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

Novartis

Status and phase: Completed; Phase 4

Conditions: Pain, Migraine

Treatments: Drug: Sumatriptan; Drug: Aspirin, acetaminophen and caffeine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01248468

176-P-401

Details and patient eligibility

About

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.

Enrollment: 752 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.

Exclusion 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, 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)

2. 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).

3. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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752 participants in 3 patient groups, including a placebo group

Aspirin, acetaminophen and caffeine

Experimental group

Description:

AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets

Treatment:

Drug: Aspirin, acetaminophen and caffeine

Sumatriptan (100 mg)

Active Comparator group

Description:

1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets

Treatment:

Drug: Sumatriptan

Placebo

Placebo Comparator group

Description:

1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets

Treatment:

Drug: Placebo