Phase 3 Study of CVN424 (Parkinson's Disease) - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to find out if an experimental drug called CVN424 (the study drug) can help people diagnosed with advanced Parkinson's Disease (PD) who are on a stable dose of medication and continue to experience three of more hours of "OFF-time." OFF-time is a term that refers to the time when people experience PD symptoms between doses of medicine. We want to know if the study drug can reduce symptoms and lower that amount of time.

¿Cuál es la Condición que se está estudiando?

Advanced Parkinson's Disease (PD)

¿Quién puede participar en el Estudio?

Adults ages 30+ who:

  • Are diagnosed with Parkinson's Disease
  • Are treated with levodopa at least 4 times daily (immediate or controlled release C/L) or three times daily (Rytary)

For more information, contact the study team at karen.white@duke.edu.

Grupo etario
Adultos

¿Qué Implica?

If you choose to join this study, you will get a random assignment (fair, equal chance) to 1 of 3 groups to either:

  • Get a higher dose of the study drug
  • Get a lower dose of the study drug
  • Administre un placebo (sustancia inactiva que no contiene ningún medicamento)

The study drug and placebo are tablets that you will take once a day by mouth. You will take the study drug or placebo for 12 weeks.

Participation in the study will last up to 20 weeks. You will make 8 visits to our clinic for check-ups while you are in the study. During these visits, you will:

  • Someterse a exámenes físicos
  • Have neurological exams
  • Responder encuestas

We will also give you an electronic diary to use between visits to keep track of your symptoms.

Detalles del Estudio

Título Completo
Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson’s Disease Patients with Motor Complications
Investigador Principal
Especialista en neurología
Número de Protocolo
IRB: PRO00116429
NCT: NCT06553027
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción