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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 · Appello Pharmaceuticals, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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
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.
Study design
Enrollment target: 150 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-02-25
Estimated completion: 2028-01-03
Last updated: 2026-04-06
Interventions
Drug: AP-472Other: Placebo
Primary outcomes
- • Change from Baseline in average daily OFF time on motor diaries for AP-472 compared to placebo (normalized to 16-hour awake time) (Week 12)
Sponsor
Appello Pharmaceuticals, Inc. · industry
Contacts & investigators
ContactAnnie Blobaum, Ph.D. · contact · annie@appellopharma.com · 615-427-1935
All locations (25)
University of Arkansas for Medical SciencesNot Yet Recruiting
Little Rock, Arkansas, United States
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDSNot Yet Recruiting
Los Alamitos, California, United States
Keck Medicine of USC - USC Healthcare Center 2Not Yet Recruiting
Los Angeles, California, United States
North County Neurology AssociatesNot Yet Recruiting
Oceanside, California, United States
Parkinson's Research Centers of AmericaNot Yet Recruiting
Palo Alto, California, United States
Rocky Mountain Clinical Research - CenExel - PPDSNot Yet Recruiting
Englewood, Colorado, United States
University of MiamiNot Yet Recruiting
Miami, Florida, United States
Neurology OneNot Yet Recruiting
Orlando, Florida, United States
USF Parkinson's Disease and Movement Disorders CenterNot Yet Recruiting
Tampa, Florida, United States
Augusta University Medical CenterNot Yet Recruiting
Augusta, Georgia, United States
The University of Kansas (KU)Not Yet Recruiting
Kansas City, Kansas, United States
Kentucky Neuroscience InstituteNot Yet Recruiting
Lexington, Kentucky, United States
Beth Israel Deaconess Medical CenterNot Yet Recruiting
Boston, Massachusetts, United States
University of Michigan Health System (UMHS)Not Yet Recruiting
Ann Arbor, Michigan, United States
Quest Research Institute - Alcanza - PPDSRecruiting
Farmington Hills, Michigan, United States
University of New Mexico Health Sciences CenterNot Yet Recruiting
Albuquerque, New Mexico, United States
Mount Sinai School of MedicineNot Yet Recruiting
New York, New York, United States
Joan and Sanford I. Weill Department of MedicineNot Yet Recruiting
New York, New York, United States
Duke Neurological Disorders ClinicNot Yet Recruiting
Durham, North Carolina, United States
Cleveland ClinicNot Yet Recruiting
Cleveland, Ohio, United States
The Ohio State University Wexner Medical CenterNot Yet Recruiting
Columbus, Ohio, United States
Movement Disorder Clinic of Oklahoma PLLCNot Yet Recruiting
Tulsa, Oklahoma, United States
Vanderbilt University Medical CenterNot Yet Recruiting
Nashville, Tennessee, United States
Central Texas Neurology ConsultantsRecruiting
Round Rock, Texas, United States
EvergreenHealthNot Yet Recruiting
Kirkland, Washington, United States