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

Novartis

Status and phase: Completed; Phase 3

Conditions: Acute Migraine

Treatments: Drug: Acetaminophen 250 mg and Aspirin 250 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01973205

863-P-303

Details and patient eligibility

About

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

Enrollment: 900 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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900 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets

Treatment:

Drug: Placebo

Acetaminophen 250 mg and aspirin 250 mg

Experimental group

Description:

2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg

Treatment:

Drug: Acetaminophen 250 mg and Aspirin 250 mg