Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

NCT ID: NCT00516737

Last Updated: 2024-04-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-03

Study Completion Date

2008-04-08

Brief Summary

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The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute 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

Study Groups

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1

Active Drug

Group Type EXPERIMENTAL

Comparator: rizatriptan benzoate

Intervention Type DRUG

Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack

2

Matching Pbo Comparator

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Matching placebo; one dose, treatment of a single migraine attack

Interventions

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Comparator: rizatriptan benzoate

Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack

Intervention Type DRUG

Comparator: Placebo

Matching placebo; one dose, treatment of a single migraine attack

Intervention Type DRUG

Other Intervention Names

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MK0462

Eligibility Criteria

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Inclusion Criteria

* Greater than one year history of migraine
* Attacks typically mild when they begin and progress to moderate or severe
* Experience 1-4 migraine attacks per month

Exclusion Criteria

* More than 15 headache days per month
* Heart disease
* Uncontrolled high blood pressure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

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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Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x.

Reference Type BACKGROUND
PMID: 19472447 (View on PubMed)

Other Identifiers

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2007_547

Identifier Type: -

Identifier Source: secondary_id

0462-081

Identifier Type: -

Identifier Source: org_study_id

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