A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

VIM0423: VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)

VIM0423 Placebo: Matching VIM0423 placebo product containing no active ingredient

Study summary

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?

Eligibility

Primary outcome measure(s)

• Change from baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) — From baseline to Week 6
  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.

Trial sites (30)