Pain, Migraine
Conditions
Keywords
Pain, Migraine
Brief summary
The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.
Interventions
DRUGAspirin, acetaminophen and caffeine
2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)
DRUGSumatriptan
100 mg Sumatriptan
DRUGPlacebo
placebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Exclusion 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, ophthalmoplegic 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. Routine use (≥ 10 days per month, on average) of any medication having the potential to interfere with the pharmacologic effects or evaluation of the study medications (e.g., narcotic and non-narcotic analgesic products (prescription or over-the-counter), ergotamine-containing and ergot-type medication, anxiolytics, hypnotics, sedatives, 5HT-1 agonists, anti-emetics, or prokinetic drugs). 3. History of vomiting during more than 20% of migraine episodes or confined to bedrest for more than 50% of migraine episodes. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Who Are Pain Free at 2 Hours. | 2 hours | Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Who Are Free of Nausea at 2 Hours. | 2 hours | Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours |
| Percent of Subjects Who Are Free of Phonophobia at 2 Hours. | 2 hours | Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours |
| Percent of Subjects Who Are Free of Photophobia at 2 Hours. | 2 hours | Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aspirin, Acetaminophen, and Caffeine 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets | 299 |
| Sumatriptan (100 mg) 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets | 304 |
| Placebo 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets | 149 |
| Total | 752 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative problem | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 9 | 12 | 4 |
| Overall Study | Pregnancy | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 0 |
Baseline characteristics
| Characteristic | Aspirin, Acetaminophen, and Caffeine | Total | Placebo | Sumatriptan (100 mg) |
|---|---|---|---|---|
| Age Continuous | 38 years STANDARD_DEVIATION 11.4 | 37.8 years STANDARD_DEVIATION 11.4 | 37.6 years STANDARD_DEVIATION 11.5 | 37.8 years STANDARD_DEVIATION 11.4 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 17 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 44 Participants | 115 Participants | 24 Participants | 47 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 19 Participants | 7 Participants | 6 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 244 Participants | 596 Participants | 113 Participants | 239 Participants |
| Region of Enrollment United States | 299 participants | 752 participants | 149 participants | 304 participants |
| Sex: Female, Male Female | 250 Participants | 620 Participants | 125 Participants | 245 Participants |
| Sex: Female, Male Male | 49 Participants | 132 Participants | 24 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 266 | 14 / 271 | 3 / 133 |
| serious Total, serious adverse events | 0 / 266 | 0 / 271 | 0 / 133 |
Outcome results
Primary
Percent of Subjects Who Are Pain Free at 2 Hours.
Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours
Time frame: 2 hours
Population: The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Instead, missing values were implicitly imputed by the repeated measures analysis statistical model. So, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspirin, Acetaminophen, and Caffeine | Percent of Subjects Who Are Pain Free at 2 Hours. | 34.7 Percent of participants |
| Sumatriptan (100 mg) | Percent of Subjects Who Are Pain Free at 2 Hours. | 44.9 Percent of participants |
| Placebo | Percent of Subjects Who Are Pain Free at 2 Hours. | 26.4 Percent of participants |
Secondary
Percent of Subjects Who Are Free of Nausea at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Time frame: 2 hours
Population: The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspirin, Acetaminophen, and Caffeine | Percent of Subjects Who Are Free of Nausea at 2 Hours. | 70.6 percent of participants |
| Sumatriptan (100 mg) | Percent of Subjects Who Are Free of Nausea at 2 Hours. | 72.2 percent of participants |
| Placebo | Percent of Subjects Who Are Free of Nausea at 2 Hours. | 66.4 percent of participants |
Secondary
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Time frame: 2 hours
Population: The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspirin, Acetaminophen, and Caffeine | Percent of Subjects Who Are Free of Phonophobia at 2 Hours. | 53.4 Percent of participants |
| Sumatriptan (100 mg) | Percent of Subjects Who Are Free of Phonophobia at 2 Hours. | 60.9 Percent of participants |
| Placebo | Percent of Subjects Who Are Free of Phonophobia at 2 Hours. | 46.2 Percent of participants |
Secondary
Percent of Subjects Who Are Free of Photophobia at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aspirin, Acetaminophen, and Caffeine | Percent of Subjects Who Are Free of Photophobia at 2 Hours. | 48.6 Percent of participants |
| Sumatriptan (100 mg) | Percent of Subjects Who Are Free of Photophobia at 2 Hours. | 52.3 Percent of participants |
| Placebo | Percent of Subjects Who Are Free of Photophobia at 2 Hours. | 40.8 Percent of participants |