VIM0423 for Parkinson's Tremor in Adults Not Fully Controlled by Dopaminergic Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, placebo-controlled study evaluates the efficacy, pharmacokinetics, safety, and tolerability of VIM0423 in adults with Parkinson’s disease tremor that remains inadequately controlled by dopaminergic therapy. Participants are enrolled at multiple centers and randomized to receive VIM0423 or placebo to see if tremor improves and whether daily function and quality of life are affected. The trial includes two cohorts: dopaminergic users on stable therapy and dopaminergic-naïve participants, to explore different patient experiences with the drug. Safety and tolerability are monitored closely, with PK analyses to understand how the drug behaves in the body.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vima Site #048
  Murrieta, California, United States Recruiting
• Vima Site #045
  Decatur, Georgia, United States Recruiting
• Vima Site #002
  Farmington Hills, Michigan, United States Recruiting
• Vima Site #016
  Memphis, Tennessee, United States Recruiting
• Vima Site #039
  Scottsdale, Arizona, United States Not yet recruiting
• Vima Site #064
  Scottsdale, Arizona, United States Not yet recruiting

Study contacts

• Study coordinator: Study Director
• Email: Clinicaltrials@vimatx.com
• Phone: 617-430-7027

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.