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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Olfactory impairment is a common symptom of neurologic disorders and may be related to dopaminergic dysfunction. Studies show that patients with migraine show increased sensitivity to light and sound. In our previous study in episodic migraineurs, olfaction was similar to age and sex-matched controls outside of attacks, but lower during acute attacks.
The hypothesis is that olfactory function in chronic migraine (CM) will have mild impairment of olfaction at baseline but a more significant impairment during migraine or headache exacerbations.
The investigators have two objectives:
To execute this study, the investigators will interview subjects and controls to ensure that they meet inclusion and exclusion criteria. After obtaining informed consent, subjects and controls will complete a questionnaire survey regarding their history or lack of history of headaches, smell sensitivity, osmophobia and current medication use and answer questions about attack frequency, location of headache, duration of disease, use of medication for pain, and disability. Both migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office.
After the first visit, migraineurs and controls will self-administer the UPSIT at home. They will be required to return the second test to the Jefferson Headache Center.
The investigators will use analysis of variance (ANOVA) to determine variance in UPSIT scores between subjects and controls. To achieve a 90% power that the study will detect a statistically significant difference between the mean UPSIT scores at a two-sided 5 percent significance level, our sample size for both subjects and controls is 50.
The investigators will interview subjects and controls to ensure that they meet inclusion criteria and do not meet exclusion criteria. After obtaining informed consent, subjects and controls will complete a questionnaire survey with the interviewer regarding their history of headaches, smell sensitivity, osmophobia and current medication use. Subjects will also answer questions about attack frequency, location of headache, duration of disease, use of medication for pain, and disability.
After completing the questionnaire survey, migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office. During this visit we will demonstrate and give instructions on how to perform UPSIT at home.
After the first visit, migraineurs will self-administer the UPSIT during a migraine attack day at home. They will be required to mail or drop off the second test at the Jefferson Headache Center.
Age and sex matched controls will take the first UPSIT in the office. They will take second UPSIT 2 weeks later at home and call the Headache Center to notify the staff that they have completed the second UPSIT. They will be asked to mail or drop off the test at the Jefferson Headache Center.
The UPSIT is a standardized, validated test for olfaction. There are a total of 40 odorants, with four booklets each containing ten odorants. The stimuli are embedded in "scratch and sniff" microcapsules at the bottom of each page. Subjects must choose one answer among four possible answers for each odorant - a forced choice test. The validity and reliability of the UPSIT, as well as the basis for using these particular odorants, has been demonstrated in multiple studies. The tests kits will be supplied by Dr. Richard Doty at University of Pennsylvania.
The investigators will use analysis of variance (ANOVA) to determine variance in UPSIT scores between subjects and controls. We will also use ANOVA to examine differences based on subject characteristics, including attack frequency, duration of illness, osmophobia during attacks, and if odors trigger headaches. The investigators will also use Chi-square and the Wilcoxon rank sum test to determine categorical outcomes such as gender and statistical significance between groups.
To achieve a 90% power that the study will detect a statistically significant difference between the mean UPSIT scores at a two-sided 5 percent significance level, our sample size for both subjects and controls is 50. This is based on the assumption that the standard deviation of the response variable is 3 units. The investigator's assumptions about effect size are based on previous studies using the UPSIT to detect differences in subjects and controls in other neurologic disorders, such as schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chronic migraineurs | At least 8 migraine days per week and headache at least 15 days per month. | ||
| controls | No significant headache or disability as defined by migraine disability scale. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points | Migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office. The UPSIT test is a series of 40 questions and the score is the number of questions answered correctly. Each question is multiple choice and must be answered. The number of correct answers regarding the smells being experienced is the subjects score. The higher the score the better the sense of smell. This allows groups to be compared. In this study after the first visit, migraineurs will be given the UPSIT test without a headache and then they will self-administer the UPSIT during a migraine attack day at home. Age and sex matched controls will also take the first UPSIT in the office. They will take second UPSIT 2 weeks later at home. | Chronic migraineurs up to 12 months. Controls up to 2 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female subjects, over age 18 years who meet criteria for diagnosis of chronic migraine Controls will be age and sex-matched and will have no history of migraine
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| Name | Affiliation | Role |
|---|---|---|
| Michael McNamara, MD | Thomas Jefferson University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Migraineurs | At least 8 migraine days per week and headache at least 15 days per month. |
| FG001 | Controls | No significant headache or disability as defined by migraine disability scale. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Migraineurs | At least 8 migraine days per week and headache at least 15 days per month. |
| BG001 | Controls | No significant headache or disability as defined by migraine disability scale. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points | Migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office. The UPSIT test is a series of 40 questions and the score is the number of questions answered correctly. Each question is multiple choice and must be answered. The number of correct answers regarding the smells being experienced is the subjects score. The higher the score the better the sense of smell. This allows groups to be compared. In this study after the first visit, migraineurs will be given the UPSIT test without a headache and then they will self-administer the UPSIT during a migraine attack day at home. Age and sex matched controls will also take the first UPSIT in the office. They will take second UPSIT 2 weeks later at home. | Posted | Mean | Standard Error | UPSIT Score | Chronic migraineurs up to 12 months. Controls up to 2 weeks. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic Migraineurs | At least 8 migraine days per week and headache at least 15 days per month. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael J. Marmura, MD | Thomas Jefferson University | 215-955-2243 | michael.marmura@jefferson.edu |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
At least 8 migraine days per week and headache at least 15 days per month.
| OG001 | Controls | No significant headache or disability as defined by migraine disability scale. |
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Controls | No significant headache or disability as defined by migraine disability scale. | 0 | 50 | 0 | 50 |
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