StarMS (Autologous Stem Cell Transplantation versus Alemtuzumab or Ocrelizumab in Relapsing Remitting Multiple Sclerosis) - trial launch postponed
Due to the recent ABN and EBMT guidelines regarding Covid-19, the StarMS trial launch date will be delayed until the pandemic is over. At present the exact launch date is unknown but we will provide regular newsletter updates as more information becomes available. The study has already received REC approval and MHRA approval.
A brief summary of the trial is provided below, and more details are available on the StarMS website (www.sheffield.ac.uk/scharr/starms).
This NIHR EME funded parallel-group rater-blinded RCT will randomise 198 patients (1:1) to aHSCT versus DMT (Alemtuzumab or Ocrelizumab) from 19 centres across the UK. The primary endpoint, NEDA rate, will be assessed throughout the 2-year follow-up period.
The trial is sponsored by Sheffield Teaching Hospitals, and the Chief Investigator is Professor John Snowden (University of Sheffield). The Lead Neurologists are Professor Basil Sharrack (University of Sheffield) and Professor Paolo Muraro (Imperial College London).
The key inclusion criteria are:
- Age 16-55
- Have a diagnosis of MS using the 2017 McDonald criteria
- EDSS score 0-6.0 inclusive
- RRMS with 2 or more protocol defined relapses, or 1 such a relapse and evidence of MRI disease activity >3 months before or after its onset, in last 12 months despite being on a DMT.
The key exclusion criteria are:
- Diagnosis of primary or secondary progressive MS.
- Disease duration of >10 years from symptom onset
- Previous use of Alemtuzumab, Ocrelizumab or Cladribine
- Previous HSCT for any reason, or any previous experimental or commercial stem cell therapy.
Further information is available via the trial website (www.sheffield.ac.uk/scharr/starms) or by emailing firstname.lastname@example.org
- Recruitment re-opens post-COVID 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. Having been on pause during the pandemic, recruitment has now re-opened and we are actively looking for the final 200 patients to take us to our target of 1000!
Routes of referral include:
- Directing patients to the trial registration website, www.ms-stat2.info
- 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 1000 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 that high dose simvastatin reduced the annualised rate of brain atrophy by 43% compared to placebo over 2 years .
Key inclusion criteria include: a diagnosis of SPMS in patients aged 25-65 (inclusive); 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 (though future siponimod treatment, if licenced, is allowable in trial), 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.
Ref: 1. Chataway, J et al. The Lancet 383.9936 (2014): 2213-2221.
MIROCALS (Modifying Immune Response & OutComes in ALS)
MIROCALS (www.mirocals.eu) has now completed recruitment and the final efficacy analysis is scheduled for late 2021. Please direct any queries about the study to: Professor P Nigel Leigh, Chief Investigator, e-mail: email@example.com, or: firstname.lastname@example.org
Conversion disorder survey
We would be grateful if you could take 10 minutes to complete this short online survey on conversion disorder (functional neurological symptoms disorder) if you have not already done so. The ABN supported this research previously in 2009, with an excellent response rate from members. The results were published in the Journal of Neurology, Neurosurgery and Psychiatry (Kanaan RA, Armstrong D, Wessely SC. Neurologists' understanding and management of conversion disorder. JNNP 2011 Sep;82(9):961-6). We are keen to look at how things may have changed over the last decade. All responses will be anonymous. To complete the survey, please click here.
- Placebo survey (10 minutes)
Our clinical research training fellow Dr Anne-Catherine Huys is running a survey on doctors’ and patients’ opinion on whether or not placebo treatments should be used in clinical practice; and on what the current clinical practice is. The survey only takes 10 minutes, is anonymous and can be done by clicking this link.
- Delivery of the diagnosis of a progressive neurological condition - PhD Project
- Neurologists who deliver the diagnosis for conditions such as MND, MS, HD, PD are kindly asked to complete this short survey about their practice and perspectives on diagnosis communication for a PhD project at Lancaster University - Link
- In addition, neurologists who would like to participate in a qualitative study on the same project and talk about their experiences of breaking bad news can find more information here and send an email to email@example.com.
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 (firstname.lastname@example.org)