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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Adverse Events
Medical Dictionary for Regulatory Activities Preferred Term
Time frame: 4 weeks
Physical examination
Number of participants with clinically significant abnormal physical examination findings
Time frame: 4 weeks
Electrocardiogram (ECG) recordings
Number of participants with clinically significant abnormal electrocardiogram readings
Time frame: 4 weeks
Heart rate
Beats per minute
Time frame: 4 weeks
Blood pressure
mm Hg
Time frame: 4 weeks
Safety laboratory measurements
Number of participants with clinically significant abnormal laboratory values
Time frame: 4 weeks
Unified Dyskinesia Rating Scale (UDysRS)
The change from baseline to day 28 of treatment (Visit 4) in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The UDysRS is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
Time frame: 4 weeks
Unified Parkinson's Disease Rating Scale (UPDRS)
The UPDRS assess symptoms of Parkinson's disease. The scoring range from 0-199, where higher score means more severe disease.
Time frame: 4 weeks
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Parkinson Kinetigraph (PKG)
Wrist worn kinetigraph capturing electronic readings of movement activity.
Time frame: Change from run-in to week 4 of treatment
Clinical Global impression of change (CGI-C)
Global impression of change
Time frame: 4 weeks
Pharmacokinetic assessment
Plasma concentration at Cmax
Time frame: 4 weeks
Pharmacokinetic assessment
Trough level plasma concentration
Time frame: 4 weeks