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The Will Erwin Headache Research Center - Cluster Headache Study (WEC1)

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ClinicalTrials.gov Identifier: NCT02910323
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Mark J Burish, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date September 15, 2016
First Posted Date September 22, 2016
Last Update Posted Date November 9, 2020
Study Start Date May 2016
Estimated Primary Completion Date December 2035   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 19, 2016)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 19, 2016)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Will Erwin Headache Research Center - Cluster Headache Study
Official Title The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia
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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine, saliva, skin cells, other
Sampling Method Non-Probability Sample
Study Population Cluster Headache and Trigeminal Neuralgia patients, family members and healthy volunteers
Condition
  • Cluster Headache
  • Cluster Headaches and Other Trigeminal Autonomic Cephalgias
  • Paroxysmal Hemicrania
  • SUNCT
  • Hemicrania Continua
  • Trigeminal Neuralgia
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 19, 2016)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2035
Estimated Primary Completion Date December 2035   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Rebecca Martinez, RN 713-486-7771 nctt.wec@uth.tmc.edu
Contact: Mark J Burish, MD, PhD 713-486-7771
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02910323
Other Study ID Numbers HSC-MS-15-0780
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Mark J Burish, The University of Texas Health Science Center, Houston
Study Sponsor The University of Texas Health Science Center, Houston
Collaborators Not Provided
Investigators
Principal Investigator: Mark Burish, MD, PhD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date November 2020