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Trial record 12 of 32 for:    Recruiting Studies | Huntington Disease

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease (HDClarity)

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ClinicalTrials.gov Identifier: NCT02855476
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
HDClarity will seek to enroll approximately 600 research participants - 500 of whom will be at different stages of Huntington's disease (HD) and 100 healthy controls. The primary objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD. The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development.

Condition or disease
Huntington's Disease

Detailed Description:
All participants will attend a screening and sampling visit. During the screening visit, medical history, and clinical and phenotypic data will be obtained. Participants who meet the eligibility requirements are willing to continue in the study, will return for a sampling visit during which ≤20ml CSF and approximately 50ml blood will be collected following an overnight fast: blood will be obtained via venipuncture and CSF will be obtained via lumbar puncture using local anaesthetic if required. Approximately 120 participants (including 20 controls) will be invited to attend an optional repeat sampling visit 4-6 weeks after the original sampling visit.

Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
Actual Study Start Date : January 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Early Pre-manifest HD
Huntington's disease gene expansion carriers who not have clinical diagnostic motor features of HD
Late Pre-manifest HD
Huntington's disease gene expansion carriers who not have clinical diagnostic motor features of HD, but who have a higher burden of disease compared to the Early Pre-manifest HD cohort
Early Manifest HD
Huntington's disease gene expansion carriers who have clinical diagnostic motor features of HD defined as Stage I or Stage II HD
Moderate Manifest HD
Huntington's disease gene expansion carriers who have clinical diagnostic motor features of HD defined as Stage III HD
Late Manifest HD
Huntington's disease gene expansion carriers who have clinical diagnostic motor features of HD defined as Stage IV-V HD
Controls
Have no known family history of HD; or have known family history of HD but have been tested for the huntingtin gene glutamine codon (CAG) expansion and are not at genetic risk for HD.


Outcome Measures

Primary Outcome Measures :
  1. Number of CSF samples banked [ Time Frame: Up to 3 years ]
    The primary aim of HDClarity is the generation of a CSF sample repository to facilitate therapeutic development for HD.


Secondary Outcome Measures :
  1. Huntingtin protein level in cerebrospinal fluid [ Time Frame: Up to 3 years ]
    The concentration of mutant and total huntingtin level in CSF will be quantified and its relationship to disease severity assessed

  2. Kynurenine metabolites in cerebrospinal fluid [ Time Frame: Up to 3 years ]
    The concentration of metabolites of the kynurenine pathway in CSF will be quantified and their relationship to disease severity assessed


Biospecimen Retention:   Samples Without DNA
CSF, serum, plasma (participant DNA available via Enroll-HD)

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A total of 600 male and female participants, aged between 21 and 75 years, inclusive, will be enrolled in the study. Eligible participants include healthy controls, people who are in the early pre-manifest and late pre-manifest stage of HD, and people diagnosed with early HD, moderate HD or advanced HD.
Criteria

Inclusion Criteria:

  1. All eligible participants

    1. Are 21-75 years of age, inclusive; and
    2. Are capable of providing informed consent or have a legal representative authorized to give consent on behalf of the participant; and
    3. Are capable of complying with study procedures, including fasting, blood sampling and lumbar puncture; and
    4. Are participating in the Enroll-HD study; and
    5. Will have had an Enroll-HD visit within three months of the Sampling Visit.
  2. For the Early Pre-manifest HD group, participants eligible are persons who meet the following criteria:

    1. Do not have clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score < 4; and
    2. Have CAG expansion ≥ 40; and
    3. Have burden of pathology score, computed as (CAG - 35.5) × age, < 250.
  3. For the Late Pre-manifest HD group, participants eligible are persons who meet the following criteria:

    1. Do not have clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score < 4; and
    2. Have CAG expansion ≥ 40; and
    3. Have burden of pathology score, computed as (CAG - 35.5) x age, ≥ 250.
  4. For Early Manifest HD group, participants eligible are persons who meet the following criteria:

    1. Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
    2. Have CAG expansion ≥ 36; and
    3. Have Stage I or Stage II HD, defined as UHDRS Total Functional Capacity (TFC) scores between 7 and 13 inclusive.
  5. For Moderate Manifest HD group, participants eligible are persons who meet the following criteria:

    1. Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
    2. Have CAG expansion ≥ 36; and
    3. Have Stage III HD, defined as UHDRS TFC scores between 4 and 6, inclusive.
  6. For Advanced Manifest HD group, participants eligible are persons who meet the following criteria:

    1. Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
    2. Have CAG expansion ≥ 36; and
    3. Have Stage IV HD, defined as UHDRS TFC scores between 0 and 3, inclusive.
  7. For the Healthy Control group, subjects eligible are persons who meet the following criteria:

    1. Have no known family history of HD; or
    2. Have known family history of HD but have been tested for the huntingtin gene glutamine codon (CAG) expansion and are not at genetic risk for HD (CAG < 36).

