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
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: Rizatriptan
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Percentage of patients with headache response on a one to four scale after 2 hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 195
Study Start Date: May 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057160

Locations
Germany
Department of Neurology, University Hospital Essen
Essen, Germany, 45147
Sponsors and Collaborators
Universität Duisburg-Essen
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Hans-Christoph Diener, Prof. Department of Neurology, University Essen
  More Information

No publications provided

Responsible Party: Hans-Christoph Diener, Prof. of Neurology, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01057160     History of Changes
Other Study ID Numbers: MK 462
Study First Received: January 26, 2010
Last Updated: January 25, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014