HDClarity at a glance
  • Sponsored by: CHDI Foundation, Inc. & University College, London
  • Official Title:  HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington’s Disease
  • Involves:  Collection of medical history, blood and Cerebrospinal fluids and Cognitive, movement and other neurological tests.
  • Study type: Clinical Observational trial
  • NB!:  Participants must also be enrolled in Enroll-HD
  • Purpose: HDClarity seeks to enroll participants at all stages of Huntington’s disease (HD) and healthy controls into a cerebrospinal fluid collection study.The main objectives are to generate high quality cerebrospinal fluid (CSF) and plasma sample collections that will allow for evaluation of biomarkers and pathways of relevance to HD research, and enable research and development of novel treatments for HD. Further information can be found at HDclarity.net.
  • Status: See trial sites below for details on recruitment status

 

Eligibility Criteria

Ages Eligible for Study: 21 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes

 

Inclusion Criteria

  1. All eligible participants:a. Are 21-75 years of age, inclusive; and b. Are capable of providing informed consent or have a legal representative authorized to give consent on behalf of the participant; and c. Are capable of complying with study procedures, including fasting, blood sampling and lumbar puncture; and d. Are participating in the Enroll-HD study; and e. Will have had an Enroll-HD visit within two months of the Screening Visit.
  2. For the Healthy Control group, participants eligible are persons who meet the following criteria:a. Have no known family history of HD; or b. Have known family history of HD but have been tested for the huntingtin gene CAG expansion and are not at genetic risk for HD (CAG < 36).
  3. For the Early Pre-manifest HD group, participants eligible are persons who meet the following criteria:a. Do not have clinical diagnostic motor features of HD, defined as Unified Huntington’s Disease Rating Scale (UHDRS) Diagnostic Confidence Score < 4; and b. Have CAG expansion ≥ 40; and c. Have burden of pathology score, computed as (CAG – 35.5) × age, < 250.
  4. 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.
  5. 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 ≥ 40; and
    3. Have Stage I or Stage II HD, defined as UHDRS Total Functional Capacity (TFC) scores between 7 and 13 inclusive.
  6. 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 ≥ 40; and
    3. Have Stage III HD, defined as UHDRS TFC scores between 3 and 6, inclusive.
  7. 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 ≥ 40; and
    3. Have Stage IV HD, defined as UHDRS TFC scores between 0 and 2, inclusive.

Exclusion Criteria

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

  1. 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 medications or nutraceuticals, the use of inappropriate (e.g., non prescribed) 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 likely to reduce the utility of the samples and data for the study of HD; 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 more than 10% 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 any combination of blood test results that the Site Principal Investigator deems to be of clinical significance; 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:

i. any reason to suspect abnormal bleeding tendency, e.g. easy bruising, petechial rash; or ii. any reason to suspect new focal neurological lesion, e.g. new headache, optic disc swelling, asymmetric focal long tract signs; or iii. any other reason that, in the clinical judgment of the Site Principal Investigator, it is felt that lumbar puncture performed per this protocol and associated manuals is unsafe without brain imaging.

m. Serious Adverse Event (SAE) related to study procedures during or following any previous HDClarity Sampling Visit (if applicable), or SAE related to any other lumbar puncture in the previous 12 months.

 

TRIAL SITES

 

GERMANY

 

Trial site: University Hospital Ulm

 

  Status: Recruiting 

 

Address: Ulm, Baden-Württemberg, Germany, 89081
Contact:  Sonja Trautman

 

 

 

Telephone: +49 731 50063023

 

 

 

Email:   sonja.trautmann@uni-ulm.de

 

 

 

 

 

Trial site: St Josef And Elisabeth Hospital

 

  Status: Recruiting 

 

Address: Bochum, Germany, 44791
Contact: Barbara Kaminski

 

 

 

 

Telephone: Not available at the moment

 

 

 

Email: b.kaminski@klinikum-bochum.de

 

 

 

 

 

 

Trial site: University Hospital of Erlangen

 

  Status: Recruiting 

 

Address: Erlangen, Germany, 91054
Contact: Susanne Seifert

 

 

 

