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RECRUITING

NCT07432958

PHASE2

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

Sponsor: Appello Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Official title: Phase 2, Double-blind, Placebo-controlled 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

Key Details

Gender

All

Age Range

30 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-02-25

Completion Date

2028-01-03

Last Updated

2026-08-11

Healthy Volunteers

Conditions

Parkinson Disease

Interventions

DRUG

AP-472

Oral tablet

OTHER

Placebo

Oral tablet

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.

Locations (30)

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