Vista PD is a randomized, placebo-controlled, multicenter study to evaluate the efficacy, PK, safety, and tolerability of VIM0423 in adults with Parkinson's disease tremor insufficiently responsive to dopaminergic therapy.
The main objectives of this clinical trial are to determine the following:
* Does VIM0423 therapy improve tremor symptoms in adults with Parkinson's disease? * Is VIM0423 well tolerated in individuals with Parkinsons's disease? and * Do the therapeutic effects of VIM0423 confer improvements on daily function and quality of life?
Participant must be male or nonpregnant female between 18 and 65 years of age (inclusive) at Visit 1 (Screening).
Diagnosis of clinically probable or clinically established idiopathic Parkinson's disease (PD) at Visit 1 (Screening) established by the MDS 2015 criteria which must include tremor as one of the cardinal characteristics.
Cohort 1: Currently using levodopa (any oral form only) or oral dopamine agonist at a stable dose and regimen of at least 10 weeks prior to Visit 1 (Screening); with no anticipated changes to said therapies for the duration of the study; and on a minimum of 300 mg LEDD. Cohort 2: Individuals who are dopaminergic naïve, as defined by: no prior or ongoing usage of levodopa (in any form) or dopamine agonist (in any form), and no anticipated plans to initiate said therapies for the duration of the study.
The participants must meet protocol-specified requirements for baseline tremor scores.
Currently (within 7 days of Screening) taking any anticholinergic medication.
Prior deep brain stimulation (DBS) or any other form of invasive neurosurgical intervention (including, but not limited to, magnetic resonance-guided focused ultrasound thalamotomy, ablative thalamotomy, gamma knife thalamotomy)
Parallel
VIM0423
DrugVIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)
VIM0423 Placebo
DrugMatching VIM0423 placebo product containing no active ingredient
Change from baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS is a multi-part assessment designed to evaluate various aspects of PD and its impact on the individual, including motor and non-motor symptoms. There are four parts, all of which will be completed in this study: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part has varying maximum scores. In all cases, a higher score represents a more severe status.
Change from baseline in Clinical Global Impression of Severity (CGI-S) as assessed by the clinician
The CGI-S assesses the clinician's impression of the participant's current illness state. The clinician should use his/her total clinical experience with this population and rate the current severity of the participant's PD on a scale from 1 (normal, not at all ill) to 7 (among the most extremely ill).
Change from baseline in Tremor Research Group Essential Tremor Rating Scale - Activities of Daily Living (TETRAS-ADL)
The TETRAS-ADL is a standardized assessment of the impact of tremor on activities of daily living in individuals with essential tremor. There are 12 items: speaking; feeding with a spoon; drinking from a glass; hygiene; dressing; pouring; carrying food on trays, plates or similar items; using keys; writing; working; overall disability; social impact. Each item is scored 0 (normal) to 4 (severe/severely abnormal), for a total possible score of 48, with a higher score indicated a worse impact of tremor.
Clinical Global Impression of Change (CGI-C)
The CGI-C assesses the clinician's impression of how the participant's current illness has changed relative to baseline/pre-study. The clinician should use his/her total clinical experience with the individual participant and rate the participant's change in signs and reported symptoms using the scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), or 7 (very much worse).
Patient Global Impression of Change (PGI-C)
The PGI-C is a written scale which will be used to solicit the participant's self-report of overall difference in PD related symptoms compared to his/her pre-study baseline. The score for each timepoint will be: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), or 7 (very much worse).
Incidence and severity of treatment emergent adverse events (TEAEs)
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