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

Sponsored by Vima Therapeutics

About this study

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?

Parkinson's disease (PD) is the second most common neurodegenerative condition, with studies estimating US prevalence among individuals aged 45 years and older rising to approximately 1,238,000 by 2030. More than 75% of individuals with PD will experience resting tremor at some point during their disease course, and approximately 60% additionally suffer from a symptomatic tremor during action or movement, complicating functional tasks. The distress caused by PD tremor is profound, with individuals consistently identifying it as their "most bothersome" symptom in early disease, and more impactful than other motor and nonmotor symptoms. Despite the clear importance of this symptom to patient experience, significant unmet need in tremor management persists. Tremor-specific efficacy of dopami…

Where this study is enrolling (29)

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Who can participate

Inclusion criteria

  • ✓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.

Exclusion criteria

  • ✕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)
  • ✕Other protocol-specified inclusion and exclusion criteria may apply.

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Trial data sourced from ClinicalTrials.gov.