NCT02640105

Brief Summary

Cluster headache (CH) is one of the most painful primitive headaches. Developments in neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic system, which is similar in patients with addictions. CH has strong links to the vascular system but there is no study measuring endothelial function in CH sufferers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

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

June 25, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2016

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

November 23, 2015

Last Update Submit

March 30, 2022

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (8)

  • Duration of active periods of cluster headache

    Day 0 (Inclusion visit)

  • Number of active periods

    Day 0 (Inclusion visit)

  • Duration of cluster headache

    Day 0 (Inclusion visit)

  • Severity of attacks

    Day 0 (Inclusion visit)

  • Duration of active periods of cluster headache

    one year after inclusion

  • Number of active periods

    one year after inclusion

  • Duration of cluster headache

    one year after inclusion

  • Severity of attacks

    one year after inclusion

Secondary Outcomes (5)

  • Existence of an addiction

    Day 0 (Inclusion visit)

  • Existence of an addiction

    One year after inclusion

  • Severity of Addiction

    Day 0 (Inclusion visit)

  • Severity of Addiction

    One year after inclusion

  • Reactive Hyperemic Index (RHI)

    Day 0 (Inclusion visit)

Study Arms (1)

Patient with Cluster headache

Prospective follow-up of patient with Cluster headache

Other: Neurological clinical examinationOther: Psychological clinical examinationOther: QuestionnairesOther: Blood sampleOther: Endothelial function measurement

Interventions

Neurological clinical examinationOTHER

Diagnostic and description of cluster headache

Patient with Cluster headache
Psychological clinical examinationOTHER

Scale and questionnaires

Patient with Cluster headache
QuestionnairesOTHER

Psychopathological and cognitive questionnaires

Patient with Cluster headache
Blood sampleOTHER

Blood sample for DNA collection

Patient with Cluster headache
Endothelial function measurementOTHER

Endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device

Patient with Cluster headache

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with cluster headache

You may qualify if:

  • Presenting a chronic or episodic cluster headache diagnosed according to the International Classification of Headache Disorders (ICH-D III) criteria, in active or inactive phase.

You may not qualify if:

  • Other primary headaches
  • Subjects without social insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Cluster Headache

Interventions

Surveys and QuestionnairesBlood Specimen Collection

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2015

First Posted

December 28, 2015

Study Start

June 25, 2014

Primary Completion

June 10, 2016

Study Completion

June 10, 2016

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

FR(1)