mg

Intervention Type DRUG

Comparator: Placebo

MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.

Intervention Type DRUG

Other Intervention Names

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MK0974 MK0974 MK0974

Eligibility Criteria

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Inclusion Criteria

* Patient has at least 1 year history of migraine (with or without aura)
* Females of childbearing years must use acceptable contraception throughout trial

Exclusion Criteria

* Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
* Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular 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
Minimum Eligible Age

18 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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Connor KM, Shapiro RE, Diener HC, Lucas S, Kost J, Fan X, Fei K, Assaid C, Lines C, Ho TW. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology. 2009 Sep 22;73(12):970-7. doi: 10.1212/WNL.0b013e3181b87942.

Reference Type RESULT
PMID: 19770473 (View on PubMed)

Other Identifiers

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2006_526

Identifier Type: -

Identifier Source: secondary_id

0974-016

Identifier Type: -

Identifier Source: org_study_id

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