Today, Roche announced their enrollment of European participants from Spain and UK in GENERATION HD1. Over the next two years, safety and efficacy of the drug RG6042 will be studied.
You can find the Spain and United Kingdom sites below.
One month ago, Roche announced that the first patient entered the GENERATION HD1 study. The trial will investigate the efficacy and safety of the huntingtin lowering drug RG6042, formerly known as IONIS-HTTRx.
Today it was announced that sites in Europe will start to enroll participants in the nearest future.
At the moment, this applies to clinics in Spain and the UK. Other European countries will follow soon. You can stay informed by visiting ClinicalTrials.gov.
What’s new?
Over the last couple of years, the safety and short-term effects of RG6042 have been studied in 46 participants. Now longer-term safety and efficacy will be studied in more than 600 participants.
One month ago, participants started enrolling in USA and Canada. Now European participants will enter the trial.
What’s GENERATION HD1?
GENERATION HD1 is a Phase III study, meaning that it is designed to determine whether RG6042 is safe and effective. Hopefully, the drug will “slow down” the progression of the disease and have a positive effect on symptoms.
Over a period of 25 months, some of the participants will receive RG6042 while others will receive a placebo drug. This is done in order to determine how RG6042 works.
Read more: Roche’s statement about GENERATION HD1
What’s RG6042?
RG6042 was the first drug to lower the expression of Huntingtin protein in humans. Why is this important?
‘Sick’ or mutant Huntingtin protein is not fully understood, but it is toxic to certain cell types – especially in the brain.
Reducing the amount of the ‘sick’ Huntingtin protein is therefore hypothesized as an important aspect in slowing down Huntington’s disease.
In previous trials, RG6042 is found to reduce the amount of ‘sick’ Huntingtin protein and this is further found to somewhat improve symptoms of Huntington’s disease.
Read more: Drug seems to improve Symptoms
However, the long-term effect and safety of this Huntingtin lowering is not yet known. In addition, the drug is only tested in a small group of people – which makes it difficult to say anything about the efficacy in general.
More participants is needed, as well as measurements over a longer period of time. And that is why GENERATION HD1 started one month ago.
Spain: expected sites for GENERATION HD1 study
Badajoz, Badajoz – Hospital Infanta Cristina
Barakaldo, Vizcaya – Hospital Universitario De Cruces
Barcelona, Barcelona – Hospital Clínic De Barcelona
Barcelona, Barcelona – Hospital De La Santa Creu I Sant Pau
Burgos, Burgos – Hospital Universitario De Burgos
Madrid, Madrid – Hospital Ramón Y Cajal
Madrid, Madrid – Hospital Universitario Fundación Jiménez Díaz
Sevilla, Sevilla – Hospital Virgen Macarena
Valencia, Valencia – Hospital Universitari I Politècnic La Fe
The Roche Spain Medical Information team can be contacted for more information about these sites/the study: spain.medinfo@roche.com
United Kingdom: expected sites for GENERATION HD1 study
Aberdeen – Aberdeen Royal Infirmary
Birmingham – Birmingham and Solihull Mental Health Foundation Trust
Cambridge – Cambridge Centre for Brain Repair
Cardiff – University Hospital of Wales
Glasgow – Queen Elizabeth University Hospital Glasgow
Leeds – Leeds General Infirmary
London – National Hospital for Neurology and Neurosurgery
Manchester – Central Manchester University Hospitals NHS Foundation Trust
Oxford – John Radcliffe Hospital
Sheffield – Sheffield Children’s NHS Trust
Southampton – University Hospital Southampton NHS Foundation Trust
The Roche UK Medical Information team can be contacted for more information about these sites/the study: (+44) 0800 3281629 or medinfo.uk@roche.com
Another trial, HD Natural History study, have also started recruiting participants. Sites in Canada, USA, Germany and UK were announced in November 2018. Information about the study, including individual site status, is posted on ClinicalTrials.gov (ID: NCT03664804)
The decision to join a clinical trial is personal and involves many factors. People interested in participating in any clinical research should discuss with their HD specialist about what may be best for their situation.
How are the clinical study sites selected? A variety of factors influence site selection, including assessments on experience with HD studies, clinic infrastructure capacity to run the study as well as usual site activities, ability to operationalise the study as quickly and completely as possible, patient population, and geographic location.