Chronic Daily HeadacheNCT00880425
Do Patients With Chronic Daily Headache Have Continuous Headache or Moments of Headache Relief?
An observational study of Chronic Daily Headache, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The objective of this study is to determine if patients with chronic daily headache have continuous headache or moments of headache relief. The secondary objective of this study is to determine the period of time patients who have chronic daily headache that is not continuous are headache free. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Daily Headache
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Headache clinic patients with diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Tension type headache, or chronic post traumatic headache, over age 18.
Who may be able to join
- Patients with Chronic Migraine, New Daily Persistent Headache, Chronic Tension type headache, or chronic post traumatic headache seen at the Jefferson Headache Center.
Who cannot join
- Subjects under age 18.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine if patients with chronic daily headache have continuous headache or moments of headache relief. The secondary objective of this study is to determine the period of time patients who have chronic daily headache that is not continuous are headache free.
Read the detailed description
This study is a retrospective chart review of all patients over the age of 18 who are seen by the co-investigator during one initial, or routine follow up visit, with the diagnosis of chronic migraine, chronic tension type headache, new daily persistent headache, or chronic post traumatic headache(per International Headache Classification II guidelines6). Patients with the above diagnosis during their routine care are asked five standard questions about their headaches by the co-investigator, and the responses are recorded in the patient's medical record (see question sheet attached). These questions pertain to the patients' health care, and are asked of most patients at the Jefferson Headache center with chronic headache routinely during office visits.
- Conditions
- Chronic Daily Headache
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with continuous headache | Not described | |
| Participants with non-continuous headache | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Daily Headache Who Have Continuous Headache
Measured: Records were reviewed from April 2009 through June 2009
Secondary outcomes (1)
Number of Patient With Daily Headache Who Have Non-continuous Headache
Measured: Records were reviewed from April 2009 through June 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJul 2009
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 Chronic Daily HeadacheStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 45 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
- Stephen D Silberstein, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880425
- Sponsor's protocol ID
- SDS/CDH/01
- Status last verified
- Feb 2025
- First submitted
- 10 Apr 2009
- 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
- Do Patients With Chronic Daily Headache Have Continuous Headache or Moments of Headache Relief?
- ClinicalTrials.gov ID
- NCT00880425
- Acronym / sponsor ID
- SDS/CDH/01
- Conditions
- Chronic Daily Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Posted 29 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if patients with chronic daily headache have continuous headache or moments of headache relief. The secondary objective of this study is to determine the period of time patients who have chronic daily headache that is not continuous are headache free.
Detailed description
This study is a retrospective chart review of all patients over the age of 18 who are seen by the co-investigator during one initial, or routine follow up visit, with the diagnosis of chronic migraine, chronic tension type headache, new daily persistent headache, or chronic post traumatic headache(per International Headache Classification II guidelines6). Patients with the above diagnosis during their routine care are asked five standard questions about their headaches by the co-investigator, and the responses are recorded in the patient's medical record (see question sheet attached). These questions pertain to the patients' health care, and are asked of most patients at the Jefferson Headache center with chronic headache routinely during office visits.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with continuous headache | – | – |
| Participants with non-continuous headache | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Headache clinic patients with diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Tension type headache, or chronic post traumatic headache, over age 18.
Key inclusion criteria (1 listed)
- Patients with Chronic Migraine, New Daily Persistent Headache, Chronic Tension type headache, or chronic post traumatic headache seen at the Jefferson Headache Center.
Key exclusion criteria (1 listed)
- Subjects under age 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Subjects With Daily Headache Who Have Continuous Headache
Time frame: Records were reviewed from April 2009 through June 2009
1 secondary outcome
Number of Patient With Daily Headache Who Have Non-continuous Headache
Time frame: Records were reviewed from April 2009 through June 2009
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.
Stephen D Silberstein, MD principal investigator
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 Chronic Daily 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 1 inclusion and 1 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 29 Oct 2010). 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?
Number of Subjects With Daily Headache Who Have Continuous Headache (time frame: Records were reviewed from April 2009 through June 2009). 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.