Cluster Headache and SPINK-1 Gene

October 22, 2015 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • APHM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient
patient with Cluster headache
Genetic: blood sample
Other: healthy subject
patient without Cluster headache
Genetic: blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SPINK1 genotyping
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Estimate)

October 23, 2015

Last Update Submitted That Met QC Criteria

October 22, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-19
  • RC12_3011 (Other Identifier: APHM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Episodic or Chronic Cluster Headache

Clinical Trials on blood sample

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe