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

Acute Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973205
• Other study ID #: 863-P-303
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2013
• Last updated: June 9, 2015
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Drug:
• Acetaminophen 250 mg and Aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
• Placebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No