Telephone: +49 9131 85 44751

 

 

 

Email: seifert@uk-erlangen.de

 

 

 

 

 

 

 

Trial site: George Huntington Institute

 

  Status: Recruiting 

 

Address: Münster, Germany, 48149
Contact: Anja Kletsch

 

 

 

Telephone: +49 251 788 788 0

 

 

 

Email: anja.kletsch@ghi-muenster.de

 

 

 

 

ITALY

Trial site: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta   Status: Recruiting 

 

Address: Milan, Italy, 20133
Contact: Lorenzo Nanetti

 

 

 

 

Telephone: (+)39 0223942519

 

 

 

 

Email: lorenzo.nanetti@istituto-besta.it

 

 

 

 

 

 

Trial site: Lega Italiana Ricera Huntington

 

  Status: Recruiting 

 

Address: Rome, Italy, 00185
Contact: Barbara D’Alessio

 

 

 

 

Telephone: (+)39 0644700887

 

 

 

Email:  barbara.dalessio@lirh.it

 

 

 

 

 

UNITED KINGDOM

 

Trial site: Royal Devon & Exeter NHS Foundation Trust

 

  Status: Recruiting 

 

Address: Exeter, Devon, United Kingdom, EX2 5DW
Contact: Sarah Irvine

 

 

 

Telephone:  01392406979

 

 

 

Email: sarah.irvine@nhs.net

 

 

 

 

 

 

Trial site: Glasgow Clinical Research Facility

 

  Status: Recruiting 

 

Address: Glasgow, Scotland, United Kingdom, G51 4TF
Contact: Murray Sutherland

 

 

 

 

 

Telephone: 0141 232 7600

 

 

 

 

 

Email: murray.sutherland@ggc.scot.nhs.uk

 

 

 

 

 

 

 

Trial site: Birmingham Huntingtons Disease Clinic

 

  Status: Recruiting 

 

Address: Birmingham, West Midlands, United Kingdom, B15 2 FG
Contact: Jennifer De Souza

 

 

 

Telephone: 0121 301 2363

 

 

 

Email:  jennifer.desouza@bsmhft.nhs.uk

 

 

 

 

 

 

 

Trial site: Cambridge University Hospitals NHS Foundation Trust   Status: Recruiting 

 

Address: Cambridge, United Kingdom, CB2 0PY
Contact: Katie Andresen

 

 

 

 

Telephone: 01223 331141

 

 

 

 

Email: kera2@cam.ac.uk

 

 

 

 

 

 

 

 

Trial site: Fife Health Board – Whyteman’s Brae Hospital

 

  Status: Recruiting 

 

Address: Kirkcaldy, United Kingdom, KY1 2ND
Contact: Fleur Davey

 

 

 

 

Telephone: 01383 623623

 

 

 

 

Email: fleurdavey@nhs.net

 

 

 

 

 

 

 

 

Trial site: Leeds Teaching Hospital Trust

 

  Status: Recruiting 

 

Address: Leeds, United Kingdom, LS7 4SA
Contact: Callum Schofield

 

 

 

 

Telephone: 0113 39 24679

 

 

 

 

Email:  callum.schofield@nhs.net

 

 

 

 

 

 

 

 

Trial site: St George’s University Of London

 

  Status: Recruiting 

 

Address: London, United Kingdom, SW17 0RE
Contact: Sally Goff

 

 

 

 

Telephone: 0208 725 5375

 

 

 

Email: sally.goff@nihr.ac.uk

 

 

 

 

 

 

 

 

Trial site: Oxford University Hospitals NHS Foundation Trust

 

  Status: Recruiting 

 

Address: Oxford, United Kingdom, OX3 9DU
Contact: Sarsha Wilson

 

 

 

 

Telephone: 01865 234607

 

 

 

Email: sarsha.wilson@nhs.net

 

 

 

 

 

 

 

 

Trial site: University Hospitals Plymouth NHS Trust

 

  Status: Recruiting 

 

Address: Plymouth, United Kingdom, PL6 5FP
Contact: Jemma Inches

 

 

 

 

Telephone: 01752 432845

 

 

 

 

Email:  jinches@NHS.net