HDClarity
Recruiting
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.
Ages Eligible
for Study:
21 Years to 75 Years
(Adult, Older Adult)
Sexes Eligible
for Study:
All
Accepts Healthy Volunteers:
Yes
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.
For all groups, participants are ineligible if they meet any of the following exclusion criteria:
- Use of investigational drugs or participation in a clinical drug trial within 30 days prior to Sampling Visit; or
- Current intoxication, drug or alcohol abuse or dependence; or
- 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
- 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
- Needle phobia, frequent headache, significant lower spinal deformity or major surgery; or
- 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
- Clotting or bruising disorder; or
- 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
- Screening blood test results for C-reactive protein (CRP)>2× upper limit of normal; or
- Predictable non-compliance as assessed by Site Principal Investigator; or
- Inability or unwillingness to undertake any of the study procedures; or
- 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.
LOCATIONS
COUNTRIES
FRANCE
TRIAL SITE:
Centre Hospitalier Universitaire d’Angers
Address:Angers, France, 49100
CONTACT
Audrey Olivier
Tel: +33 241355615
Email:auolivier@chu-angers.fr
Recruiting
GERMANY
TRIAL SITE:
George Huntington Institute
Address: Münster, Germany, 48149.
CONTACT
Svenja Aufenberg
Tel: +49-251-788-788-0
Email:svenja.aufenberg@ghi-muenster.de
Recruiting
TRIAL SITE:
University Hospital Ulm
Address: Ulm, Baden-Württemberg, Germany, 89081
CONTACT
Olga Kuvarzina
tel: +49 731-500-63080
email: Olga.Kuvarzina@uniklinik-ulm.de
Recruiting
TRIAL SITE:
St Josef And Elisabeth Hospital
Address: Bochum, Germany, 44791.
CONTACT
Barbara Kaminski
Tel:+49 2345096405
Email:b.kaminski@klinikum-bochum.de
Recruiting
TRIAL SITE:
University Hospital of Erlangen
Address: Erlangen, Germany, 91054
CONTACT
Susanne Seifert
tel:+49 9131 85 44751
email: susanne.seifert@uk-erlangen.de
Recruiting
TRIAL SITE:
Dresden University
Address:Dresden, Saxony, Germany, 01307
CONTACT
Marian Kollaske
tel: +49 351 458 11544
email:Marian.Kollaske@ukdd.de
Recruiting
TRIAL SITE:
Kbo-Isar-Amper-Klinikum Taufkirchen (Vils)
Address: Taufkirchen (Vils), Germany, 84416
CONTACT
Michael Bachmaier
Tel: 08084-934-417
Email:michael.bachmaier@kbo.de
Recruiting
ITALY
TRIAL SITE:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Address: Milan, Italy, 20133
CONTACT
Anna Castaldo
Tel: +39 0223942519
Email:anna.castaldo@istituto-besta.it
Active, Not Recruiting
TRIAL SITE:
Lega Italiana Ricera Huntington
Address: Rome, Italy, 00185
CONTACT
Consuelo Ceccarelli
tel: +39 0644700887
email: consuelo.ceccarelli@lirh.it
Recruiting
POLAND
TRIAL SITE:
Instytut Psychiatrii i Neurologii w Warszawie (IPIN)
Address: Jana III Sobieskiego 9, 02-957 Warszawa, Polonia
CONTACT
Malgorzata Rowinska
tel: +48 698250623
Email:m.dusza.rowinska@gmail.com
Active, Not Recruiting
SPAIN
TRIAL SITE:
Hospital de Sant Pau
Address: Barcelona, Spain, 08041
CONTACT
Arnau Puig Davi
tel: +34 649 14 23 60
email: apuigd@santpau.cat
Recruiting
TRIAL SITE:
Associacion de Investigacion Sanitaria Bio-Cruces
Address: Plaza Cruces S/N | 48903 Barakaldo
CONTACT
Marian Ángeles Acera Gil
tel: +34 94600636
email: aceramarian@gmail.com
Recruiting
UNITED KINGDOM
TRIAL SITE:
Royal Devon & Exeter NHS Foundation Trust
Address: Exeter, Devon, United Kingdom, EX2 5DW
CONTACT
Julie Moss
Tel:+44( 0)1392 406979
Email:julie.moss10@nhs.net
Recruiting
TRIAL SITE:
Glasgow Clinical Research Facility
Address: Glasgow, Scotland, United Kingdom, G51 4TF
CONTACT
Helen Bannister
Tel:+44( 0)141 232 7600
Email:helen.bannister@ggc.scot.nhs.uk
Recruiting
TRIAL SITE:
Birmingham Huntingtons Disease Clinic
Address: Birmingham, West Midlands, United Kingdom, B15 2 FG
CONTACT
Elsa Benn
Tel: 0121 301 2363 Email:e.benn@nhs.net
Recruiting
TRIAL SITE:
Cambridge University Hospitals NHS Foundation Trust
Address: Cambridge, United Kingdom, CB2 0PY
CONTACT
Katie Andresen
Tel:+44(0)1223 331141 Email:kera2@cam.ac.uk
Recruiting
TRIAL SITE:
Fife Health Board – Whyteman’s Brae Hospital
Address: Kirkcaldy, United Kingdom, KY1 2ND
CONTACT
Fleur Davey
Tel: + 44(0)1383 623623 Email:fleurdavey@nhs.net
Active, Not Recruiting
TRIAL SITE:
Leeds Teaching Hospital Trust
Address: Leeds, United Kingdom, LS7 4SA
CONTACT
Naz Azam
Tel: +44(0)113 392 4679 Email:naz.azam@nhs.net
Recruiting
TRIAL SITE:
The Walton Centre NHS Foundation Trust
Address: Liverpool, United Kingdom, L9 7LJ
CONTACT
Andrea Clyne
Tel:+44(0)151 525 3611
Email:andrea.clyne@thewaltoncentre.nhs.uk
Recruiting
TRIAL SITE:
University College London Hospitals NHS Foundation Trust
Address: London, United Kingdom, NW1 2P
CONTACT
Opeyemi Kinyomi
email: o.kinyomi@ucl.ac.uk
Recruiting
TRIAL SITE:
Oxford University Hospitals NHS Foundation Trust
Address: Oxford, United Kingdom, OX3 9DU
CONTACT
Zara Skitt
Tel: +44(0)1865 234309 Email:zara.skitt@ouh.nhs.uk
Recruiting
TRIAL SITE:
University Hospitals Plymouth NHS Trust
Address: Plymouth, United Kingdom, PL6 5FP
CONTACT
Elizabeth Cray
Tel: +44(0)1752 439636
email: elizabethcray@nhs.net
Recruiting
TRIAL SITE:
North Bristol NHS Trust
Address: Bristol, United Kingdom, BS10 5NB
CONTACT
Anya Soonderpersha
Tel: +44(0)1174148242
email:Anya.Soonderpershad@nbt.nhs.uk
Recruiting
TRIAL SITE:
Cardiff University
Address: Cardiff, United Kingdom, CF24 4HQ
CONTACT
Alison Johnson
Tel:+44( 0)2920746394 Email:alison.johnson@wales.nhs.uk
Recruiting
TRIAL SITE:
St George’s University Of London
Address:London, United Kingdom, SW17 0RE
CONTACT
Hae-Ree Seo
Tel: +44(0)208 725 5375
email: HaeRee.Seo@stgeorges.nhs.uk