drugset / Trial / NCT03368170

Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia

NCT03368170 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Mesdopetam (IRL790) is an experimental small molecule compound with psychomotor stabilizing properties. The primary target is the dopamine D3 receptor, a target implicated in the generation of levodopa-induced dyskinesia, a side-effect frequently occurring with long-term levodopa treatment in patients with Parkinson's disease. In experimental animals mesdopetam potently reduced levodopa-induced involuntary movement without impairing the antiparkinsonian effect of levodopa. The primary purpose of the trial is to investigate whether mesdopetam given as adjunctive treatment can reduce levodopa induced dyskinesia in patients with Parkinson's disease. The trial will also help to establish the most optimal dosing of the compound.

Timeline

Start
2018-04-12
Primary completion
2019-06-12
Completion
2019-06-12

Outcome

Missed primary endpoint

release “Analysis of UDysRS, the primary efficacy variable, showed no statistical difference between IRL790 and placebo in the per protocol analysis set (PPAS) or full analysis set (FAS).” irlab.se ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesdopetam Small molecule 2.5 mg Oral

Indications