Recruiting

Cluster Headache

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT02910323

Conditions

Cluster Headache

Cluster Headaches and Other Trigeminal Autonomic Cephalgias

Paroxysmal Hemicrania

SUNCT

Hemicrania Continua

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Cluster Headache

Cluster Headaches and Other Trigeminal Autonomic Cephalgias

Paroxysmal Hemicrania

SUNCT

Hemicrania Continua

Study ID

NCT02910323

Start date

Jul 12, 2016

Status verified date

Feb, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • HIT-6 scale [ Time Frame: Through study completion, an average of 5 years ]
  • Morningness-eveningness scale [ Time Frame: Through study completion, an average of 5 years ]
  • GAD-7 scale [ Time Frame: Through study completion, an average of 5 years ]

Central Contacts and Locations

Central contacts

Rebecca Martinez, RN

713-486-7771nctt.wec@uth.tmc.edu

Mark J Burish, MD, PhD

713-486-7771

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Rebecca Martinez, RN

713-486-7771nctt.wec@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-02-18.