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Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)

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ClinicalTrials.gov Identifier: NCT00095004
Recruitment Status : Completed
First Posted : November 1, 2004
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild
Actual Study Start Date : October 21, 2004
Actual Primary Completion Date : April 1, 2005
Actual Study Completion Date : April 4, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Rizatriptan
U.S. FDA Resources




Primary Outcome Measures :
  1. Percentage of patients who are pain free at 2 hours postdose
  2. Tolerability as measured by subjective adverse experience reporting

Secondary Outcome Measures :
  1. Percentage of patients with 24 hour sustained pain freedom
  2. Percentage of patients pain free at 30/45/60/90 minutes post dose
  3. Percentage of patients with associated symptoms at 2 hours
  4. Percentage of patients requiring rescue medication between 2 & 24 hours
  5. Percentage of patients with functional disability at 2 hours


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:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month.

Exclusion Criteria:

  • Heart disease
  • High blood pressure

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): NCT00095004


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

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00095004     History of Changes
Other Study ID Numbers: 0462-066
MK0462-066
2004_089
First Posted: November 1, 2004    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
Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs