Clinical trial NCT01973205: Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Migraine
Keywords: Migraine
acetaminophen
aspirin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-10-31
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Who Are Pain Free at the 2-hour Assessment
timeFrame: 2 hours
measure: Number of Subjects Who Are Nausea Free at the 2-hour Assessment
timeFrame: 2 hours
Secondary outcomes:
measure: Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.
timeFrame: 2 hours
measure: Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Ft Lauderdale
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Oviedo
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Evansville
country: United States
state: Indiana
city: Ann Arbor
country: United States
state: Michigan
city: Berlin
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Mount Pleasant
country: United States
state: South Carolina
city: Salt Lake City
country: United States
state: Utah
city: Kenosha
country: United States
state: Wisconsin
Study officials:
affiliation: Novartis Consumer Health
name: Clinical Project Lead
role: STUDY_DIRECTOR
References: