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Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)

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ClinicalTrials.gov Identifier: NCT00111709
Recruitment Status : Completed
First Posted : May 25, 2005
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.

Condition or disease Intervention/treatment Phase
Migraine Drug: MK0462, rizatriptan benzoate / Duration of Treatment -1 day Drug: Comparator: placebo / Duration of Treatment - 1 day Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 393 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine
Actual Study Start Date : May 27, 2005
Primary Completion Date : February 24, 2006
Study Completion Date : February 26, 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Rizatriptan
U.S. FDA Resources

Primary Outcome Measures :
  1. Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary

Secondary Outcome Measures :
  1. Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female patient at least 18 years old
  • Patient has menses approximately monthly
  • Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine

Exclusion Criteria:

  • Pregnant and/or nursing
  • Cardiovascular disease
  • Uncontrolled hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111709

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00111709     History of Changes
Other Study ID Numbers: 0462-071
First Posted: May 25, 2005    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

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