Acute MigrainePhase 3NCT01973205
Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
A Phase 3 study testing Acetaminophen 250 mg and Aspirin 250 mg in people with Acute Migraine, run by Novartis at 19 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Migraine
- What is being tested?
- Acetaminophen 250 mg and Aspirin 250 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 19 sitesUnited States
- Study dates
- Oct 2013to Jul 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects eligible for inclusion in this study must not fulfill any of the following criteria:
- 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)
Show all 10Show fewer
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Anaheim, California
Study site
Ann Arbor, Michigan
Study site
Berlin, New Jersey
Study site
Birmingham, Alabama
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Evansville, Indiana
Study site
Fort Lauderdale, Florida
Study site
Jupiter, Florida
Study site
Kenosha, Wisconsin
Study site
Mt. Pleasant, South Carolina
Study site
Oviedo, Florida
Study site
Raleigh, North Carolina
Study site
Rochester, New York
Study site
Salt Lake City, Utah
Study site
San Francisco, California
Study site
The Bronx, New York
Study site
West Palm Beach, Florida
Study site
Williamsville, New York
About this study
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
The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine
- Conditions
- Acute Migraine
- Being tested
- Acetaminophen 250 mg and Aspirin 250 mg, Placebo
- Keywords
- Migraine, acetaminophen, aspirin
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen 250 mg and Aspirin 250 mgDrug
2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
PlaceboDrug
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets Receives: Drug: Placebo |
| Acetaminophen 250 mg and aspirin 250 mg | Experimental | 2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg Receives: Drug: Acetaminophen 250 mg and Aspirin 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Are Pain Free at the 2-hour Assessment
Number of subjects who are pain free at the 2-hour assessment
Measured: 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
Measured: 2 hours
Secondary outcomes (2)
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.
Measured: 2 hours
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Project Lead, Study director, Novartis Consumer Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973205
- Sponsor's protocol ID
- 863-P-303
- Status last verified
- Jun 2015
- First submitted
- 25 Oct 2013
- Last updated
- 11 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01973205
- Acronym / sponsor ID
- 863-P-303
- Conditions
- Acute Migraine
- Keywords
- Migraine, acetaminophen, aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Posted 11 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets |
| Acetaminophen 250 mg and aspirin 250 mg | Experimental | Drug: Acetaminophen 250 mg and Aspirin 250 mg2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Subjects eligible for inclusion in this study must not fulfill any of the following criteria:
- Headache symptoms which may be due to or aggravated by:
- History of vomiting during more than 20% of migraine attacks.
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen 250 mg and Aspirin 250 mg2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg | Drug | Acetaminophen 250 mg and aspirin 250 mg |
| Placebo2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets | Drug | Placebo |
Primary outcome
Number of Subjects Who Are Pain Free at the 2-hour Assessment
Time frame: 2 hours
Number of subjects who are pain free at the 2-hour assessment
Number of Subjects Who Are Nausea Free at the 2-hour Assessment
Time frame: 2 hours
Number of subjects who are nausea free at the 2-hour assessment
2 secondary outcomes
Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.
Time frame: 2 hours
Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Project Lead study director
Novartis Consumer Health
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetaminophen 250 mg and Aspirin 250 mg in people with Acute Migraine, run by Novartis at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Are Pain Free at the 2-hour Assessment (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.