HDClarity

A Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington’s Disease.

Recruiting

ABOUT

SPONSOR

University College London

PARTICIPANTS

1200

HDClarity us aiming to collect a high quality Cerebrospinal fluid (CSF) for evaluation of biomarkers and pathways that will enable the development of novel treatments for Huntington’s disease (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.

Estimated Study Completion Date: April 1, 2021

Ages Eligible for Study:

21 Years to 75 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

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.

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).

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.

For the Late Pre-manifest HD group, participants eligible are persons who meet the following criteria:

  • Do not have clinical diagnostic motor features of HD, defined as Unified Huntington’s Disease Rating Scale (UHDRS) Diagnostic Confidence Score < 4; and
  • Have CAG expansion ≥ 40; and
  • Have burden of pathology score, computed as (CAG – 35.5) x age, ≥ 250.

For Early Manifest HD group, participants eligible are persons who meet the following criteria:

  • Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
  • Have CAG expansion ≥ 40; and
  • Have Stage I or Stage II HD, defined as UHDRS Total Functional Capacity (TFC) scores between 7 and 13 inclusive.

For Moderate Manifest HD group, participants eligible are persons who meet the following criteria: 

  • Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
  • Have CAG expansion ≥ 40; and
  • Have Stage III HD, defined as UHDRS TFC scores between 3 and 6, inclusive.

For Advanced Manifest HD group, participants eligible are persons who meet the following criteria:

  • Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
  • Have CAG expansion ≥ 40; and
  • Have Stage IV HD, defined as UHDRS TFC scores between 0 and 2, inclusive.
  1.  

Exclusion Criteria

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.

COUNTRIES

GERMANY

TRIAL SITE:
George-Huntington- Institut GmbH; Technologiepark Münster

Address: Münster, Germany, 48149.

CONTACT
Anja Kletsch
Tel.: +49 251 788 788 0
anja.kletsch@ghi-muenster.de

Recruiting

TRIAL SITE: 
Universitätsklinikum Ulm; Klinik für Neurologie

Address: Ulm, Baden-Württemberg, Germany, 89081

CONTACT
Sonja Trautman
Tel.: +49 731 50063023
sonja.trautmann@uni-ulm.de

Recruiting

TRIAL SITE:
Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration

Address: Bochum, Germany, 44791.

CONTACT
Barbara Kaminski
b.kaminski@klinikum-bochum.de

Recruiting

TRIAL SITE:
University Hospital of Erlangen

Address: Erlangen, Germany, 91054

CONTACT
Susanne Seifert
Tel.: +49 9131 85 44751
seifert@uk-erlangen.de

Recruiting

ITALY

TRIAL SITE:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Address: Milan, Italy, 20133

CONTACT
Lorenzo Nanetti
Tel.: +39 0223942519
lorenzo.nanetti@istituto-besta.it

Recruiting

TRIAL SITE: 
Lega Italiana Ricera Huntington

Address: Rome, Italy, 00185

CONTACT
Barbara D’Alessio
Tel.: +39 0644700887
barbara.dalessio@lirh.it

Recruiting

UNITED KINGDOM

TRIAL SITE:
Royal Devon & Exeter NHS Foundation Trust

Address: Exeter, Devon, United Kingdom, EX2 5DW

CONTACT
Sarah Irvine   
Tel.: 01392406979
sarah.irvine@nhs.net   

Recruiting

TRIAL SITE: 
Glasgow Clinical Research Facility

Address: Glasgow, Scotland, United Kingdom, G51 4TF

CONTACT
Murray Sutherland   
Tel.: 0141 232 7600
murray.sutherland@ggc.scot.nhs.uk   

Recruiting

TRIAL SITE:
Birmingham Huntingtons Disease Clinic

Address: Birmingham, West Midlands, United Kingdom, B15 2 FG

CONTACT
Jennifer De Souza
Tel.: 0121 301 2363    jennifer.desouza@bsmhft.nhs.uk

Recruiting

TRIAL SITE:
Cambridge University Hospitals NHS Foundation Trust

Address: Cambridge, United Kingdom, CB2 0PY

CONTACT
Katie Andresen   
Tel.: 01223 331141    kera2@cam.ac.uk   

Recruiting

TRIAL SITE: 
Fife Health Board – Whyteman’s Brae Hospital

Address: Kirkcaldy, United Kingdom, KY1 2ND

CONTACT
Fleur Davey   
Tel.: 01383 623623    fleurdavey@nhs.net   

Recruiting

TRIAL SITE:
Leeds Teaching Hospital Trust

Address: Leeds, United Kingdom, LS7 4SA

CONTACT
Callum Schofield   
Tel.: 0113 39 24679    callum.schofield@nhs.net   

Recruiting

TRIAL SITE:
The Walton Centre NHS Foundation Trust

Address:Liverpool, United Kingdom, L9 7LJ

CONTACT
Almudena Duran-Rosas
Tel.:0151 525 3611    almudena.duran-rosa@thewaltoncentre.nhs.uk

Recruiting

TRIAL SITE: 
St George’s University Of London

Address: London, United Kingdom, SW17 0RE

CONTACT
Sally Goff   
Tel.: 0208 725 5375    sally.goff@nihr.ac.uk

Recruiting

TRIAL SITE:
Oxford University Hospitals NHS Foundation Trust

Address: Oxford, United Kingdom, OX3 9DU

CONTACT
Sarsha Wilson   
Tel.: 01865 234607    sarsha.wilson@nhs.net      

Recruiting

TRIAL SITE:
University Hospitals Plymouth NHS Trust

Address: Plymouth, United Kingdom, PL6 5FP

CONTACT
Jemma Inches   
Tel.: 01752 432845    jinches@NHS.net   

Recruiting