A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia

Parkinson Disease Clinical Trial

Official title: A Randomised, Double-blind, Placebo-controlled, Phase Ib Study Evaluating the Safety and Tolerability of IRL790 in Patients With Parkinson's Disease (PD) Experiencing Levodopa (L-Dopa) Induced Dyskinesia (LID).

Status Completed

Clinical Trial Summary

This is a Phase 1b study investigating the safety and tolerability of IRl790 as adjunct therapy in patients with Parkinson disease. IRL790/placebo is taken for 28 days.

Clinical Trial Description

Consenting patients were screened for eligibility as per study-specific inclusion/exclusion criteria within 8-28 days before start of Investigational Medicinal Product (IMP) administration (Visit 1; Screening Visit). At Visit 2 (Day -7) a kinetigraph device (the Parkinson's KinetiGraph™, Global Kinetics Corporation, Melbourne, Victoria, Australia) was attached to the right or left wrist (the parkinsonian dominant side) and baseline patient movement data were recorded during a run-in period of seven consecutive days.

Following baseline assessments at Visit 3 (Day 1) patients were randomized to receive IRL790 or placebo (3:1). The treatment allocation was double-blinded, i.e. it was not disclosed to the patients, the site staff or the Sponsor. During the treatment period, Visits 4-8 were performed on Days 4, 7, 10, 14 and 28 (end of treatment) and a follow-up phone call was performed on Day 21. Dose adjustments of IRL790 could be made until Day 14, following pre-defined criteria. A follow-up visit (Visit 9) was performed 7-10 days after the last IMP dose. ;

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

• NCT number: NCT03531060
• Study type: Interventional
• Source: Integrative Research Laboratories AB
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 8, 2016
• Completion date: April 12, 2017