Efficacy and Tolerability of IRL790 in Parkinson’s Disease Dyskinesia – UK Trial
IRL790 is an experimental small molecule being investigated to see whether IRL790 given as alongside current treatment can reduce levodopa induced dyskinesia in patients with Parkinson’s disease.
IRL790 is being trialled across 15 UK sites and is currently looking to recruit 74 patients into the study.
Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients will be randomised into the study and either be given the active compound, or a placebo. The primary outcome of the trial will involve patients being assessed using the Unified Dyskinesia Rating Scale (UDysRS) at the start of the study to obtain a baseline, and again at several key points throughout to ascertain any changes in dyskinesia and motor function in general.
A number of other tests will also be completed to assess the treatment. Patients will be required to complete 2 x 24 hour diaries, 1 before treatment and also 1 during treatment where they monitor the motor function in 30 minute intervals.
To be considered for the study patients must meet the following inclusion criteria:
- Male or female ≥18 and ≤79 years of age.
- Signed a current Ethics Committee approved informed consent form.
- Parkinson’s disease, per UK Parkinson’s Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.
- Waking day dyskinesia of ≥25% determined as a score of ≥2 as per Question 4.1 of the MDS-UPDRS.
- On a stable regimen of antiparkinson medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily and willing to continue the same doses and regimens during study participation. Rescue medication such as Madopar dispersable and Apomorphine injections are allowed.
- Taking a maximum of eight regular levodopa intakes per day, excluding bedtime and night time levodopa.
- Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening and the patient must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis).
- Patient must be willing and able to avoid direct exposure to sunlight from day 1 to day 28.
- Able to complete at least one valid 24-hour patient diary at Visit 1.
Further details of the trial, including exclusion criteria can be found at: https://clinicaltrials.gov/ct2/show/NCT03368170?term=IRL790&cond=Parkinson+Disease&rank=1
I’d like to take part – who should I contact?
To get involved, please contact one of the following sites:
- Plymouth – Catherine Pitman (email@example.com) or (01752 431807)
- Nottingham – Lani Paterson (Lani.firstname.lastname@example.org) or (01159 249924 ext 66517)
- Bristol – Sarah Dunn – (email@example.com) or (0117 4148270)
- North Shields – Steve Dodds (Steve.firstname.lastname@example.org) or (0191 2934087)
- Peterborough – Natalie Temple (Natalie.email@example.com) or (01733 673891)
- Oxford – Charlotte Woodward (Charlotte.Woodward3@ouh.nhs.uk) or (01865 231556)
- Bury – Sanniah Hussain (Sanniah.Hussain@pat.nhs.uk) or (0161 778 2259)
- Luton – Yvynne Croucher (firstname.lastname@example.org) or (01582 718733)
- London – Emmima Monoharan (email@example.com) or (02034 484193)
- Lincoln – Susie Butler (Susie.butler@ULH.nhs.uk) or (01522 512512)
- Staffordshire – Claire Everill (Claire.firstname.lastname@example.org) or (01782 715444)
- Essex – Laura Parker (email@example.com) or (01708 435023)
- Stoke – Martin Booth (firstname.lastname@example.org)
- Charing Cross – Idah Mojela (email@example.com) or (0203 3111718 /1714)
Full information about this project