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:  

All

Accepts Healthy Volunteers:  

No

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:

  1. Male or female ≥18 and ≤79 years of age.
  2. Signed a current Ethics Committee approved informed consent form.
  3. Parkinson’s disease, per UK Parkinson’s Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.
  4. Waking day dyskinesia of ≥25% determined as a score of ≥2 as per Question 4.1 of the MDS-UPDRS.
  5. 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.
  6. Taking a maximum of eight regular levodopa intakes per day, excluding bedtime and night time levodopa.
  7. 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).
  8. Patient must be willing and able to avoid direct exposure to sunlight from day 1 to day 28.
  9. 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:

Full information about this project

https://clinicaltrials.gov/ct2/show/NCT03368170?term=IRL790&cond=Parkinson+Disease&rank=1

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