- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386880
Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs
August 4, 2014 updated by: Thomas Jefferson University
Cutaneous allodynia is an increased skin sensitivity experienced during a headache.
It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache.
Understanding more about the occurrence of phonophobia (increased sensitivity to sound) and allodynia may help us understand how the pain system works in migraine.
It is hoped that the knowledge gained from this trial may enable us to more effectively treat patients with migraine headache.
Study Overview
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Jefferson Headache Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult women and men with a diagnosis of episodic migraine
Description
Inclusion Criteria:
Inclusion criteria for migraine subjects:
- Age: 18 - 65 years, inclusive.
- Gender: male or female
- Diagnosis: Episodic migraine with or without aura, as defined by the International Headache Society (IHS), for at least 6 months prior to enrollment.
- An average of ≥1 migraine attack per month over the 6-month period prior to enrollment.
- An average of <15 headache (of any type) days per month for the 6 months prior to enrollment.
- Normal audiogram. (A hearing threshold of 20 dB or less at the frequency range of 200-8000Hz.).
Inclusion criteria for control subjects:
- Age: 18 - 65 years, inclusive.
- Gender: male or female
- Non-headache sufferers with the exception of infrequent ETTH according to IHS criteria (lifetime occurrence of at least 10 episodes occurring on <1 day per month on average and <12 days per year)
- Normal audiogram, (A hearing threshold of 20 dB or less at the frequency range of 200-8000Hz.).
Exclusion criteria for migraine subjects:
- Any other headache diagnosis (e.g. cluster headache, hemicrania continua, post traumatic headache, etc.) except for episodic tension type headache (ETTH) with an average of no more than 10 ETTH headache days per month for the 6 months prior to enrollment (note: average <15 total HA days is specified in inclusion)
- Use of any headache preventive drug (determined by investigator) in the 90 days prior to screening.
- Treatment with botulinum toxin (for any indication) within the 90 day period prior to enrollment.
- Treatment with occipital nerve block or block, or block of any other nerve in the head or neck area, within the 30 day period prior to enrollment.
- Any dermatological disease that may affect skin sensation.
- Any neurological disease that may affect sensory functions (e.g stroke, multiple sclerosis, peripheral neuropathy).
- Cognitive disturbance that may affect the subject's ability to understand the study procedure.
- Significant psychiatric disturbance that may impair the subject from co-operating with the study procedures.
- Use of acute pain medications on a daily or frequent pattern (for any indication) as defined by the IHS.
Exclusion criteria for control subjects:
- Any other headache diagnosis except for IHS-defined infrequent ETTH.
- Use of any headache preventive drug (determined by investigator) in the 90 days prior to screening.
- Treatment with botulinum toxin (for any indication) within the 90 day period prior to enrollment.
- Treatment with occipital nerve block or block, or block of any other nerve in the head or neck area, within the 30 day period prior to enrollment.
- Any dermatological disease that may affect skin sensation.
- Any neurological disease that may affect sensory functions (e.g stroke, multiple sclerosis, peripheral neuropathy).
- Cognitive disturbance that may affect the subject's ability to understand the study procedure.
- Significant psychiatric disturbance that may impair the subject from co-operating with the study procedures.
- Use of acute pain medications on a daily or frequent pattern (for any indication) as defined by the IHS.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Subjects with episodic migraine with allodynia
These are subjects with episodic migraine with allodynia
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Subjects with episodic migraine without allodynia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine
Time Frame: Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.
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Measurement of phonophobia: determine sound aversion threshold (SAT), measured in dB during a migraine attack in subjects with and in subjects without allodynia.
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Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abraham A. Ashkenazi, M.D., Thomas Jefferson University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
October 11, 2006
First Submitted That Met QC Criteria
October 11, 2006
First Posted (Estimate)
October 12, 2006
Study Record Updates
Last Update Posted (Estimate)
August 22, 2014
Last Update Submitted That Met QC Criteria
August 4, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA-Phono-CA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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