Back to resultsCluster Headache and SPINK-1 Gene
Primary Purpose
Episodic or Chronic Cluster Headache
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional screening trial for Episodic or Chronic Cluster Headache
Eligibility Criteria
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
Sites / Locations
- APHM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
patient
healthy subject
Arm Description
patient with Cluster headache
patient without Cluster headache
Outcomes
Primary Outcome Measures
SPINK1 genotyping
Secondary Outcome Measures
Full Information
NCT ID
NCT02585739
First Posted
October 22, 2015
Last Updated
October 22, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02585739
Brief Title
Cluster Headache and SPINK-1 Gene
Official Title
Cluster Headache and SPINK-1 Gene
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic or Chronic Cluster Headache
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient
Arm Type
Experimental
Arm Description
patient with Cluster headache
Arm Title
healthy subject
Arm Type
Other
Arm Description
patient without Cluster headache
Intervention Type
Genetic
Intervention Name(s)
blood sample
Primary Outcome Measure Information:
Title
SPINK1 genotyping
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
urielle desalbres
Organizational Affiliation
APHM
Official's Role
Study Director
Facility Information:
Facility Name
APHM
City
Marseille
Country
France
12. IPD Sharing Statement
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Cluster Headache and SPINK-1 Gene
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