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NCT Number: NCT02910323

The Will Erwin Headache Research Center - Cluster Headache Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Rebecca Martinez, RN

CONTACT

[email protected]

713-486-7771

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Life expectancy 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 informed consent.

Inclusion criteria

for Healthy Volunteers:

  • Inclusion criteria is willingness to consent and be of age 18 and older

Treatment and study plan

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

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

    Results of GWAS or other genetic tests

  2. Molecular biomarkers

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mark J Burish, MD, PhD

CONTACT

713-486-7771

Rebecca Martinez, RN

CONTACT

[email protected]

713-486-7771

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia

Acronym: WEC1

Important dates

Study start
2016
Primary completion
2035
Study completion
2035
First posted
Sep 22, 2016
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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