Phase 3
Completed N=900
Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
Source: ClinicalTrials.gov NCT01973205 ↗Enrolled (actual)
900
Serious AEs
0.1%
Results posted
Jun 2015
Primary outcomePrimary: Number of Subjects Who Are Pain Free at the 2-hour Assessment — 69; 90 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Are Pain Free at the 2-hour Assessment |
69; 90 | — |
| PRIMARY Number of Subjects Who Are Nausea Free at the 2-hour Assessment |
208; 244 | — |
| SECONDARY Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. |
116; 127 | — |
| SECONDARY Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. |
142; 164 | — |
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria
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)
- 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
Data sourced from ClinicalTrials.gov (NCT01973205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.