Status and phase
Conditions
Treatments
About
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.
Full 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 KinetiGraphâ„¢, 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
History of any clinically significant disease or disorder which, in the opinion of the Investigator, could either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
History of or present clinically significant psychiatric diagnosis, at discretion of the Investigator.
History of seizures, including febrile seizure in childhood.
History or presence of hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Any clinically significant illness, medical/surgical procedure or trauma within four weeks of the first administration of IMP.
Any planned major surgery within the duration of the study.
Previous surgery for PD. . A Hoehn and Yahr score of 5 when "off".
Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL790. 11. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that included drug treatment with less than three months between administration of last dose and first dose of IMP in this study. 12. History of alcohol abuse and/or use of drugs of abuse. 13. Investigator considered the patient unlikely to comply with study procedures, restrictions and requirements.
Primary purpose
Allocation
Interventional model
Masking
15 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal