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Trials & Surveys

Trials 

  • Recruitment open for the MS-STAT2 trial in Secondary Progressive Multiple Sclerosis:

Jeremy Chataway (Chief Investigator) and the MS-STAT2 team would be extremely grateful if members of the ABN could put forward suitable patients for the ongoing MS-STAT2 study. Routes of referral include:

1. Directing patients to the trial registration website, www.ms-stat2.info

2. Or emailing the study team at UCLH.QSMSC@nhs.net.

This NIHR, UK and US MS society funded, academically-led phase 3 trial, will recruit 1180 patients with secondary progressive multiple sclerosis (SPMS) at over 30 sites across the UK and Ireland. This builds upon results from the original MS-STAT phase 2 study, which demonstrated high dose simvastatin reduced the annualised rate of brain atrophy by 43% compared to placebo over 2 years1.

Key inclusion criteria include: a diagnosis of SPMS in patients aged 25-65; evidence of disability progression over the previous 2 years; an EDSS score 4.0-6.5 (significant disability but able to walk approximately 500m, to those who require walking aids to walk at least 20m). Key exclusion criteria include current use of disease modifying therapies, primary progressive MS or current use of any statin. The primary outcome measure will be time to initial disability progression. The intervention will be 80mg simvastatin or placebo, randomised 1:1 over a 3 year trial. Active study sites are outlined on the map

Ref: 1. Chataway, J et al. The Lancet 383.9936 (2014): 2213-2221.

 

MIROCALS (Modifying Immune Response & OutComes in ALS)

MIROCALS (Modifying Immune Response & OutComes in ALS: www.mirocals.eu; https://www.mndassociation.org/) trial is still open to recruitment. MIROCALS is a RCT of low dose interleukin-2 (ld IL-2) as a Treg enhancer for controlling neuro-inflammation, administered as an addon therapy to riluzole. Patients will be started on riluzole and after 3 months randomised to ld IL-2 or placebo for 18 months. Survival is the primary outcome measure. It is funded through the European Union H2020 programme in partnership with the MND Association, and the sponsor is the University Hospital of Nimes, France. The Coordinator is Dr Gilbert Bensimon (Paris and Nimes) and Chief Investigator is Professor Nigel Leigh (Brighton and Sussex Medical School). Recruitment as of June 2019 stands at 274 subjects with 175 randomised. Thus far, there have been no safety concerns. We aim to complete recruitment by the end of September 2019 and randomisation by the end of January 2020, with follow-up for survival until July 2021. We are confident that we are on track to achieve our goal for randomisation.

Key features for inclusion are: ALS(MND) El Escorial Possible, Probable and Definite; no treatment with riluzole; disease onset (motor symptoms) within 24 months of inclusion; VC 70% or more; willing to have lumbar punctures for CSF biomarker studies; absence of  exclusion criteria (especially no immunological disease or cancer- full list on request). LP has proved acceptable so far! We aim to recruit up to 120 participants in the UK (216 in total in UK and France) and so would encourage you to consider referring any potential participants to one of the 7 recruiting sites in the UK. If in doubt about a patient’s eligibility please contact one of the Principal Investigators, and/or Prof Nigel Leigh (P.Leigh@bsms.ac.uk; 07956 480 417) and we will send more detailed information. 

Participating Centres and key contacts include: Royal Sussex County Hospital, Brighton – PI: Prof P Nigel Leigh (P.Leigh@bsms.ac.uk); King's College Hospital, London – PI: Prof Ammar Al-Chalabi (ammar.al-chalabi@kcl.ac.uk); National Hospital for Neurology and Neurosurgery, London – PI: Dr Nikhil Sharma (nikhil.sharma@ucl.ac.uk); The Royal London Hospital, London – PI: Dr Andrea Malaspina (a.malaspina@qmul.ac.uk); Royal Hallamshire Hospital, Sheffield – PI: Prof Dame Pamela Shaw, with Prof Chris McDermot (pamela.shaw@sheffield.ac.ukc.j.mcdermott@sheffield.ac.uk); Salford Royal Foundation Trust – PI: Dr John Ealing (John.Ealing@srft.nhs.uk); Queen Elisabeth University Hospital, Glasgow – PI: Dr George Gorrie (george.gorrie@nhs.net)

 

  • ECST-2

The Second European Carotid Surgery Trial (ECST-2) is a multicentre randomised controlled trial (RCT), funded by the NIHR Research for Patient Benefit Scheme and by the Stroke Association, UK.  The trial is designed to investigate the hypothesis that in patients with atherosclerotic carotid artery stenos is at low and intermediate risk for stroke, optimised medical treatment (OMT) will avoid the need for carotid revascularisation.  Asymptomatic or symptomatic patients with >50% carotid artery stenosis and a low to intermediate risk of recurrent stroke, will be randomly allocated to be treated by carotid revascularisation with OMT  (“immediate revascularisation”) or OMT alone (“delay revascularisation until more clearly indicated”).  Substudies of the trial include carotid plaque imaging with MRI and US, histological analysis of the plaque and genetics.  The ECST-2 Trial Group, led by Professor Martin Brown (Chief Investigator) is based at the UCL Institute of Neurology, London UK.  For further information on the trial please contact Dr Roland Featherstone, Trial Manager.  Alternatively you can visit the trial website.

