Rizatriptan 10 MG RPD in the Treatment of Acute Migraine

NCT ID: NCT01057160

Last Updated: 2013-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-06-30

Brief 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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intake of rizatriptan 10 mg

Group Type: EXPERIMENTAL

Rizatriptan

Intervention Type: DRUG

use of rizatriptan 10 mg for one migraine attack, in comparison to previously used analgetic

previous used analgesic

Group Type: ACTIVE_COMPARATOR

Rizatriptan

Intervention Type: DRUG

use of rizatriptan 10 mg for one migraine attack, in comparison to previously used analgetic

Interventions

Rizatriptan

use of rizatriptan 10 mg for one migraine attack, in comparison to previously used analgetic

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role: lead

Responsible Party

Hans-Christoph Diener

Prof. of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans-Christoph Diener, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University Essen

Locations

Department of Neurology, University Hospital Essen

Essen, , Germany

Countries

Germany

Other Identifiers

MK 462

Identifier Type: -

Identifier Source: org_study_id