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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:11/8/2014
Start Date:October 2013
End Date:July 2014
Contact:Novartis Clinical Project Leader
Phone:973-503-7812

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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

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


Inclusion criteria:

1. Male or female aged 18 years and over.

2. International Headache Society (IHS) diagnosis of migraine without aura or typical
aura with migraine headache.

3. History of experiencing at least 1, but not more than 8, acute migraine attacks
monthly during the previous year.

4. History of at least moderate migraine pain intensity, if left untreated.

5. 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:

1. 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)

2. History of vomiting during more than 20% of migraine attacks.

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
19
sites
492
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from 43215
Birmingham, AL
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1962
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Anaheim, CA
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164
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Ann Arbor, MI
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428
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Berlin, NJ
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482
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Bronx, NY
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98
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Cincinnati, OH
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127
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Cleveland, OH
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280
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Evansville, IN
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966
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Ft Lauderdale, FL
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916
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Jupiter, FL
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308
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Kenosha, WI
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Mount Pleasant, South Carolina 29464
524
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Mount Pleasant, SC
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788
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Oviedo, FL
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371
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Raleigh, NC
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355
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Rochester, NY
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1513
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Salt Lake City, UT
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2107
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San Francisco, CA
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931
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West Palm Beach, FL
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304
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from 43215
Williamsville, NY
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