Director: Professor Nick Freemantle
Research areas: Brain Science, Child Health, Ophthalmology, Musculoskeletal, Women's Health, Cardiovascular, Critical Care, Surgical Trials, Early Phase Trials
Number of staff: 50
Number of trials: 17
Established in 2011 and launched in 2012 the Comprehensive Clinical Trials Unit designs, conducts, analyses and aims to publish high quality clinical trials and other well-designed studies. The unit supports researchers across UCL, as well as partner institutions, in providing clinical trials leadership and expertise across the whole range of activities required to deliver trials from concept to dissemination and implementation of research findings. Their highly experienced staff also have diverse research interests and expertise in clinical trial methodology, which serves to enhance the effectiveness of the research pathways.
The Comprehensive CTU strives to develop partnerships with clinical investigators at many relevant institutions and operates a successful ‘hub and spoke’ model: a core of multidisciplinary central activity with specialist trial teams in key clinical research facilities including Moorfields Eye Hospital, UCL Institute of Neurology and The Institute for Women’s Health.
- Case study - MS-STAT2
Type of trial: Phase III, prospective, multi-centre, double-blinded, randomised controlled trial
Chief Investigator: Professor Jeremy Chataway, Institute of Neurology at UCL and Clinical Director, CCTU
Planned number of patients to recruited: 1,180
Sites: 30 NHS neuroscience centres and other hospitals across England, Scotland, Wales and Northern Ireland, as well partners in the Republic of Ireland will be recruiting eligible SPMS patients throughout 2018-2019.
Start/end date: Trial funding commenced in March 2017, with the first patients screened in March 2018. Patient follow-up will continue until 2022.
Results: Following analysis of the data collected, trial results are expected in the summer of 2023.
Funded by: NIHR Health Technology Assessment, and the UK and United States MS Societies.
The MS-STAT2 clinical trial has been designed to test the effectiveness of repurposed simvastatin (80mg) in patients with secondary progressive MS (SPMS), to determine if the rate of disability progression can be slowed over a 3 year period.
SPMS results from a progressive neuronal degeneration that causes accumulated and irreversible disability affecting walking, balance, manual function, vision, cognition, pain control, bladder and bowel function. The pathological process driving the development of this disability is not known at present.
While treatments in the early stage of MS (relapsing-remitting MS, or RRMS) have become increasingly effective, there remains no current disease-modifying treatment (DMT) for SPMS. An earlier study, MS-STAT1, used magnetic resonance imaging (MRI) techniques to determine that patients taking simvastatin over a two year period resulted in a reduced rate of brain atrophy (a loss of neurons, or ‘brain shrinkage’) compared to those taking a placebo. That study took place with 140 patients, whereas the MS-STAT2 trial will increase patient participation considerably in an effort to determine whether simvastatin can become a DMT for SPMS.