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
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