NCT02585739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

2.1 years

First QC Date

October 22, 2015

Last Update Submit

October 22, 2015

Conditions

Episodic or Chronic Cluster Headache

Outcome Measures

Primary Outcomes (1)

  • SPINK1 genotyping

    2 months

Study Arms (2)

patient

EXPERIMENTAL

patient with Cluster headache

Genetic: blood sample

healthy subject

OTHER

patient without Cluster headache

Genetic: blood sample

Interventions

blood sampleGENETIC
healthy subjectpatient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • People aged under 18
  • Patient refusing to participate to the research study
  • Patient with deprivation of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHM

Marseille, France

Location

MeSH Terms

Conditions

RecurrenceCluster Headache

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTrigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • urielle desalbres

    APHM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 23, 2015

Study Start

October 1, 2011

Primary Completion

November 1, 2013

Study Completion

July 1, 2015

Last Updated

October 23, 2015

Record last verified: 2015-10

Locations

FR(1)