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CompletedNCT00095004Updated Aug 14, 2024

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

A Phase 3 interventional study of MK0462, rizatriptan benzoate / Duration of Treatment: 1day and Comparator: placebo / Duration of Treatment: 1 day in Migraine, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.

02

Conditions studied

  • Migraine

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03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 167 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month.

Exclusion criteria

Exclusion Criteria:

  • Heart disease
  • High blood pressure
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
167 participants (actual)

Interventions

  • DrugMK0462, rizatriptan benzoate / Duration of Treatment: 1day
  • DrugComparator: placebo / Duration of Treatment: 1 day
06

What researchers measure

Primary outcomes

  1. Percentage of patients who are pain free at 2 hours postdose

  2. Tolerability as measured by subjective adverse experience reporting

Secondary outcomes

  1. Percentage of patients with 24 hour sustained pain freedom

  2. Percentage of patients pain free at 30/45/60/90 minutes post dose

  3. Percentage of patients with associated symptoms at 2 hours

  4. Percentage of patients requiring rescue medication between 2 & 24 hours

  5. Percentage of patients with functional disability at 2 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 16732837 ↗
  • 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. doi: 10.1111/j.1526-4610.2007.00947.x. Epub 2007 Nov 13. PubMed 18005144 ↗
  • 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. doi: 10.1111/j.1468-2982.2007.01391.x. Epub 2007 Aug 6. PubMed 17681023 ↗
  • 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. PubMed 19222588 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00095004
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Nov 1, 2004
Start date
Oct 21, 2004
Primary completion
Apr 1, 2005
Completion
Apr 4, 2005
Last update
Aug 14, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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