MigraineNCT00335803
A Research Study To Compare Two Kinds Of Daily Headache
An observational study of Migraine, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Chronic daily headache has been classified into several categories. One category is of sudden onset and is called New Daily Persistent Headache (NDPH). Another category of daily headache evolves gradually and is called Transformed Migraine (TM). Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Migraine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients aged 14-65, inclusive
- Diagnosis of NDPH or TM according to the Silberstein-Lipton criteria.
- Ability to read and understand an informed consent form and study procedures
Who cannot join
- Pregnancy
- Subjects with any disease or condition that would result in unreliable data or confound the data obtained for this study, as determined by the principal investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Comparison Of Subjects With New Daily Persistent Headache (NDPH) And Subjects With Transformed Migraine (TM)
Chronic daily headache has been classified into several categories. One category is of sudden onset and is called New Daily Persistent Headache (NDPH). Another category of daily headache evolves gradually and is called Transformed Migraine (TM). This research study is being conducted to compare people with these two kinds of daily headache in order to improve our understanding of these conditions.
- Conditions
- Migraine
- Medical subject headings
- Migraine Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startMar 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Investigators
- william b young, M.D., Principal investigator, Jefferson Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335803
- Sponsor's protocol ID
- WBY/NDPH-TM/001
- Status last verified
- Jan 2009
- First submitted
- 9 Jun 2006
- Last updated
- 23 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Of Subjects With New Daily Persistent Headache (NDPH) And Subjects With Transformed Migraine (TM)
- ClinicalTrials.gov ID
- NCT00335803
- Acronym / sponsor ID
- WBY/NDPH-TM/001
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic daily headache has been classified into several categories. One category is of sudden onset and is called New Daily Persistent Headache (NDPH). Another category of daily headache evolves gradually and is called Transformed Migraine (TM). This research study is being conducted to compare people with these two kinds of daily headache in order to improve our understanding of these conditions.
Study design
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients aged 14-65, inclusive
- Diagnosis of NDPH or TM according to the Silberstein-Lipton criteria.
- Ability to read and understand an informed consent form and study procedures
Key exclusion criteria (2 listed)
- Pregnancy
- Subjects with any disease or condition that would result in unreliable data or confound the data obtained for this study, as determined by the principal investigator.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
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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.
william b young, 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 2 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 23 Jan 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 23 Jan 2009.