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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095004
• Other study ID #: 0462-066
• Secondary ID: MK0462-0662004_0
• Status: Completed
• Phase: Phase 3
• Start date: October 21, 2004
• Est. completion date: April 4, 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: April 4, 2005
• Est. primary completion date: April 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

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 pain free at 30/45/60/90 minutes post dose
Secondary	Percentage of patients with associated symptoms at 2 hours
Secondary	Percentage of patients requiring rescue medication between 2 & 24 hours
Secondary	Percentage of patients with functional disability at 2 hours