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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Hans-Christoph Diener, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01057160
First received: January 26, 2010
Last updated: January 25, 2013
Last verified: January 2013

January 26, 2010
January 25, 2013
May 2008
June 2010   (final data collection date for primary outcome measure)
Percentage of patients with headache response on a one to four scale after 2 hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01057160 on ClinicalTrials.gov Archive Site
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 Frame: (time points 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours after drug intake ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rizatriptan 10 MG RPD in the Treatment of Acute Migraine
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Migraine
Drug: Rizatriptan
use of rizatriptan 10 mg for one migraine attack, in comparison to previously used analgetic
  • Experimental: intake of rizatriptan 10 mg
    Intervention: Drug: Rizatriptan
  • Active Comparator: previous used analgesic
    Intervention: Drug: Rizatriptan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01057160
MK 462
No
Hans-Christoph Diener, Universität Duisburg-Essen
Universität Duisburg-Essen
Merck Sharp & Dohme Corp.
Principal Investigator: Hans-Christoph Diener, Prof. Department of Neurology, University Essen
Universität Duisburg-Essen
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP