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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02585739
Other study ID # 2011-19
Secondary ID RC12_3011
Status Completed
Phase N/A
First received October 22, 2015
Last updated October 22, 2015
Start date October 2011
Est. completion date July 2015

Study information

Verified date October 2015
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 (CH) is a rare, excruciating primary headache disorder. A genetic basis has been suggested by family and twin studies, but the mode of transmission seems to vary and the amount of heritability is unclear.

The number of genetic association studies investigating variants implicated in the pathophysiology of CH is limited. The HCRTR2 1246G > A and the ADH4 925A > G polymorphisms have been associated with CH. The former has been confirmed and may affect the hypothalamic hypocretin system. The aim of the present study was to investigate the possible link between SPINK 1 gene and cluster headache.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date July 2015
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- People aged 18 or over

- Patient consulting in Marseille's or Nice's Pain departments

- Patient agreeing to participate to the research study

- Patient with health insurance

Exclusion Criteria:

- People aged under 18

- Patient refusing to participate to the research study

- Patient with deprivation of liberty

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Genetic:
blood sample


Locations

Country Name City State
France APHM 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 SPINK1 genotyping 2 months No