Cluster HeadacheNCT00458770
Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks
A study testing position emission transaxial tomography in people with Cluster Headache, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Cluster headache is characterized by unilateral excruciating head pain and autonomic dysfunction. Hypothalamic overactivity was observed in nitrate-induced cluster-headache and in only one case of spontaneous cluster headache 'Sprenger et al, 2004). This prompted the application of hypothalamic deep brain stimulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cluster Headache
- What is being tested?
- position emission transaxial tomography
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to May 2011
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cluster headache in crisis
- no serious illnesses in progress as cancer, autoimmune disease, liver disease
- patient without chronic psychiatric disease excluding moderate and reactional depression
- no demential disease
- no anxious or depressive disease
- no contraindication to PET scan (pregnancy and breast-feeding)
- social security cover
- written informed consent
Who cannot join
- No effective contraception taken
- unable to realize a decubitus of 15 minutes long
Trial locations and contacts
1 site in 1 country.
About this study
Cluster headache is characterized by unilateral excruciating head pain and autonomic dysfunction. Hypothalamic overactivity was observed in nitrate-induced cluster-headache and in only one case of spontaneous cluster headache 'Sprenger et al, 2004). This prompted the application of hypothalamic deep brain stimulation. The aim of this data is to precise the localisation of the hypothalamic activation.
- Conditions
- Cluster Headache
- Being tested
- position emission transaxial tomography
- Keywords
- Comparison of a spontaneous acute cluster headache attack and rest (no pain) in ten patients with cluster headache defined with IHS criteria
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
position emission transaxial tomographyProcedure or surgery
cerebral position emission transaxial tomography using 18Fluorodeoxyglucose
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startMay 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne DONNET, PH, Principal investigator, Pôle de Neurosciences Cliniques CHU Timone, 204 rue St Pierre, Marseille 13385 cedex 5 France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458770
- Sponsor's protocol ID
- 2006/22
- Other IDs
- 2009-A00149-48
- Status last verified
- Feb 2014
- First submitted
- 10 Apr 2007
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks
- ClinicalTrials.gov ID
- NCT00458770
- Acronym / sponsor ID
- 2006/22
- Conditions
- Cluster Headache
- Keywords
- Comparison of a spontaneous acute cluster headache attack and rest (no pain) in ten patients with cluster headache defined with IHS criteria
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Apr 2007 (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.
Cluster headache is characterized by unilateral excruciating head pain and autonomic dysfunction. Hypothalamic overactivity was observed in nitrate-induced cluster-headache and in only one case of spontaneous cluster headache 'Sprenger et al, 2004). This prompted the application of hypothalamic deep brain stimulation. The aim of this data is to precise the localisation of the hypothalamic activation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- cluster headache in crisis
- no serious illnesses in progress as cancer, autoimmune disease, liver disease
- patient without chronic psychiatric disease excluding moderate and reactional depression
- no demential disease
- no anxious or depressive disease
Key exclusion criteria (2 listed)
- No effective contraception taken
- unable to realize a decubitus of 15 minutes long
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 |
|---|---|---|
| position emission transaxial tomographycerebral position emission transaxial tomography using 18Fluorodeoxyglucose | Procedure or surgery | – |
Primary outcome
To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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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.
Anne DONNET, PH principal investigator
Pôle de Neurosciences Cliniques CHU Timone, 204 rue St Pierre, Marseille 13385 cedex 5 France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing position emission transaxial tomography in people with Cluster Headache, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 8 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: stopped early, as of the sponsor's last update on 25 Feb 2014. 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 France. 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 was stopped early. Results are not available in the source record.
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?
To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks (time frame: 2 years). 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 25 Feb 2014.