A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Vima Therapeutics · Industry
Who this trial is looking for
This trial is looking for adults with Parkinson's disease who have tremors that are not well-managed with current treatments. Participants will be given a study medication to see if it helps improve their symptoms and daily life.
Are You a Good Fit for This Trial?
Must be takingLevodopaDopamine agonist
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with Parkinson's disease that includes tremors.
I have been using levodopa or a dopamine agonist for at least 10 weeks OR I have never used these medications.
I am stable on my current medication without expected changes.
You may not be able to join if
I have taken any anticholinergic medication in the past 7 days.
I have had deep brain stimulation or other invasive surgery for Parkinson's.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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…
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?
Trial Locations
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Eligibility Criteria
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 m…
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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