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NCT07432958PHASE2Recruiting

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

Appello Pharmaceuticals, Inc.

Start Date

2/25/2026

Completion Date

1/3/2028

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 Criteria

Age Range: 30 years to 80 years

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.

Interventions

DRUG

AP-472

OTHER

Placebo

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Conditions

Parkinson Disease

Locations

University of Arkansas for Medical Sciences (Site #208)

Little Rock, Arkansas 72205-5551

United States

Profound Research LLC (Site #222)

Carlsbad, California 92011

United States

Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217)

Los Alamitos, California 90720-3108

United States

Keck Medicine of USC - USC Healthcare Center 2 (Site #221)

Los Angeles, California 90033-5310

United States

Parkinson's Research Centers of America (Site #218)

Palo Alto, California 94301

United States

Rocky Mountain Clinical Research - CenExel - PPDS (Site #215)

Englewood, Colorado 80113-2776

United States

Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227)

Boca Raton, Florida 33486

United States

UM-UHealth at Boca Raton (Site #226)

Boca Raton, Florida 33486

United States

Velocity Clinical Research - Hallandale Beach (Site #228)

Hallandale, Florida 33009

United States

University of Miami (Site #220)

Miami, Florida 33136-1051

United States

Neurology One (Site #205)

Orlando, Florida 32825

United States

USF Parkinson's Disease and Movement Disorders Center (Site #206)

Tampa, Florida 33613-4808

United States

Augusta University Medical Center (Site #212)

Augusta, Georgia 30912-0020

United States

Josephson Wallack Munshower Neurology PC (Site #231)

Indianapolis, Indiana 46256

United States

The University of Kansas (KU) (Site #216)

Kansas City, Kansas 66160

United States

Kentucky Neuroscience Institute (Site #213)

Lexington, Kentucky 40536-0001

United States

Beth Israel Deaconess Medical Center (Site #211)

Boston, Massachusetts 02215-5400

United States

University of Michigan Health System (UMHS) (Site #202)

Ann Arbor, Michigan 48109

United States

Quest Research Institute - Alcanza - PPDS (Site #201)

Farmington Hills, Michigan 48334-2973

United States

University of New Mexico Health Sciences Center (Site #225)

Albuquerque, New Mexico 87106

United States

Joan and Sanford I. Weill Department of Medicine (Site #224)

New York, New York 10021

United States

Mount Sinai School of Medicine (Site #209)

New York, New York 10029-6501

United States

Asheville Neurology Specialists, P.A. (Site #229)

Asheville, North Carolina 28806

United States

Duke Neurological Disorders Clinic (Site #210)

Durham, North Carolina 27705

United States

Cleveland Clinic (Site #223)

Cleveland, Ohio 44195-0001

United States

The Ohio State University Wexner Medical Center (site #207)

Columbus, Ohio 43210

United States

Vanderbilt University Medical Center (Site #204)

Nashville, Tennessee 37232

United States

Horizon Clinical Research: Gill Neuroscience - Houston (Site #232)

Cypress, Texas 77429

United States

Central Texas Neurology Consultants (Site #203)

Round Rock, Texas 78681-3578

United States

EvergreenHealth (Site #219)

Kirkland, Washington 98034-3013

United States