Status:
Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Integrative Research Laboratories
Enrollment:
74
Study Design:
Randomized, double blind, placebo controlled, multi-centre (20 locations) assessing a 2.5mg capsule of IRL-790. Inclusion criteria require PwP between the ages of 18 and 79 on a stable regimen of anti-parkinsonian medication. They must display waking day dyskinesia of >25% determined as a score of >2 on question 4.1 of the UPDRS part IV. One intriguing inclusion criterion is that participants must be willing and able to avoid direct exposure to sunlight from day 1 to day 28.
Rationale:
Primary outcome: the UDysRS score at 4 weeks. Secondary outcomes are also focused on efficacy, all measured at 4 weeks: 1. UDysRS parts III and IV; 2. Participant diaries assessing change in daily off time, measured every half hour during 24 hours at visit 1; 3. UPDRS part III; 4. UPDRS part IV questions 4.1 and 4.2 related to dyskinesia.
Comments:
This study is a Phase 2a study to further assess efficacy of IRL-790 in the reduction of dyskinesia. The trial is still in the early stages but it will be interesting to see if D3 antagonism can deliver anti dyskinetic benefits without compromising motor control.
