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
Brief Title
Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Migraine
Eligibility Criteria
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/exclusion criteria may apply
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/exclusion criteria may apply
Inclusion Criteria
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.
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/
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.
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/
Gender
All
Gender Based
false
Keywords
Migraine
acetaminophen
aspirin
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01973205
Org Class
Industry
Org Full Name
Novartis
Org Study Id
863-P-303
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Number of subjects who are pain free at the 2-hour assessment
Outcome Measure
Number of Subjects Who Are Pain Free at the 2-hour Assessment
Outcome Time Frame
2 hours
Outcome Description
Number of subjects who are nausea free at the 2-hour assessment
Outcome Measure
Number of Subjects Who Are Nausea Free at the 2-hour Assessment
Outcome Time Frame
2 hours
Secondary Outcomes
Outcome Description
Number of subjects who are free of photophobia at the 2-hour assessment.
Outcome Time Frame
2 hours
Outcome Measure
Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.
Outcome Description
Number of subjects who are free of phonophobia at the 2-hour assessment.
Outcome Time Frame
2 hours
Outcome Measure
Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Brian Grosberg
Investigator Email
bgrosber@montefiore.org
Investigator Phone