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

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.

Exclusion 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, 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