Actively Recruiting
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
Led by Appello Pharmaceuticals, Inc. · Updated on 2026-04-06
150
Participants Needed
25
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 30 to 80 years at screening
- Diagnosis of Parkinson's disease with slowness of movement and one side affected more
- Mild to moderate Parkinson's disease (Hoehn and Yahr stage 3 or lower when medications work)
- Average of at least 3 hours of daily OFF time, with at least 2.5 hours during baseline
- Montreal Cognitive Assessment score of 24 or higher at screening
- Able to walk independently, with or without a walking aid
- Able to swallow oral medication
- Stable Parkinson's medication regimen for at least 4 weeks before screening; MAO-B inhibitors stable for at least 12 weeks
- Taking levodopa at least four times daily (immediate- or controlled-release) or three times daily (extended-release)
You will not qualify if you...
- Have a form of parkinsonism that is not typical Parkinson's disease (such as secondary or atypical parkinsonism)
- Have received or plan to receive advanced Parkinson's therapies like continuous levodopa or dopamine delivery systems, or Parkinson's-related brain surgery
- Have severe dyskinesias interfering with participation
- Have only certain types of dyskinesias without typical peak-dose dyskinesias
- Currently taking dopamine-blocking medications except low-dose quetiapine (up to 50 mg daily) for insomnia
- Routinely use on-demand "rescue" Parkinson's medications more than three times per week
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205-5551
Not Yet Recruiting
2
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS
Los Alamitos, California, United States, 90720-3108
Not Yet Recruiting
3
Keck Medicine of USC - USC Healthcare Center 2
Los Angeles, California, United States, 90033-5310
Not Yet Recruiting
4
North County Neurology Associates
Oceanside, California, United States, 92056-4454
Not Yet Recruiting
5
Parkinson's Research Centers of America
Palo Alto, California, United States, 94301
Not Yet Recruiting
6
Rocky Mountain Clinical Research - CenExel - PPDS
Englewood, Colorado, United States, 80113-2776
Not Yet Recruiting
7
University of Miami
Miami, Florida, United States, 33136-1051
Not Yet Recruiting
8
Neurology One
Orlando, Florida, United States, 32825
Not Yet Recruiting
9
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33613-4808
Not Yet Recruiting
10
Augusta University Medical Center
Augusta, Georgia, United States, 30912-0020
Not Yet Recruiting
11
The University of Kansas (KU)
Kansas City, Kansas, United States, 66103-2078
Not Yet Recruiting
12
Kentucky Neuroscience Institute
Lexington, Kentucky, United States, 40536-0001
Not Yet Recruiting
13
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215-5400
Not Yet Recruiting
14
University of Michigan Health System (UMHS)
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
15
Quest Research Institute - Alcanza - PPDS
Farmington Hills, Michigan, United States, 48334-2973
Actively Recruiting
16
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131-0001
Not Yet Recruiting
17
Mount Sinai School of Medicine
New York, New York, United States, 10029-6501
Not Yet Recruiting
18
Joan and Sanford I. Weill Department of Medicine
New York, New York, United States, 10065
Not Yet Recruiting
19
Duke Neurological Disorders Clinic
Durham, North Carolina, United States, 27705
Not Yet Recruiting
20
Cleveland Clinic
Cleveland, Ohio, United States, 44195-0001
Not Yet Recruiting
21
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43202-4500
Not Yet Recruiting
22
Movement Disorder Clinic of Oklahoma PLLC
Tulsa, Oklahoma, United States, 74136-7027
Not Yet Recruiting
23
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
24
Central Texas Neurology Consultants
Round Rock, Texas, United States, 78681-3578
Actively Recruiting
25
EvergreenHealth
Kirkland, Washington, United States, 98034-3013
Not Yet Recruiting
Research Team
A
Annie Blobaum, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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