MigraineNCT00329771
Research Study to Determine Sensitivity to Gentle Touch and Pressure During an Active Migraine Attack.
An observational study of Migraine, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a heightened skin sensitivity during an active migraine attack. Migraine attacks in patients who experience allodynia are more difficult to treat. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with episodic migraine, as defined by the International Headache Society,recruited from our office practice and the communitiy
Who may be able to join
- Male and female patients aged 18-65, inclusive
- Diagnosis of episodic migraine with or without aura.
- Ability to read and understand an informed consent form and study procedures
Who cannot join
- Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
- Patients who suffer from headache (of any type) 15 or more days per month
- Patients who are cognitively impaired, as determined by investigator
- Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
- Patients who had taken any acute pain medication (e.g. triptans, ergots, NSAIDs, opioids, butalbital, acetaminophen) for any indication within 12 hours prior to allodynia testing.
- Patients with skin diseases that may cause abnormal skin sensation.
- Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
About this study
Official title: Brush Allodynia in Patients With Episodic Migraine During an Acute Attack.
Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a heightened skin sensitivity during an active migraine attack. Migraine attacks in patients who experience allodynia are more difficult to treat. This study intends to collect and evaluate data on the phenomenon of allodynia in patients with episodic migraine during an actual attack. The results of this study may help clinicians better understand allodynia, thereby helping them diagnose and more effectively manage patients with migraine and allodynia.
- Conditions
- Migraine
- Being tested
- No intervention: We are testing for the presence of allodynia
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention: We are testing for the presence of allodyniaOther
We are testing for the presence of abnormal sensation (allodynia) during a migraine attack.
| Study group | Role | What they receive |
|---|---|---|
| Episodic migraineurs | Eligible subjects with episodic migraine (with or without aura) Receives: Other: No intervention: We are testing for the presence of allodynia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With Allodynia During a Migraine Attack
Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS). After each series of brushes the patient will be asked to rate the level of discomfort from "normal sensation" to "extremely painful or unpleasant" using a 100 mm visual analog scale (VAS).
Measured: allodynia assessed within 4 hours from onset of migraine head pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abraham A Ashkenazi, M.D., Principal investigator, Jefferson Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329771
- Sponsor's protocol ID
- EM-BA/AAA
- Status last verified
- Mar 2024
- First submitted
- 24 May 2006
- Last updated
- 27 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brush Allodynia in Patients With Episodic Migraine During an Acute Attack.
- ClinicalTrials.gov ID
- NCT00329771
- Acronym / sponsor ID
- EM-BA/AAA
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 25 May 2006 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a heightened skin sensitivity during an active migraine attack. Migraine attacks in patients who experience allodynia are more difficult to treat. This study intends to collect and evaluate data on the phenomenon of allodynia in patients with episodic migraine during an actual attack. The results of this study may help clinicians better understand allodynia, thereby helping them diagnose and more effectively manage patients with migraine and allodynia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Episodic migraineurs | – | Other: No intervention: We are testing for the presence of allodyniaEligible subjects with episodic migraine (with or without aura) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with episodic migraine, as defined by the International Headache Society,recruited from our office practice and the communitiy
Key inclusion criteria (3 listed)
- Male and female patients aged 18-65, inclusive
- Diagnosis of episodic migraine with or without aura.
- Ability to read and understand an informed consent form and study procedures
Key exclusion criteria (7 listed)
- Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
- Patients who suffer from headache (of any type) 15 or more days per month
- Patients who are cognitively impaired, as determined by investigator
- Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
- Patients who had taken any acute pain medication (e.g. triptans, ergots, NSAIDs, opioids, butalbital, acetaminophen) for any indication within 12 hours prior to allodynia testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention: We are testing for the presence of allodyniaWe are testing for the presence of abnormal sensation (allodynia) during a migraine attack. | Other | Episodic migraineurs |
Primary outcome
Proportion of Subjects With Allodynia During a Migraine Attack
Time frame: allodynia assessed within 4 hours from onset of migraine head pain
Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS). After each series of brushes the patient will be asked to rate the level of discomfort from "normal sensation" to "extremely painful or unpleasant" using a 100 mm visual analog scale (VAS).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Migraine
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
RecruitingObservational study
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Migraine
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham A Ashkenazi, M.D. principal investigator
Jefferson Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects With Allodynia During a Migraine Attack (time frame: allodynia assessed within 4 hours from onset of migraine head pain). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.