PSP & CBD Clinical Trials
As a charity, we work with leading researchers and pharmaceutical companies to assist with designing clinical trials and recruiting participants.
PSPA doesn’t current fund clinical trials itself, but it is something we will consider in the future.
Read information about current clinical trials taking place, below.
CURRENT TRIALS
Noradrenaline treatment of apathy and impulsivity in participants with Progressive Supranuclear Palsy syndromes – NORAPS
Locations: Cambridge and Southampton, recruiting. Oxford, Newport, Brighton, Salford, Newcastle and Glasgow (coming soon!)
Contact: Dr Robert Durcan, University of Cambridge
PSP leads to early loss of noradrenic neurons. This project will investigate the safety and tolerability of the drug Atomoxetine as well as it’s effects on apathy and impulsivity in people with PSP. Their hypothesis is that atomoxetine which is used in the UK to treat ADHD will improve both apathy and impulsivity by blocking re-uptake of Noradrenaline and enhancing levels of the neurotransmitter in the brain.
Key requirements:
- Possible or probable PSP diagnosis
- Aged 50 to 85
- A suitable informant/research partner
- Stable psycho-active medication for 1 month prior to participation
- No use of SNRI (Serotonin and norepinephrine reuptake inhibitors) medications
- No history of atrial fibrillation or ischaemic heart disease.
Recruitment end is scheduled for November 2024.
A Phase 3 study of safety and efficacy of AMX0035 in Progressive Supranuclear Palsy (PSP)
Locations: USA, Japan, Europe
Contact: Amylyx Pharmaceuticals
The Phase 3 ORION trial (NCT06122662) will evaluate if the investigational drug, sodium phenylbutyrate and taurursodiol (ursodoxicoltaurine), also known as AMX0035, is safe and effective as a treatment for adults living with progressive supranuclear palsy (PSP).
AMX0035 is not currently approved by any regulatory agency for the use in PSP.
The trial will compare the safety and effectiveness of AMX0035 to placebo. A placebo looks and tastes the same as the investigational drug and is given the same way. However, the placebo does not contain the investigational drug.
UPDATE
In April 2024, it was announced the Medicines and Healthcare products Regulatory Agency (MHRA) has not accepted the clinical trial application from Amylyx of protocol A35-009, a Phase 3 study of safety and efficacy of AMX0035 in Progressive Supranuclear Palsy (PSP). As such, the initiation of the study in the UK is unable to proceed at this time.
Learn more, here.
TAKING PART IN CLINICAL TRIALS
If you are interested in taking part in future clinical trials, you can express your interest in research with PSPA by completing this form.
RESOURCE
Learn more about how and why clinical trials are conducted and the process involved by downloading our factsheet.
CONTACT US
For more information about our research activity, contact us on:
Tel: 01327 322418
