Trial Outcomes & Findings for Smell Sensitivity in Chronic Migraine: A Case-Control Study (NCT NCT01687088)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

Chronic migraineurs up to 12 months. Controls up to 2 weeks.

Results posted on

2014-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Smell Sensitivity in Chronic Migraine: A Case-Control Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Migraineurs n=50 Participants At least 8 migraine days per week and headache at least 15 days per month.	Controls n=50 Participants No significant headache or disability as defined by migraine disability scale.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Chronic migraineurs up to 12 months. Controls up to 2 weeks.

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.

Outcome measures

Outcome measures
Measure	Chronic Migraineurs n=40 Participants At least 8 migraine days per week and headache at least 15 days per month.	Controls n=47 Participants No significant headache or disability as defined by migraine disability scale.
Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points First UPSIT Score	34.5 UPSIT Score Standard Error 0.4	35.9 UPSIT Score Standard Error 0.1
Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points Second UPSIT Score	34.7 UPSIT Score Standard Error 0.4	36.1 UPSIT Score Standard Error 0.1

Adverse Events

Chronic Migraineurs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael J. Marmura, MD

Thomas Jefferson University

Phone: 215-955-2243

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place