A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia
|ClinicalTrials.gov Identifier: NCT03531060|
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: IRL790 Drug: Placebo||Phase 1 Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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).|
|Actual Study Start Date :||November 8, 2016|
|Actual Primary Completion Date :||April 12, 2017|
|Actual Study Completion Date :||April 12, 2017|
IRL790 Capsule 10 mg, oral administration
IRL790 capsule 10 mg
Placebo Comparator: Placebo
Placebo capsule, identical appearance, oral administration
- Adverse Events [ Time Frame: 4 weeks ]Medical Dictionary for Regulatory Activities Preferred Term
- Physical examination [ Time Frame: 4 weeks ]Number of participants with clinically significant abnormal physical examination findings
- Electrocardiogram (ECG) recordings [ Time Frame: 4 weeks ]Number of participants with clinically significant abnormal electrocardiogram readings
- Heart rate [ Time Frame: 4 weeks ]Beats per minute
- Blood pressure [ Time Frame: 4 weeks ]mm Hg
- Safety laboratory measurements [ Time Frame: 4 weeks ]Number of participants with clinically significant abnormal laboratory values
- Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 4 weeks ]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.
- Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 4 weeks ]The UPDRS assess symptoms of Parkinson's disease. The scoring range from 0-199, where higher score means more severe disease.
- Parkinson Kinetigraph (PKG) [ Time Frame: Change from run-in to week 4 of treatment ]Wrist worn kinetigraph capturing electronic readings of movement activity.
- Clinical Global impression of change (CGI-C) [ Time Frame: 4 weeks ]Global impression of change
- Pharmacokinetic assessment [ Time Frame: 4 weeks ]Plasma concentration at Cmax
- Pharmacokinetic assessment [ Time Frame: 4 weeks ]Trough level plasma concentration
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531060
|Principal Investigator:||Per Svenningsson, MD, PhD||Karolinska Institutet, Stockholm|