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
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT07432958
- Run by
- Appello Pharmaceuticals, Inc.
- People needed
- 150
- Starts
- 2026-02-25
- Expected to finish
- 2028-01-03
- Last updated by the study team
- 2026-07-20
Who can join
Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- EvergreenHealth (Site #219) — Kirkland, Washington, United States (enrolling)
- Profound Research LLC (Site #222) — Carlsbad, California, United States (enrolling)
- Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217) — Los Alamitos, California, United States (enrolling)
- Parkinson's Research Centers of America (Site #218) — Palo Alto, California, United States (enrolling)
- Rocky Mountain Clinical Research - CenExel - PPDS (Site #215) — Englewood, Colorado, United States (enrolling)
- Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227) — Boca Raton, Florida, United States (enrolling)
- Velocity Clinical Research - Hallandale Beach (Site #228) — Hallandale, Florida, United States (enrolling)
- Neurology One (Site #205) — Orlando, Florida, United States (enrolling)
- The University of Kansas (KU) (Site #216) — Kansas City, Kansas, United States (enrolling)
- Kentucky Neuroscience Institute (Site #213) — Lexington, Kentucky, United States (enrolling)
- Quest Research Institute - Alcanza - PPDS (Site #201) — Farmington Hills, Michigan, United States (enrolling)
- University of New Mexico Health Sciences Center (Site #225) — Albuquerque, New Mexico, United States (enrolling)
- Mount Sinai School of Medicine (Site #209) — New York, New York, United States (enrolling)
- Asheville Neurology Specialists, P.A. (Site #229) — Asheville, North Carolina, United States (enrolling)
- The Ohio State University Wexner Medical Center (site #207) — Columbus, Ohio, United States (enrolling)
- Central Texas Neurology Consultants (Site #203) — Round Rock, Texas, United States (enrolling)
- Beth Israel Deaconess Medical Center (Site #211) — Boston, Massachusetts, United States
- Keck Medicine of USC - USC Healthcare Center 2 (Site #221) — Los Angeles, California, United States
- University of Michigan Health System (UMHS) (Site #202) — Ann Arbor, Michigan, United States
- Cleveland Clinic (Site #223) — Cleveland, Ohio, United States
- University of Arkansas for Medical Sciences (Site #208) — Little Rock, Arkansas, United States
- UM-UHealth at Boca Raton (Site #226) — Boca Raton, Florida, United States
- Joan and Sanford I. Weill Department of Medicine (Site #224) — New York, New York, United States
- University of Miami (Site #220) — Miami, Florida, United States
- Vanderbilt University Medical Center (Site #204) — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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