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CompletedNCT00300924Updated May 28, 2008

A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine

A Phase 3 interventional study of Rizatriptan co-administered with Acetaminophen in Migraine, sponsored by Diamond Headache Clinic. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-05-28.

Sponsored by Diamond Headache Clinic · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.

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 200 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

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Lead sponsor

Diamond Headache Clinic is the lead sponsor of 4 studies on the registry; none are open to participants now.

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

  • Subject is at least 18 years of age
  • Subject has at least a 6 month history of migraine, with or without aura
  • Subject can distinguish between migraine attacks and other types of headaches
  • Subject of childbearing potential agrees to use adequate contraception

Exclusion criteria

Exclusion Criteria:

  • Subject typically has fewer than 1 or greater than 6 migraine attacks per month
  • Subject typically has greater than 10 headache days per month
  • Subject has evidence of ischemic heart disease
  • Subject has uncontrolled high blood pressure
  • Subject has a history, within 1 year, or current evidence of drug or alcohol abuse

*This list is not all inclusive*

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
200 participants

Interventions

  • DrugRizatriptan co-administered with Acetaminophen
06

What researchers measure

Primary outcomes

  1. To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours.

Secondary outcomes

  1. 24 hour sustained pain relief

  2. Pain relief at 30, 45,60,90 minutes and 4 hours post dose

  3. Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose

  4. 24 sustained pain freedom

  5. Associated symptoms of phonophobia, photophobia, nausea and vomiting

  6. Functional disability

  7. Use of rescue medication

  8. Self-reported adverse experiences

07

Study locations

7 sites
  • SanFrancisco Headache Clinic
    San Francisco, California 94109, United States
  • Diamond Headache Clinic
    Chicago, Illinois 60614, United States
  • Westside Family Medical Center
    Kalamazoo, Michigan 49009, United States
  • Clinvest
    Springfield, Missouri, United States
  • Mercy Health Research
    St. Louis, Missouri 63141, United States
  • Elkind Headache Center
    Mount Vernon, New York 10550, United States
  • ClinExcel
    West Chester, Ohio 44121, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00300924
Lead sponsor
Diamond Headache Clinic
Collaborators
Merck Sharp & Dohme LLC
First posted
Mar 10, 2006
Start date
Mar 2006
Primary completion
Jan 2007
Completion
Jan 2007
Last update
May 28, 2008

Study contacts

Merle Diamond, M.D.
study director · Diamond Headache Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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