Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine

Completed · Phase 4 · Has a placebo group

Conditions studied: Pain, Migraine

In brief

The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.

Key facts

Study ID

NCT01248468

Run by

Novartis

People needed

752

Starts

2010-11-01

Expected to finish

2011-03-01

Last updated by the study team

2012-07-30

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.

You may not qualify if…

• 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, ophthalmoplegic 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)
• Routine use (≥ 10 days per month, on average) of any medication having the potential to interfere with the pharmacologic effects or evaluation of the study medications (e.g., narcotic and non-narcotic analgesic products (prescription or over-the-counter), ergotamine-containing and ergot-type medication, anxiolytics, hypnotics, sedatives, 5HT-1 agonists, anti-emetics, or prokinetic drugs).
• History of vomiting during more than 20% of migraine episodes or confined to bedrest for more than 50% of migraine episodes.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Study site — Anaheim, California, United States
• Study site — San Francisco, California, United States
• Study site — Clearwater, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Springfield, Missouri, United States
• Study site — Rochester, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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