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Completed

NCT Number: NCT01973205

Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine

The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine

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Key information

Conditions

Acute 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

Birmingham, Alabama, 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

  • Male or female aged 18 years and over.
  • International Headache Society (IHS) diagnosis of migraine without aura or typical aura with migraine headache.
  • History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year.
  • History of at least moderate migraine pain intensity, if left untreated.
  • History of frequently or always experiencing nausea with the migraine attack.

Exclusion criteria

Subjects eligible for inclusion in this study must not fulfill any of the following criteria:

  • Headache symptoms which may be due to or aggravated by:
  • Recent (within 6 months) head or neck trauma (e.g., whiplash)
  • Head or neck pain secondary to an orthopedic abnormality
  • Cluster headache
  • Specific migraine variants (e.g., basilar-type artery migraine, opthalmoplegic migraine, hemiplegic migraine, migraine aura without headache)
  • Other serious, non-migraine causes of headache (e.g., increased intracranial pressure, intracranial bleeding, meningitis, malignancy)
  • Non-serious, non-migraine causes of headache (e.g., cold, flu, hangover)
  • History of vomiting during more than 20% of migraine attacks.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Acetaminophen 250 mg and Aspirin 250 mg

Drug

2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg

Placebo

Drug

2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets

Primary outcomes

  1. Number of Subjects Who Are Pain Free at the 2-hour Assessment

    Time frame: 2 hours

    Number of subjects who are pain free at the 2-hour assessment

  2. Number of Subjects Who Are Nausea Free at the 2-hour Assessment

    Time frame: 2 hours

    Number of subjects who are nausea free at the 2-hour assessment

Secondary outcomes

  1. Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.

    Time frame: 2 hours

    Number of subjects who are free of photophobia at the 2-hour assessment.

  2. Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.

    Time frame: 2 hours

    Number of subjects who are free of phonophobia at the 2-hour assessment.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Parallel-group, Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of a Combination of Acetaminophen and Aspirin vs Placebo in the Acute Treatment of Migraine

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2013
Registry last updated
Jun 11, 2015

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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