IRL790C003 Phase IIA Parkinson's Dyskinesia Study
Research type
Research Study
Full title
A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE IIA STUDY EVALUATING THE EFFICACY AND TOLERABILITY OF IRL790 IN PARKINSON’S DISEASE DYSKINESIA
IRAS ID
235469
Contact name
Camille Carroll
Contact email
Sponsor organisation
Integrative Research Laboratories AB
Eudract number
2017-003458-18
Duration of Study in the UK
0 years, 9 months, 28 days
Research summary
Parkinson's disease (PD) is a condition in which parts of the brain become progressively damaged over many years. The main symptoms of PD are involuntary shaking of the body, slow movement and stiff, inflexible muscles.
PD patients are routinely prescribed levodopa. Long-term use of levodopa is linked to uncontrollable, jerky muscle movements (dyskinesia) and affects when the person rapidly switches between being able to move and being immobile.
This study compares IRL790 to Placebo, evaluating the efficacy of IRL790 as a treatment to reduce Levodopa-Induced-Dyskinesia in PD.
Participants attend six clinic visits approximately seven days apart. Pre-treatment assessments will include PD rating scales (including a filmed part) and a Mini-Mental-State-Examination assessing cognition, requiring a minimum score of 24. Participants will complete two diaries indicating time spent in the disease states: ON (practically normal mobility)/OFF (marked decrease in mobility)/ON with troublesome dyskinesia (troubled by involuntary movements)/ASLEEP over separate 24hour periods.
Participants are randomised to active or placebo, and provide blood samples before and after their first dose of study medication. The starting dose is three capsules (IRL790 or placebo) twice daily.
For two weeks, participants take study medication and visit the clinic twice; their dosage may be altered at those visits. Participants continue at a fixed dose for two weeks. In the week prior to end of treatment, participants complete another 24hour "on/off" diary. At the end of treatment participants’ PD is reassessed (including a filmed part) and blood samples taken before and after the final dose. A follow up visit will take place a week later.
The effect of IRL790 on dyskinesia will be evaluated by comparing the PD assessments before and after treatment –filmed sections will be assessed by an independent expert. Blood samples before and after the first and final doses will be analysed for IRL790 metabolites.REC name
Wales REC 2
REC reference
17/WA/0420
Date of REC Opinion
19 Dec 2017
REC opinion
Favourable Opinion