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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Migraine

In brief

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

Key facts

Study ID

NCT01973205

Run by

Novartis

People needed

900

Starts

2013-10-01

Expected to finish

2014-07-01

Last updated by the study team

2015-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Anaheim, California, United States
• Study site — San Francisco, California, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Oviedo, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Evansville, Indiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Berlin, New Jersey, United States
• Study site — Rochester, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Williamsville, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Kenosha, Wisconsin, United States

Full record on ClinicalTrials.gov

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