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Completed

NCT Number: NCT00300924

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SanFrancisco Headache Clinic, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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*

Treatment and study plan

Rizatriptan co-administered with Acetaminophen

Drug

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

Sponsors and collaborators

Lead sponsor

Diamond Headache Clinic

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 10, 2006
Registry last updated
May 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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