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RecruitingNCT02910323WEC1Updated Feb 18, 2026

The Will Erwin Headache Research Center - Cluster Headache Study

An observational study in Cluster Headache, Cluster Headaches and Other Trigeminal Autonomic Cephalgias and Paroxysmal Hemicrania, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by The University of Texas Health Science Center, Houston · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study summary

The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia is a prospective, multicenter, observational research network for subjects with Cluster Headache and/or Trigeminal Neuralgia.

Read the detailed description

The Will Erwin Headache Research Center will assemble a national registry of Cluster Headache patients and will sub-categorize and organize this cohort based on individuating characteristics including but not limited to type and severity of condition, associated symptoms, and medical/psychological issues (e.g., depression, disability, sleep). Detailed evaluations and classification will be completed for each enrolled subject. This will encompass genomic and epigenomic studies, past medical history, imaging reports, and specific physical exam results for each patient. It will also enable the study investigators to match patients with suitable interventional clinical trials.

Similar diseases, such as other paroxysmal hemicrania, SUNCT, SUNA, hemicrania continua, and trigeminal neuralgia may also be investigated.

02

Conditions studied

  • Cluster Headache
  • Cluster Headaches and Other Trigeminal Autonomic Cephalgias
  • Paroxysmal Hemicrania
  • SUNCT
  • Hemicrania Continua
  • Trigeminal Neuralgia
03

In context

Cluster Headache

123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 68 across 32 observational studies indexed under Cluster Headache.

Browse Cluster Headache studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Cluster Headache and Trigeminal Neuralgia patients, family members and healthy volunteers

Eligibility criteria

Inclusion Criteria:

  • Diagnosis of a trigeminal autonomic cephalalgia according to the International Headache Classification including episodic cluster headache, chronic cluster headache, episodic paroxysmal hemicrania, chronic paroxysmal hemicrania, episodic short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT), chronic SUNCT, episodic short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA), chronic SUNA, and hemicrania continua. OR Diagnosis of a trigeminal neuralgia according to the International Headache Classification, including classical trigeminal neuralgia and symptomatic trigeminal neuralgia.
  • Able to provide HIPAA authorization to share prior medical records/imaging.

Exclusion Criteria:

  • less than 1 year, co-existing disease or other characteristic that precludes appropriate diagnosis of a trigeminal autonomic cephalalgia or trigeminal neuralgia.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Inability or unwillingness of subject or legal guardian/representative to give .

Inclusion Criteria for Healthy Volunteers:

  • Inclusion criteria is willingness to consent and be of age 18 and older
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Experimental group

    Patients with a history of Cluster Headaches and other TACs, or Trigeminal Neuralgia.

  • Family/Healthy Controls

    Healthy volunteer controls and family members may be enrolled for identification of genetic mutations.

06

What researchers measure

Primary outcomes

  1. HIT-6 scale

    Time frame: Through study completion, an average of 5 years

  2. Morningness-eveningness scale

    Time frame: Through study completion, an average of 5 years

  3. GAD-7 scale

    Time frame: Through study completion, an average of 5 years

Secondary outcomes

  1. Genetic markers

    Results of GWAS or other genetic tests

    Time frame: Through study completion, an average of 5 years

  2. Molecular biomarkers

    Results of ELISAs for autonomic, hypothalamic, and pain signalling molecules

    Time frame: Through study completion, an average of 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available. PubMed 23771276 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2016, a primary completion of Dec 2035 and a completion of Dec 2035. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2016
First posted
Sep 22, 2016
Start
Jul 12, 2016
Primary completionEst.
Dec 2035
CompletionEst.
Dec 2035
Last update
Feb 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02910323
Responsible party
Mark J Burish (Assistant Professor, Neurosurgery, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Sep 22, 2016
Start date
Jul 12, 2016
Primary completion
Dec 2035 (estimated)
Completion
Dec 2035 (estimated)
Last update
Feb 18, 2026

Study contacts

Rebecca Martinez, RN
Contact
nctt.wec@uth.tmc.edu
713-486-7771
Mark J Burish, MD, PhD
Contact
713-486-7771
Mark Burish, MD, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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