Cluster HeadacheNCT00329836
A Research Study to Examine Cutaneous Allodynia and Cluster Headache
An observational study of Cluster Headache, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cluster Headache
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with cluster headache
Who may be able to join
- Male and female patients aged 18-75, inclusive
- Diagnosis of cluster headache, episodic or chronic.
- Patients with episodic CH can be either in active cluster period or not.
- Ability to read and understand an informed consent form, where the study protocol is described.
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 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 an acute pain medication within 24 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/ Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Many studies have been performed looking at the presence of cutaneous allodynia in patients with migraines; however, few studies have examined it in cluster headache patients. There is still much to be learned about the brain and how it functions if the investigators are to understand the underlying causes of cluster headache. It is important to explore cutaneous allodynia in cluster headache as it may help guide physicians with the care of these individuals. Sixty patients will be screened for this study. Thomas Jefferson University is the only center enrolling patients in this research study.
- Conditions
- Cluster Headache
- Being tested
- There are no interventions in the observational study. The symptom of allodynia was measured.
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There are no interventions in the observational study. The symptom of allodynia was measured.Other
No intervention. Description of allodynia testing appears elsewhere in this document
| Study group | Role | What they receive |
|---|---|---|
| Subjects with cluster headache | Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled. Receives: Other: There are no interventions in the observational study. The symptom of allodynia was measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Allodynia in Subjects With Cluster Headache
Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.
Measured: Allodynia was assessed at the screening visit
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 startAug 2006
- Primary completionFeb 2008
- Study completionFeb 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 Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen D. Silberstein, Thomas Jefferson University
- Investigators
- Abraham A. Ashkenazi, M.D., Principal investigator, Jefferson Headache Center/ thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329836
- Sponsor's protocol ID
- CA/CH/01
- Status last verified
- Feb 2025
- First submitted
- 24 May 2006
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research Study to Examine Cutaneous Allodynia and Cluster Headache
- ClinicalTrials.gov ID
- NCT00329836
- Acronym / sponsor ID
- CA/CH/01
- Conditions
- Cluster Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 25 May 2006 (estimated)
- Results
- Posted 16 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Many studies have been performed looking at the presence of cutaneous allodynia in patients with migraines; however, few studies have examined it in cluster headache patients. There is still much to be learned about the brain and how it functions if the investigators are to understand the underlying causes of cluster headache. It is important to explore cutaneous allodynia in cluster headache as it may help guide physicians with the care of these individuals. Sixty patients will be screened for this study. Thomas Jefferson University is the only center enrolling patients in this research study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with cluster headache | – | Other: There are no interventions in the observational study. The symptom of allodynia was measured.Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with cluster headache
Key inclusion criteria (4 listed)
- Male and female patients aged 18-75, inclusive
- Diagnosis of cluster headache, episodic or chronic.
- Patients with episodic CH can be either in active cluster period or not.
- Ability to read and understand an informed consent form, where the study protocol is described.
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 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 an acute pain medication within 24 hours prior to allodynia testing.
- Patients with skin diseases that may cause abnormal skin sensation.
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 |
|---|---|---|
| There are no interventions in the observational study. The symptom of allodynia was measured.No intervention. Description of allodynia testing appears elsewhere in this document | Other | Subjects with cluster headache |
Primary outcome
Prevalence of Allodynia in Subjects With Cluster Headache
Time frame: Allodynia was assessed at the screening visit
Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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/ thomas Jefferson University
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 Cluster Headache, 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 4 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 28 Feb 2025. 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 16 Aug 2011). 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?
Prevalence of Allodynia in Subjects With Cluster Headache (time frame: Allodynia was assessed at the screening visit). 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 28 Feb 2025.