Clinical trial NCT01057160: Rizatriptan 10 MG RPD in the Treatment of Acute Migraine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-01-27
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of patients with headache response on a one to four scale after 2 hours.
timeFrame: 2 hours
Secondary outcomes:
measure: 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
timeFrame: (time points 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours after drug intake
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Neurology, University Hospital Essen
Study officials:
affiliation: Department of Neurology, University Essen
name: Hans-Christoph Diener, Prof.
role: PRINCIPAL_INVESTIGATOR
References: