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PSP Clinical Trial to Start Recruiting UK Participants

An international clinical trial of a potential new treatment for Progressive Supranuclear Palsy (PSP) is now recruiting participants in the relatively early stages of the disease.

The phase II trial involves a new intravenous drug which is being developed by Biogen, a biotechnology company specializing in developing medicines for neurological conditions and rare genetic disorders. The drug is an antibody that is designed to target and remove tau, the protein that forms the tangles and clumps seen in diseased nerve cells in PSP.

The clinical trial will involve around 400 people with PSP at centres across the world and aims to establish the safety and efficacy of the drug. It is a placebo-controlled trial, meaning that half the participants will be given the drug while the other half will receive placebo, which looks the same but contains no active drug. Neither the participants nor the nurses and doctors at the trial centres will know who is taking the real drug; this is an essential part of ensuring the results of the trial are robust and that any beneficial effects can be reliably attributed to the new treatment.

Where will the trial take place?

At the moment, 7 UK centres for the trial have been confirmed: London (UCL), Cambridge, Newport, Newcastle, Brighton, Liverpool and Southampton. It is possible that more centres could be added at a later date.

Who can take part?

Each centre will be recruiting only a small number of participants, with a target of around 30 participants for the whole of the UK. Please note that several of the existing centres have already reached their quota of patients to enrol or screen, although some may operate a waiting list.

In order to be considered for the trial, people with PSP will need to have experienced their first symptoms less than 5 years before enrolling and should still be able to walk independently or with minimal assistance.

The individual patient participation in the trail lasts just over a year. It is divided into a 6-week screening period (when all the necessary assessments will be carried out to check that you are eligible to participate), and a 52-week dosing period, (when either the study drug or placebo is given), with clinic visits approximately every 4 weeks. Once this portion of the trial concludes, there will also be an opportunity to participate in an open-label dosing period where everyone receives the study drug.

Participants will need to commit to monthly attendance at one of the trial centres, accompanied by a carer. Taking part in the trial will involve receiving intravenous infusions of the drug or placebo, along with a range of tests including MRI brain scans. If you have a pacemaker or other implant that prevents you from having MRI scans you will not be able to take part.

There are a number of other criteria that participants need to meet. A researcher at one of the trial centres will need to go through these with you before they can enrol you for the trial.

Where can I get more information?

You can contact the PSPA Helpline: 0300 0110 122 or helpline@pspassociation.org.uk

Our clinical trials information sheet explains how trials work and describes some of the issues you might like to consider before deciding whether or not you would like to take part.

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Comments

  1. Information sheet would be appreciated. My husband is happy to help with any research trials. His consultant neurologist is Dr Luke Massey who works in Poole and Southampton if that information helps.

  2. I’m asking for my husband when do you think the psp trials will start he’s on a list but have heard nothing to when these might be taking place ..thank you

  3. My mum is 47 years old and has young children, she has recently been diagnosed with PSP and would live the opportunity to take part in this trial and hopeful help to find help for herself or others in the future. We are manchester based but we could travel.

  4. Not sure if I’ve missed out – but I would be interested in participating in this trial.
    Recently diagnosed with notable symptoms from September 2017
    Many thanks

    1. Hi Glenda, thanks for your comment. A number of the trial centres do have a significant waiting list now and are well on their way to recruiting the small number of patients they are able to enrol. I’ll send you an email with a more comprehensive response. Best wishes, Kate

  5. Hello

    I am hoping to refer my sister aged 47 yrs and diagnosed with PSP last May. The whole family in addition to my sister will be dedicated to the trial should she ve eligible.

    Kind regards
    Sue Lomas