Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)
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
2 other identifiers
interventional
529
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2004
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 17, 2004
CompletedFirst Submitted
Initial submission to the registry
September 28, 2004
CompletedFirst Posted
Study publicly available on registry
September 29, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2005
CompletedAugust 14, 2024
February 1, 2022
5 months
September 28, 2004
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of patients who are pain free at 2 hours postdose.
Tolerability as measured by subjective adverse experience reporting.
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- month history of migraine
- Migraine attacks typically mild when they begin with 1-4 migraine attacks per month
You may not qualify if:
- Heart disease
- High blood pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (4)
Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of Rizatriptan 10 mg administered early in a migraine attack. Headache. 2006 Jun;46(6):914-24. doi: 10.1111/j.1526-4610.2006.00466.x.
PMID: 16732837BACKGROUNDMartin V, Cady R, Mauskop A, Seidman LS, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of rizatriptan for menstrual migraine in an early intervention model: a prospective subgroup analysis of the rizatriptan TAME (Treat A Migraine Early) studies. Headache. 2008 Feb;48(2):226-35. doi: 10.1111/j.1526-4610.2007.00947.x. Epub 2007 Nov 13.
PMID: 18005144BACKGROUNDCady R, Martin V, Mauskop A, Rodgers A, Hustad C, Ramsey K, Skobieranda F. Symptoms of cutaneous sensitivity pre-treatment and post-treatment: results from the rizatriptan TAME studies. Cephalalgia. 2007 Sep;27(9):1055-60. doi: 10.1111/j.1468-2982.2007.01391.x. Epub 2007 Aug 6.
PMID: 17681023BACKGROUNDHo TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.
PMID: 19222588BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2004
First Posted
September 29, 2004
Study Start
August 17, 2004
Primary Completion
January 14, 2005
Study Completion
January 14, 2005
Last Updated
August 14, 2024
Record last verified: 2022-02