Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)

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: NCT00092963
• Other study ID #: 0462-065
• Secondary ID: 2004_022
• Status: Completed
• Phase: Phase 3
• 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
• 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

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 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