Trigeminal Neuralgia Clinical Trial
— WEC1Official title:
The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
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
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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