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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00458770
Other study ID # 2006/22
Secondary ID 2009-A00149-48
Status Terminated
Phase N/A
First received April 10, 2007
Last updated February 24, 2014
Start date May 2009
Est. completion date May 2011

Study information

Verified date February 2014
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical 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. The aim of this data is to precise the localisation of the hypothalamic activation.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- No effective contraception taken

- unable to realize a decubitus of 15 minutes long

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Procedure:
position emission transaxial tomography
cerebral position emission transaxial tomography using 18Fluorodeoxyglucose

Locations

Country Name City State
France Pôle de Neurosciences Cliniques CHU Timone Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks 2 years No
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