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Rizatriptan 10 MG RPD in the Treatment of Acute Migraine

Information source: Universität Duisburg-Essen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: Rizatriptan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Universität Duisburg-Essen

Official(s) and/or principal investigator(s):
Hans-Christoph Diener, Prof., Principal Investigator, Affiliation: Department of Neurology, University Essen

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of patients with headache response on a one to four scale after 2 hours.

Secondary outcome: Percentage of patients being headache free two hours after intake of study medication. Time of dosing to onset of headache relieve. Relief of concomitant symptoms. Rate of sustained pain free Percentage of patients needing rescue medication

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Department of Neurology, University Hospital Essen, Essen 45147, Germany
Additional Information

Starting date: May 2008
Last updated: January 25, 2013

Page last updated: August 23, 2015

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