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Clinical Trials in the USA / NCT07432958
Recruiting Phase 2

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

NCT07432958 · tracked via the Priya Life Science USA tracker
Sponsor
Appello Pharmaceuticals, Inc.
Phase
Phase 2
Started
2026-02-25
Last updated
2026-09-10

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

AP-472Placebo

AP-472: Oral tablet

Placebo: Oral tablet

Study summary

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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
Key Inclusion Criteria: Participants must meet all of the following criteria to take part in the study: 1. Be a man or woman between 30 and 80 years of age at the time of screening. 2. 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. 3. 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). 4. 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. 5. Have a Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening. 6. Be able to walk independently, with or without the use of a walking aid. 7. Be able to swallow oral medication. 8. 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. 9. 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: 1. Have a form of parkinsonism that is not typical Parkinson's disease, such as secondary or atypical parkinsonism. 2. 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. 3. Have dyskinesias (involuntary movements) that are severe enough, in the study doctor's opinion, to interfere with participation. 4. Have a history of only certain types of dyskinesias (such as OFF-state, diphasic, myoclonic, or dystonic dyskinesias) without typical peak-dose dyskinesias. 5. Are currently taking medications that block dopamine, except for low-dose quetiapine (up to 50 mg per day) used for insomnia. 6. Routinely use on-demand "rescue" Parkinson's medications more than three times per week.

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
University of Arkansas for Medical Sciences (Site #208) Little Rock Arkansas Not Yet Recruiting
Profound Research LLC (Site #222) Carlsbad California Recruiting
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217) Los Alamitos California Recruiting
Keck Medicine of USC - USC Healthcare Center 2 (Site #221) Los Angeles California Not Yet Recruiting
Parkinson's Research Centers of America (Site #218) Palo Alto California Recruiting
Rocky Mountain Clinical Research - CenExel - PPDS (Site #215) Englewood Colorado Recruiting
Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227) Boca Raton Florida Recruiting
UM-UHealth at Boca Raton (Site #226) Boca Raton Florida Recruiting
Velocity Clinical Research - Hallandale Beach (Site #228) Hallandale Florida Recruiting
University of Miami (Site #220) Miami Florida Recruiting
Neurology One (Site #205) Orlando Florida Recruiting
USF Parkinson's Disease and Movement Disorders Center (Site #206) Tampa Florida Recruiting
Augusta University Medical Center (Site #212) Augusta Georgia Recruiting
Josephson Wallack Munshower Neurology PC (Site #231) Indianapolis Indiana Recruiting
The University of Kansas (KU) (Site #216) Kansas City Kansas Recruiting
Kentucky Neuroscience Institute (Site #213) Lexington Kentucky Recruiting
Beth Israel Deaconess Medical Center (Site #211) Boston Massachusetts Recruiting
University of Michigan Health System (UMHS) (Site #202) Ann Arbor Michigan Recruiting
Quest Research Institute - Alcanza - PPDS (Site #201) Farmington Hills Michigan Recruiting
University of New Mexico Health Sciences Center (Site #225) Albuquerque New Mexico Recruiting
Joan and Sanford I. Weill Department of Medicine (Site #224) New York New York Recruiting
Mount Sinai School of Medicine (Site #209) New York New York Recruiting
Asheville Neurology Specialists, P.A. (Site #229) Asheville North Carolina Recruiting
Duke Neurological Disorders Clinic (Site #210) Durham North Carolina Recruiting
Cleveland Clinic (Site #223) Cleveland Ohio Not Yet Recruiting
The Ohio State University Wexner Medical Center (site #207) Columbus Ohio Recruiting
Vanderbilt University Medical Center (Site #204) Nashville Tennessee Recruiting
Horizon Clinical Research: Gill Neuroscience - Houston (Site #232) Cypress Texas Recruiting
Central Texas Neurology Consultants (Site #203) Round Rock Texas Recruiting
EvergreenHealth (Site #219) Kirkland Washington Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07432958 on ClinicalTrials.gov ↗ ← All trials in the USA