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COMPLETEDPHASE4

Rizatriptan 10 MG RPD in the Treatment of Acute Migraine

A Study of the Efficacy and Safety of Rizatriptan 10 mg RPD in the Treatment of Acute Migraine in Patients With Non Satisfactory Response to Previous Pharmacologic Treatment

NCT01057160•Universität Duisburg-Essen

View on ClinicalTrials.gov

Summary

This is a multicentre, open label, prospective, randomized, two-attack study with active comparator in patients reporting inadequate response to analgesics and/or triptans to examine the efficacy of Rizatriptan 10 mg RPD in this group of patients.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient's signature on the informed consent document \[each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form\].
•Have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.
•At screening at least two migraine attacks per month and no more than ten during the last three months prior to inclusion.
•At screening a stable dose of prophylactic medication (including no prophylactic treatment) for at least two months and no change of prophylactic medication during active trial period.

Exclusion Criteria

•Contraindication to triptans or Rizatriptan according to medical information sheet.
•Patient has a history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease. Patient has uncontrolled hypertension. Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to Rizatriptan or any of its inactive ingredients.
•History of treatment failure for at least one triptan for the treatment of acute migraine attacks.
•Any other headache, except tension type headache on 5 or less days a month within three months prior to screening.
•A history of drug induced headache, medication overuse headache or any other addiction.
•Any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial.
•Females of childbearing potential not using reliable means of birth control, pregnant or lactating females or expected/ planned pregnancy.
•Participation (planned or current) in any investigational drug or device trial within the previous 30 days prior to screening visit.
•Inability to understand the trial procedures, and thus inability to give informed consent.
•History of allergy to sulfa drugs.

Locations (1)

Department of Neurology, University Hospital Essen

Essen, Germany

Key Dates

Start Date

May 1, 2008

Primary Completion Date

June 1, 2010

Completion Date

June 1, 2010

Last Updated

January 28, 2013

Enrollment

195

ACTUAL participants

Conditions

Migraine

Interventions

Rizatriptan

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Rizatriptan 10 MG RPD in the Treatment of Acute Migraine

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.