Rizatriptan 10 MG RPD in the Treatment of Acute Migraine (Rinotama)

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Rizatriptan

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45147
    • Department of Neurology, University Hospital Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intake of rizatriptan 10 mg	Drug: Rizatriptan; use of rizatriptan 10 mg for one migraine attack, in comparison to previously used analgetic
Active Comparator: previous used analgesic	Drug: Rizatriptan; use of rizatriptan 10 mg for one migraine attack, in comparison to previously used analgetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with headache response on a one to four scale after 2 hours.	2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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	(time points 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours after drug intake

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Hans-Christoph Diener, Prof., Department of Neurology, University Essen

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 26, 2010
• First Posted (Estimate): January 27, 2010

Study Record Updates

• Last Update Posted (Estimate): January 28, 2013
• Last Update Submitted That Met QC Criteria: January 25, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Rizatriptan
• Other Study ID Numbers: MK 462