HDClarity
Research type
Research Study
Full title
HDClarity: a multi-site cerebrospinal fluid collection initiative to facilitate therapeutic development for Huntington’s disease
IRAS ID
185506
Contact name
Suzanne Emerton
Contact email
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
15/0519 , UCL R&D reference number; Z6364106/2015/07/34, UCL Data Protection Number
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
UCL to act as the managing research organisation and central coordinating body for the study and study sponsor. The study (described below) will be active in approximately 12 countries including the UK, USA, Canada, Australia, Germany, Italy and Spain.
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. 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.
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.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
16/LO/1878
Date of REC Opinion
13 Dec 2016
REC opinion
Further Information Favourable Opinion