The Will Erwin Headache Research Center - Cluster Headache Study (WEC1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02910323|
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : November 9, 2020
|Condition or disease|
|Cluster Headache Cluster Headaches and Other Trigeminal Autonomic Cephalgias Paroxysmal Hemicrania SUNCT Hemicrania Continua Trigeminal Neuralgia|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2035|
|Estimated Study Completion Date :||December 2035|
Patients with a history of Cluster Headaches and other TACs, or Trigeminal Neuralgia.
Healthy volunteer controls and family members may be enrolled for identification of genetic mutations.
- 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 ]
- Genetic markers [ Time Frame: Through study completion, an average of 5 years ]Results of GWAS or other genetic tests
- Molecular biomarkers [ Time Frame: Through study completion, an average of 5 years ]Results of ELISAs for autonomic, hypothalamic, and pain signalling molecules
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910323
|Contact: Rebecca Martinez, RNfirstname.lastname@example.org|
|Contact: Mark J Burish, MD, PhD||713-486-7771|
|United States, Texas|
|The University of Texas Health Science Center at Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Rebecca Martinez, RN 713-486-7771 email@example.com|
|Principal Investigator:||Mark Burish, MD, PhD||The University of Texas Health Science Center, Houston|