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Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092963
First received: September 28, 2004
Last updated: March 31, 2017
Last verified: March 2017
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Purpose
The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine while the pain is still mild.
| 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 Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Percentage of patients who are pain free at 2 hours postdose.
- Tolerability as measured by subjective adverse experience reporting.
Secondary Outcome Measures:
- Percentage of patients with 24 hour sustained pain freedom
- Percentage of patients free at 30/45/60/90 minutes postdose
- Percentage of patients with associated symptoms at 2 hours
- Percentage of patients requiring rescue med between 2 & 24 hours
- Percentage of patients with functional disability at 2 hours
| Enrollment: | 529 |
| Actual Study Start Date: | August 17, 2004 |
| Study Completion Date: | January 14, 2005 |
| Primary Completion Date: | January 14, 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 6-month history of migraine
- Migraine attacks typically mild when they begin with 1-4 migraine attacks per month
Exclusion Criteria:
- Heart disease
- High blood pressure
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: NCT00092963
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092963
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Publications:
Study Data/Documents: CSR Synopsis
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00092963 History of Changes |
| Other Study ID Numbers: |
0462-065 2004_022 |
| Study First Received: | September 28, 2004 |
| Last Updated: | March 31, 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 |
ClinicalTrials.gov processed this record on July 18, 2017