Cluster Headache Treatment Survey | NCT06011811

Studies
Cluster Headache Treatment Survey

NCT06011811

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Feb 18, 2026Actual

Enrollment

2,487Actual

Phase

Not provided

Conditions

Cluster Headache

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2023Actual

Primary Completion Date

Jun 28, 2025Actual

Completion Date

Jun 28, 2025Actual

First Submitted Date

Aug 19, 2023

First Submission Date that Met QC Criteria

Aug 23, 2023

First Posted Date

Aug 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2026

Last Update Posted Date

Feb 18, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mark J Burish, Associate Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Name	Class
Clusterbusters, Inc.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to survey patients with cluster headache about treatment effectiveness and their views on treatments. Participants will complete one brief questionnaire online.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,487Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with episodic or chronic cluster headache		Patients with a diagnosis of episodic or chronic cluster headache, as diagnosed by a health care professional and to be confirmed by questions on the study survey.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness of cluster headache treatment as assessed by a survey		at the time of survey completion, expected to be 6-12 months

Secondary Outcomes

Measure	Description	Time Frame
Opinions on new cluster headache treatment as assessed by a survey		at the time of survey completion, expected to be 6-12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with episodic or chronic cluster headache that has been diagnosed by a health care professional (no documentation is needed, participant must simply state that he or she has been diagnosed)

Exclusion Criteria:

Unable to speak English (the survey is only in English)
Unable to use a computer to take the online survey
Unable to provide consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The population is patients with episodic or chronic cluster headache that has been diagnosed by a health care professional. The cluster headache diagnosis will be verified via the survey using a validated cluster headache diagnostic screen.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark J Burish, MD, PhD	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center at Houston		Houston	Texas	77030	United States

Label	URL
Link to study survey	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003027	Cluster Headache

Ancestor Terms

ID	Term
D051303	Trigeminal Autonomic Cephalalgias
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided