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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00092963
Other study ID # 0462-065
Secondary ID 2004_022
Status Completed
Phase Phase 3
First received
Last updated
Start date August 17, 2004
Est. completion date January 14, 2005

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 529
Est. completion date January 14, 2005
Est. primary completion date January 14, 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MK0462, rizatriptan benzoate / Duration of Treatment: 1day

Comparator: placebo / Duration of Treatment: 1 day


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

References & Publications (4)

Cady 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. Epub 2007 Aug 6. — View Citation

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. — View Citation

Ho 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. — View Citation

Martin 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. Epub 2007 Nov 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients who are pain free at 2 hours postdose.
Primary Tolerability as measured by subjective adverse experience reporting.
Secondary Percentage of patients with 24 hour sustained pain freedom
Secondary Percentage of patients free at 30/45/60/90 minutes postdose
Secondary Percentage of patients with associated symptoms at 2 hours
Secondary Percentage of patients requiring rescue med between 2 & 24 hours
Secondary Percentage of patients with functional disability at 2 hours
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