Exclusion Criteria:

1. For all groups, participants are ineligible if they meet any of the following exclusion criteria:

  1. Current use of investigational drugs or participation in a clinical drug trial within 30 days prior to Sampling Visit; or
  2. Current intoxication, drug or alcohol abuse or dependence; or
  3. If using any antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to treat HD, the use of inappropriate (e.g., non-therapeutically high) or unstable dose within 30 days prior to Sampling Visit; or
  4. Significant medical, neurological or psychiatric co-morbidity likely, in the judgment of the Site Principal Investigator, to impair participant's ability to complete study procedures; or
  5. Needle phobia, frequent headache, significant lower spinal deformity or major surgery; or
  6. Antiplatelet or anticoagulant therapy within the 14 days prior to sampling visit, including but not limited to: aspirin, clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban and apixaban; or
  7. Clotting or bruising disorder; or
  8. Screening blood test results outside the lab's normal range for the following: white cell count, neutrophil count, lymphocyte count, hemoglobin (Hb), platelets, prothrombin time (PT) and activated partial thromboplastin time (APTT); or
  9. Screening blood test results for C-reactive protein (CRP)>2× upper limit of normal; or
  10. Predictable non-compliance as assessed by Site Principal Investigator; or
  11. Inability or unwillingness to undertake any of the study procedures; or
  12. Exclusion during history or physical examination, final decision to be made by the Site Principal Investigator; including but not limited to: any reason to suspect abnormal bleeding tendency, e.g. easy bruising, petechial rash; or any reason to suspect new focal neurological lesion, e.g. new headache, optic disc swelling, asymmetric focal long tract signs; or any other reason that, in the clinical judgment of the operator or the Site Principal Investigator, it is felt that lumbar puncture is unsafe without brain imaging.
Contacts and Locations

Information from the National Library of Medicine

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): NCT02855476


Contacts
Contact: Stefanie Gosling, BSc +44 203 108 7482 hdclarity-cc@enroll-hd.org
Contact: Gail Owen, PhD +44 1273 640 688 g.owen@ucl.ac.uk

Locations
United States, Maryland
John Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kia Ultz    410-955-1349    kcarte23@jhmi.edu   
Principal Investigator: Jee Bang, MPH, MD         
Canada, British Columbia
University of British Columbia, The Centre for Huntingtons Disease Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Tuan Le    604-822-4872    tle@cmmt.ubc.ca   
Principal Investigator: Blair Leavitt, MD, CM         
Canada, Ontario
Centre for Movement Disorders Recruiting
Toronto, Ontario, Canada, M3B 2S7
Contact: Teena Kailasanathan    416-847-7084 ext 235    tkailasanathan@movementdisorders.ca   
Principal Investigator: Mark Guttman, MD, FRCPC         
Germany
University Hospital Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Contact: Sonja Trautmann    +49 731 50063023    sonja.trautmann@uni-ulm.de   
Principal Investigator: Jan Lewerenz, MD         
St Josef And Elisabeth Hospital Recruiting
Bochum, Germany
Contact: Barbara Kaminski       b.kaminski@klinikum-bochum.de   
Principal Investigator: Carsten Saft         
United Kingdom
Glasgow Clinical Research Facility Recruiting
Glasgow, Scotland, United Kingdom, G51 4TF
Contact: Scott Farmer    0141 232 7600    Scott.Farmer@ggc.scot.nhs.uk   
Principal Investigator: Stuart Ritchie, Mb, ChB, MRCPsych         
Birmingham Huntingtons Disease Clinic Recruiting
Birmingham, West Midlands, United Kingdom, B15 2 FG
Contact: Jennifer De Souza       Jennifer.DeSouza@bsmhft.nhs.uk   
Principal Investigator: Hugh Rickards, MB, ChB, MSc, FRCPsych, MD         
Leeds Teaching Hospital Trust Recruiting
Leeds, United Kingdom, LS7 4SA
Contact: Callum Schofield    0113 39 24679    callum.schofield@nhs.net   
Principal Investigator: Emma Hobson, MRCP         
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Edward J Wild, MA, MB BChir, MRCP, PhD University College, London
More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Informed Consent Form  This link exits the ClinicalTrials.gov site
Draft informed consent form, not yet approved by an Institutional Review Board for clinical use

Responsible Party: Edward Wild, Dr, University College, London
ClinicalTrials.gov Identifier: NCT02855476     History of Changes
Other Study ID Numbers: 15/0519
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The cerebrospinal fluid (CSF) and plasma samples collected in this study will be the basis of future biomarker analysis studies. A Scientific Advisory Committee which will decide how the samples will be analysed.

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias