The purpose of this Phase III study is to evaluate the efficacy and safety of RG6042 treatment for manifest Huntington’s disease. This global study will involve 80-90 sites in approximately 15 countries around the world We are pleased to tell you that set up of the GENERATION HD1 study has continued and today we are sharing that Spain and the United Kingdom will be a part of the Phase III study. It is important to note that these sites are not fully activated nor recruiting yet. We hope to complete the final steps as quickly as possible.
Additional countries/sites involved with the study will be announced on a progressive basis – as we obtain country approvals and when sites are nearly ready to enrol patients. More information about the study will be posted on ClinicalTrials.gov, including individual site status.
Spain expected sites for GENERATION HD1 study
Badajoz, Badajoz – Hospital Infanta CristinaBarakaldo, Vizcaya – Hospital Universitario De CrucesBarcelona, Barcelona – Hospital Clínic De BarcelonaBarcelona, Barcelona – Hospital De La Santa Creu I Sant PauBurgos, Burgos – Hospital Universitario De BurgosMadrid, Madrid – Hospital Ramón Y CajalMadrid, Madrid – Hospital Universitario Fundación Jiménez DíazSevilla, Sevilla – Hospital Virgen MacarenaValencia, Valencia – Hospital Universitari I Politècnic La FeThe Roche Spain Medical Information team can be contacted for more information about these sites/the study: firstname.lastname@example.org
United Kingdom expected sites for GENERATION HD1 study
Aberdeen – Aberdeen Royal InfirmaryBirmingham – Birmingham and Solihull Mental Health Foundation TrustCambridge – Cambridge Centre for Brain RepairCardiff – University Hospital of WalesGlasgow – Queen Elizabeth University Hospital GlasgowLeeds – Leeds General InfirmaryLondon – National Hospital for Neurology and NeurosurgeryManchester – Central Manchester University Hospitals NHS Foundation TrustOxford – John Radcliffe HospitalSheffield – Sheffield Children’s NHS TrustSouthampton – University Hospital Southampton NHS Foundation TrustThe Roche UK Medical Information team can be contacted for more information about these sites/the study: (+44) 0800 3281629 or email@example.com
Separately, the observational HD Natural History study (Clinicaltrials.gov ID: NCT03664804) is open and some of the sites have started recruiting. The planned 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.
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.
About the Phase III GENERATION HD1 Study The GENERATION HD1 study will evaluate the efficacy and safety of RG6042 treatment given once per month or once every two months (bi-monthly) over a period of 25 months (approx. two years). This global study will enroll up to 660 patients with manifest HD at 80-90 sites in approximately 15 countries around the world.
GENERATION HD1 is designed to determine the effectiveness and safety of RG6042, and therefore includes a comparison to placebo. Participants will be randomized to one of three treatment study arms: RG6042 monthly, RG6042 bi-monthly or placebo monthly. This means for every two participants randomized to RG6042, one will receive placebo. The study is “double-blinded,” meaning neither the participant nor his/her investigator or site staff will know which study arm the participant is assigned.
For all patients who complete the GENERATION HD1 study, an open-label extension study with the option of receiving RG6042 (no placebo control) is planned, pending eligibility, approval by Authorities and Ethics Committees/Institutional Review Boards and if data support the continued development of RG6042.
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 operationalize the study as quickly and completely as possible, patient population, and geographic location.
We have designed the program to provide the required data to Authorities so that the benefit-risk of RG6042 can be determined as quickly as possible. Our ultimate goal is that this investigational medicine can be approved by Health Authorities, and made accessible to the broader HD community.