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

Launched by NOVARTIS · Oct 25, 2013

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Eligibility criteria

• 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