On Thursday 19 October, Amylyx Pharmaceuticals presented a poster for a phase 3 global study at the Neuro 2023: PSP & CBD International Research Symposium, an event organised by PSPA and CurePSP.
The poster details the study design for a double blind, placebo-controlled phase 3 study to test the effectiveness of a medication called AMX0035 in approximately 600 participants. The trial design was developed with patient involvement, including members of PRIM (PSPA’s Research Involvement Members).
Phase 3 trials are the last phase of testing before the new treatment can be submitted for marketing approval.
The Amylyx trial aims to test if AMX0035 can effectively slow progression of neurodegenerative diseases such as PSP. And also to see if it helps to improve movement in people living with PSP.
Amylyx Pharmaceuticals is looking to recruit participants across North America and Europe (including the UK) and Japan, and aim to begin recruitment in America in December. Recruitment will begin in the UK during 2024.
Participants will need to meet the following criteria:
- Diagnosed with probable or possible PSP
- Living with PSP for less than five years
- Aged between 40 and 80 years
- Have no feeding tube
- Able to travel to take part in the study.
Anyone interested in the study can register for PSPA’S Research register.
Read Amylyx’s press release about the study here.