Objective: The primary objective was to investigate the safety and tolerability of IRL790 in PD patients with LID in a randomized controlled trial.

Background: IRL790 is a novel compound with psychomotor stabilizing properties primarily targeting the dopamine D3 receptor. IRL790 is developed as an experimental treatment for levodopa-induced dyskinesia (LID), impulse control disorder and psychosis in Parkinson’s disease (PD).

Methods: PD patients with peak-dose dyskinesia were randomized to placebo or IRL790 treatment (1:3 ratio) for 4 weeks. Study drug was given as an adjunct treatment to the patients’ regular stable antiparkinsonian medication. Dosing was individually titrated for 14 days where after dosing was kept stable for an additional 14 days.

Results: Fifteen patients were randomized to treatment and thirteen patients completed the four-week treatment. Adverse events were mostly reported during the titration phase of the trial. They, were mainly central nervous system related and could be mitigated by dose adjustments. There were no serious adverse events. There were no clinically significant changes in vital signs, electrocardiogram and laboratory parameters due to the treatment. The average dose in the stable dose phase was 18 mg daily, yielding a 2-hour post-dose plasma concentration of average 229 nM on Day 28. Assessments for motor function showed a numeric reduction in dyskinesia with no impairment of Parkinsonism by IRL790 treatment.

Conclusions: IRL790 can be safely administered to patients with advanced PD. The results will be of guidance for the design of phase 2 studies.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-phase-ib-trial-studying-the-safety-and-tolerability-of-irl790-in-patients-with-parkinsons-disease-and-levodopa-induced-dyskinesia/