A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations
Recruiting · NCT07432958 · Interventional (participants receive a specific treatment) · Lead sponsor: Appello Pharmaceuticals, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
AP-472Placebo
What this trial is about
This is a Phase 2 study in people with Parkinson's disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo. The study will last about 12 weeks. Participants will be randomly assigned to receive one of the two doses of AP-472 or a placebo. Neither the participants nor the study staff will know which treatment is given. The study includes a screening period, a 4-week period during which Parkinson's medications must remain stable, and an 8-week treatment period. During the treatment period, limited adjustments to levodopa are allowed if needed.
Who can take part
Age range
30 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participants must meet all of the following criteria to take part in the study:
- Be a man or woman between 30 and 80 years of age at the time of screening.
- Have a diagnosis of Parkinson's disease, confirmed using standard medical criteria, including slowness of movement and symptoms that affect one side of the body more than the other.
- Have mild to moderate Parkinson's disease, defined as stage 3 or lower on the Hoehn and Yahr scale when medications are working ("ON" state).
- Experience an average of at least 3 hours of OFF time per day, based on home symptom diaries, with at least 2.5 hours of OFF time each day during the baseline period.
- Have a Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening.
- Be able to walk independently, with or without the use of a walking aid.
- Be able to swallow oral medication.
- Have been on a stable Parkinson's medication regimen for at least 4 weeks before screening. Medications known as MAO-B inhibitors must have been stable for at least 12 weeks.
- Be taking levodopa at least four times daily (immediate- or controlled-release formulations) or three times daily (extended-release formulations such as Rytary or Crexont).
- Key
Exclusion criteria
- Participants cannot take part in the study if any of the following apply:
- Have a form of parkinsonism that is not typical Parkinson's disease, such as secondary or atypical parkinsonism.
- Have previously received, or plan to receive during the study, advanced Parkinson's therapies such as continuous levodopa or dopamine delivery systems, or Parkinson's disease-related brain surgery.
- Have dyskinesias (involuntary movements) that are severe enough, in the study doctor's opinion, to interfere with participation.
- Have a history of only certain types of dyskinesias (such as OFF-state, diphasic, myoclonic, or dystonic dyskinesias) without typical peak-dose dyskinesias.
- Are currently taking medications that block dopamine, except for low-dose quetiapine (up to 50 mg per day) used for insomnia.
- Routinely use on-demand "rescue" Parkinson's medications more than three times per week.
Where it is running
30 locations listed across 17 US states.
- University of Arkansas for Medical Sciences (Site #208) - Little Rock, Arkansas, United States
- Profound Research LLC (Site #222) - Carlsbad, California, United States
- Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217) - Los Alamitos, California, United States
- Keck Medicine of USC - USC Healthcare Center 2 (Site #221) - Los Angeles, California, United States
- Parkinson's Research Centers of America (Site #218) - Palo Alto, California, United States
- Rocky Mountain Clinical Research - CenExel - PPDS (Site #215) - Englewood, Colorado, United States
- Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227) - Boca Raton, Florida, United States
- UM-UHealth at Boca Raton (Site #226) - Boca Raton, Florida, United States
- Velocity Clinical Research - Hallandale Beach (Site #228) - Hallandale, Florida, United States
- University of Miami (Site #220) - Miami, Florida, United States
- Neurology One (Site #205) - Orlando, Florida, United States
- USF Parkinson's Disease and Movement Disorders Center (Site #206) - Tampa, Florida, United States
- Augusta University Medical Center (Site #212) - Augusta, Georgia, United States
- Josephson Wallack Munshower Neurology PC (Site #231) - Indianapolis, Indiana, United States
- The University of Kansas (KU) (Site #216) - Kansas City, Kansas, United States
- Kentucky Neuroscience Institute (Site #213) - Lexington, Kentucky, United States
- Beth Israel Deaconess Medical Center (Site #211) - Boston, Massachusetts, United States
- University of Michigan Health System (UMHS) (Site #202) - Ann Arbor, Michigan, United States
- Quest Research Institute - Alcanza - PPDS (Site #201) - Farmington Hills, Michigan, United States
- University of New Mexico Health Sciences Center (Site #225) - Albuquerque, New Mexico, United States
- Joan and Sanford I. Weill Department of Medicine (Site #224) - New York, New York, United States
- Mount Sinai School of Medicine (Site #209) - New York, New York, United States
- Asheville Neurology Specialists, P.A. (Site #229) - Asheville, North Carolina, United States
- Duke Neurological Disorders Clinic (Site #210) - Durham, North Carolina, United States
- Cleveland Clinic (Site #223) - Cleveland, Ohio, United States
- The Ohio State University Wexner Medical Center (site #207) - Columbus, Ohio, United States
- Vanderbilt University Medical Center (Site #204) - Nashville, Tennessee, United States
- Horizon Clinical Research: Gill Neuroscience - Houston (Site #232) - Cypress, Texas, United States
- Central Texas Neurology Consultants (Site #203) - Round Rock, Texas, United States
- EvergreenHealth (Site #219) - Kirkland, Washington, United States