Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
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
1 other identifier
interventional
900
1 country
19
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2013
Shorter than P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 25, 2013
CompletedFirst Posted
Study publicly available on registry
October 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
June 11, 2015
CompletedJune 11, 2015
June 1, 2015
9 months
October 25, 2013
May 20, 2015
June 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (2)
Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.
2 hours
Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.
2 hours
Study Arms (2)
Placebo
PLACEBO COMPARATOR2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Acetaminophen 250 mg and aspirin 250 mg
EXPERIMENTAL2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Interventions
2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
Eligibility Criteria
You may qualify if:
- 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.
- History of frequently or always experiencing nausea with the migraine attack.
You may not qualify if:
- 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)
- History of vomiting during more than 20% of migraine attacks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (19)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Jupiter, Florida, United States
Unknown Facility
Oviedo, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Berlin, New Jersey, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Williamsville, New York, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Kenosha, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Leader
- Organization
- Novartis
Study Officials
- STUDY DIRECTOR
Clinical Project Lead
Novartis Consumer Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2013
First Posted
October 31, 2013
Study Start
October 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
June 11, 2015
Results First Posted
June 11, 2015
Record last verified: 2015-06