Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-072)

NCT ID: NCT00111722

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-27

Study Completion Date

2006-02-23

Brief Summary

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The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.

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

Interventions

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MK0462, rizatriptan benzoate / Duration of Treatment -1day

Intervention Type DRUG

Comparator: placebo / Duration of Treatment - 1 day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female patient at least 18 years old
* Patient has menses approximately monthly
* Patient has at least a 6 month history of migraine and at least a 6 month history of menstrual migraine

Exclusion Criteria

* Pregnant and/or nursing mother
* Cardiovascular disease
* Uncontrolled hypertension
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

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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Mannix LK, Loder E, Nett R, Mueller L, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007 May;27(5):414-21. doi: 10.1111/j.1468-2982.2007.01313.x.

Reference Type BACKGROUND
PMID: 17448179 (View on PubMed)

Nett R, Mannix LK, Mueller L, Rodgers A, Hustad CM, Skobieranda F, Ramsey KE. Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. Headache. 2008 Sep;48(8):1194-201. doi: 10.1111/j.1526-4610.2008.01093.x. Epub 2008 Apr 14.

Reference Type BACKGROUND
PMID: 18422606 (View on PubMed)

Other Identifiers

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2005_025

Identifier Type: -

Identifier Source: secondary_id

0462-072

Identifier Type: -

Identifier Source: org_study_id

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