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

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

Official Title
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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

Conditions
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Acute Migraine

Intervention / Treatment
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* Drug: Acetaminophen 250 mg and Aspirin 250 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets | Drug: Placebo<br>* 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets<br>|
| Experimental: Acetaminophen 250 mg and aspirin 250 mg<br>2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg | Drug: Acetaminophen 250 mg and Aspirin 250 mg<br>* 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Are Pain Free at the 2-hour Assessment | Number of subjects who are pain free at the 2-hour assessment | 2 hours | 
| Number of Subjects Who Are Nausea Free at the 2-hour Assessment | Number of subjects who are nausea free at the 2-hour assessment | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. | Number of subjects who are free of photophobia at the 2-hour assessment. | 2 hours | 
| Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. | Number of subjects who are free of phonophobia at the 2-hour assessment. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, acetaminophen, aspirin