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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Migraine

Intervention / Treatment
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* Drug: Aspirin, acetaminophen and caffeine
* Drug: Sumatriptan
* 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. 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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin, acetaminophen and caffeine<br>AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets | Drug: Aspirin, acetaminophen and caffeine<br>* 2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)<br>|
| Active Comparator: Sumatriptan (100 mg)<br>1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets | Drug: Sumatriptan<br>* 100 mg Sumatriptan<br>|
| Placebo Comparator: Placebo<br>1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects Who Are Pain Free at 2 Hours. | Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects Who Are Free of Nausea at 2 Hours. | Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours | 2 hours | 
| Percent of Subjects Who Are Free of Phonophobia at 2 Hours. | Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours | 2 hours | 
| Percent of Subjects Who Are Free of Photophobia at 2 Hours. | Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours | 2 hours | 

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