 

Surveys

  • Help raising awareness of seizure audit in hospitals

Could you participate in the third round of the National Audit of Seizure Management (NASH) (http://www.nashstudy.org.uk)? NASH sets out to describe the variations of Epilepsy care given across hospitals in the UK and to highlight opportunities to improve care.  There have been 2 earlier rounds of NASH in 2011 and 2013. As well as European Audit (EuroNASH) (http://www.euronash.eu), which took place in 2017/2018. The UK audits included over 80% of EDs and data were collected on over 8000 patients. Significant deficiencies in the coordination of care were identified including:

- Almost two thirds of patients attending ED with known epilepsy had not seen a specialist within the previous 12 months or were on therapy that was sub-optimal

- Assessment of the acute seizure was less than optimal in more than half of patients

- Less than half were referred onward to neurology or epilepsy services for further investigation and management.

- Considerable variability in care was identified. Some sites performed consistently well, despite on-going challenges, whilst others did not.

We believe that now is the time to undertake another round of the Audit to identify whether care has improved following an opportunity to implement changes. Each participating Trust is asked to identify 30 consecutive patients attending the ED with a seizures, and provide anonymous data via a secure website. Feedback from previous audits is that this was simple to do and most data were collected by medical staff. Further information can also be found at http://www.nashstudy.org.uk. If you/your trust would like to participate, please contact info@nashstudy.co.uk

Audit Questions

NASH3 Protocol

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  • Delivery of the diagnosis of a progressive neurological condition - PhD Project

Researchers at Lancaster University are looking for neurologists to take part in a survey about the delivery of the diagnosis of a progressive neurological condition. This survey is exploring your current practice and your experiences of communicating the diagnosis for a neurological condition (Parkinson’s disease, Multiple Sclerosis, Motor neurone disease, Huntington’s disease). Completing the survey should take approximately 15-20 minutes.  Please click on the link below if you want to read more about our project’s nature and aims and decide if you would like to participate.https://lancasteruni.eu.qualtrics.com/jfe/form/SV_ex6hPSbPnRY8zgp

 

Researchers at the University of Southampton are looking for neurologists to take part in a MS research project.

The project is exploring your experiences of communicating prognosis to patients with Multiple Sclerosis. Participation will involve a telephone interview at a time and place that is convenient for you and the interview is predicted to last around 45 minutes to an hour. In return for your participation, you will receive a £15 Amazon voucher and a certificate stating that you have helped with this research, which might be useful in your professional appraisal or revalidation. We would also be happy to provide a transcript of the conversation if you wish, for use as an example of reflection on one’s practice. The interview will provide an opportunity for reflection that may be useful for your appraisal. Ultimately, the research aims to contribute towards understanding and improving prognosis communication and Healthcare Professional-Patient relationships. If you are interested in participating or simply want to find out more, please contact Samantha Hornsey at the University of Southampton (sh7g13@soton.ac.uk)

 

RECODE-DCM – “Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy”.
What problem are we addressing?
Degenerative Cervical Myelopathy (DCM), arises when arthritic changes of the cervical spine compress and injure the spinal cord. It is estimated to affect up to 2% of adults. Currently few patients make a full recovery, living with life-long disability and poor quality of life. Research advances are urgently needed.

It is estimated that 85% of healthcare research fails to deliver an actual or potential healthcare benefit; deficiencies in the design of research, especially failure to consult relevant stakeholders, are a leading contributor.

How can we address this in DCM?
Organizations such as the James Lind Alliance (JLA) and Core Outcome Measures in Effectiveness Trials (COMET) advocate multi-stakeholder priority-setting partnerships and core-outcome sets.

AOSpine and the University of Cambridge are leading a JLA-informed DCM study. RECODE-DCM seeks to engage stakeholders from across the globe to reach a consensus on the research priorities, a core outcome set, core data elements, a core measurement set and the definition of DCM.

We need your help!
The involvement of all stakeholders is essential: health professionals, patients, relatives and caregivers. Participation involves completing a short online survey. All participants can register to be indexed as collaborators on RECODE-DCM publications.

Survey link: https://recode-dcm.com/how-to-participate  
Further information: https://recode-dcm.com/.
Queries to Olesja Hazenbiller: ohazenbiller@aospine.org

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