Acute Migraine
Conditions
Keywords
Migraine, acetaminophen, aspirin
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
Interventions
DRUGAcetaminophen 250 mg and Aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
DRUGPlacebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Are Pain Free at the 2-hour Assessment | 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 | 2 hours | Number of subjects who are nausea free at the 2-hour assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. | 2 hours | Number of subjects who are free of photophobia at the 2-hour assessment. |
| Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. | 2 hours | Number of subjects who are free of phonophobia at the 2-hour assessment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets | 453 |
| Acetaminophen 250 mg and Aspirin 250 mg 2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg | 447 |
| Total | 900 |
Baseline characteristics
| Characteristic | Placebo | Total | Acetaminophen 250 mg and Aspirin 250 mg |
|---|---|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 12.4 | 40.1 years STANDARD_DEVIATION 12.6 | 39.7 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants | 96 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 405 Participants | 804 Participants | 399 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 96 Participants | 201 Participants | 105 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 31 Participants | 18 Participants |
| Race (NIH/OMB) White | 337 Participants | 655 Participants | 318 Participants |
| Region of Enrollment United States | 453 participants | 900 participants | 447 participants |
| Sex: Female, Male Female | 351 Participants | 701 Participants | 350 Participants |
| Sex: Female, Male Male | 102 Participants | 199 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 415 | 0 / 408 |
| serious Total, serious adverse events | 0 / 415 | 1 / 408 |
Outcome results
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
Time frame: 2 hours
Population: Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N=415) and had a non-missing nausea free status at 2 hours (AA: N=403, Placebo N= 411).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Subjects Who Are Nausea Free at the 2-hour Assessment | 208 participants |
| Acetaminophen 250 mg and Aspirin 250 mg | Number of Subjects Who Are Nausea Free at the 2-hour Assessment | 244 participants |
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
Time frame: 2 hours
Population: Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing pain free status at 2 hours (AA: N=408, Placebo: N = 415).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Subjects Who Are Pain Free at the 2-hour Assessment | 69 participants |
| Acetaminophen 250 mg and Aspirin 250 mg | Number of Subjects Who Are Pain Free at the 2-hour Assessment | 90 participants |
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.
Time frame: 2 hours
Population: Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing phonophobia free status at 2 hours (AA: N=403, Placebo: N = 411).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. | 142 participants |
| Acetaminophen 250 mg and Aspirin 250 mg | Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. | 164 participants |
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.
Time frame: 2 hours
Population: Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing photophobia free status at 2 hours (AA: N=403, Placebo: N = 411).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. | 116 participants |
| Acetaminophen 250 mg and Aspirin 250 mg | Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. | 127 participants |