BN42358 - PHASE IIB STUDY TO EVALUATE EFFICACY AND SAFETY OF IV PRASINEZUMAB IN PARKINSON’S DISEASE

• Research type

  Research Study

• Full title

  A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE

• IRAS ID

  1003560

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2020-004997-23

• Research summary

  The purpose of this study is to compare the effects of prasinezumab versus placebo on patients with early Parkinson’s disease who are taking standard medication to manage their disease symptoms.\n\nPrasinezumab is an antibody which binds to a protein called α-synuclein, which is normally found in the human brain. In Parkinson’s disease, α-synuclein clumps together inside brain cells, which causes the cells to become unhealthy. Disease symptoms are related to the amount of abnormal α-synuclein clumps, and where in the brain they are located. Prasinezumab may clear away harmful forms of α-synuclein to prevent damage to brain cells, potentially slowing the course of Parkinson’s disease.\n\nPrasinezumab is an experimental study drug, which means health authorities have not approved Prasinezumab for the treatment of Parkinson’s disease or any other indication.\n\nThere are 2 treatment groups (prasinezumab or placebo) where participants will be given study drug every 4 weeks in combination with their standard medication for at least 18 months, continuing on treatment until the last participant has been on treatment for 18 months. Neither the participant or site staff will know which treatment group they are in.\n\nApproximately 36 participants will take part in the study in the UK at 9 sites, with 575 participants recruited worldwide.\n\nThe study is sponsored by F. Hoffman La Roche\n\nResearch Summary; Version 1.0 18 Jan 2021;

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  21/EE/0055

• Date of REC Opinion

  20 Apr 2021

• REC opinion

  Further Information Favourable Opinion