Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-072)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00111722
First received: May 24, 2005
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

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

Enrollment: 393
Study Start Date: May 2005
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant and/or nursing mother
  • Cardiovascular disease
  • Uncontrolled hypertension
  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: NCT00111722

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

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00111722     History of Changes
Other Study ID Numbers: 2005_025, MK0462-072
Study First Received: May 24, 2005
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

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 August 27, 2014