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
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
1 other identifier
interventional
150
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 parkinson-disease
Started Mar 2026
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedStudy Start
First participant enrolled
March 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 3, 2028
February 25, 2026
February 1, 2026
1.5 years
January 29, 2026
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Change from baseline in ON time without troublesome dyskinesia (normalized to 16 hours)
Week 12
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 2 (Motor Experiences of Daily Living (M-EDL)) score
Week 12
Change from baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index
Week 12
Change from baseline in MDS-UPDRS Part III (Motor Examination) score in the best ON state
Week 12
Change from baseline in Epworth Sleepiness Scale (ESS) total score
Week 12
Study Arms (3)
Low Dose
EXPERIMENTALAP-472 100 mg per day
High Dose
EXPERIMENTALAP-472 300 mg per day
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205-5551, United States
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS
Los Alamitos, California, 90720-3108, United States
Keck Medicine of USC - USC Healthcare Center 2
Los Angeles, California, 90033-5310, United States
North County Neurology Associates
Oceanside, California, 92056-4454, United States
Parkinson's Research Centers of America
Palo Alto, California, 94301, United States
Rocky Mountain Clinical Research - CenExel - PPDS
Englewood, Colorado, 80113-2776, United States
University of Miami
Miami, Florida, 33136-1051, United States
Neurology One
Orlando, Florida, 32825, United States
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, 33613-4808, United States
Augusta University Medical Center
Augusta, Georgia, 30912-0020, United States
The University of Kansas (KU)
Kansas City, Kansas, 66103-2078, United States
Kentucky Neuroscience Institute
Lexington, Kentucky, 40536-0001, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215-5400, United States
University of Michigan Health System (UMHS)
Ann Arbor, Michigan, 48109, United States
Quest Research Institute - Alcanza - PPDS
Farmington Hills, Michigan, 48334-2973, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131-0001, United States
Mount Sinai School of Medicine
New York, New York, 10029-6501, United States
Joan and Sanford I. Weill Department of Medicine
New York, New York, 10065, United States
Duke Neurological Disorders Clinic
Durham, North Carolina, 27705, United States
Cleveland Clinic
Cleveland, Ohio, 44195-0001, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43202-4500, United States
Movement Disorder Clinic of Oklahoma PLLC
Tulsa, Oklahoma, 74136-7027, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Central Texas Neurology Consultants
Round Rock, Texas, 78681-3578, United States
EvergreenHealth
Kirkland, Washington, 98034-3013, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2026
First Posted
February 25, 2026
Study Start
March 9, 2026
Primary Completion (Estimated)
September 3, 2027
Study Completion (Estimated)
January 3, 2028
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share