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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01057160
Other study ID # MK 462
Secondary ID
Status Completed
Phase Phase 4
First received January 26, 2010
Last updated January 25, 2013
Start date May 2008
Est. completion date June 2010

Study information

Verified date January 2013
Source Universität Duisburg-Essen
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Department of Neurology, University Hospital Essen Essen

Sponsors (2)

Lead Sponsor Collaborator
Universität Duisburg-Essen Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with headache response on a one to four scale after 2 hours. 2 hours No
Secondary 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 No
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