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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02910323
Other study ID # HSC-MS-15-0780
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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