The Will Erwin Headache Research Center - Cluster Headache Study

Trigeminal Neuralgia Clinical Trial

— WEC1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02910323
• Other study ID #: HSC-MS-15-0780
• Status: Recruiting
• Start date: May 2016
• Est. completion date: December 2035

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Rebecca Martinez, RN
• Phone: 713-486-7771
• Email: nctt.wec[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2035
• Est. primary completion date: December 2035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIT-6 scale		Through study completion, an average of 5 years
Primary	Morningness-eveningness scale		Through study completion, an average of 5 years
Primary	GAD-7 scale		Through study completion, an average of 5 years
Secondary	Genetic markers	Results of GWAS or other genetic tests	Through study completion, an average of 5 years
Secondary	Molecular biomarkers	Results of ELISAs for autonomic, hypothalamic, and pain signalling molecules	Through study completion, an average of 5 years