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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2026-08-11)

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

๐ŸŸข Recruiting Phase 2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Appello Pharmaceuticals, Inc.

๐Ÿฉบ Protocol 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.

Primary Research Facility: University of Arkansas for Medical Sciences (Site #208) (Little Rock, Arkansas)

๐Ÿ“‹ Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

๐Ÿ“ Primary Site Map

Site: University of Arkansas for Medical Sciences (Site #208) โ€” Little Rock, Arkansas

๐Ÿ“ All Participating Trial Locations (30 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. University of Arkansas for Medical Sciences (Site #208) โ€” Little Rock, Arkansas
2. Profound Research LLC (Site #222) โ€” Carlsbad, California
3. Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217) โ€” Los Alamitos, California
4. Keck Medicine of USC - USC Healthcare Center 2 (Site #221) โ€” Los Angeles, California
5. Parkinson's Research Centers of America (Site #218) โ€” Palo Alto, California
6. Rocky Mountain Clinical Research - CenExel - PPDS (Site #215) โ€” Englewood, Colorado
7. Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227) โ€” Boca Raton, Florida
8. UM-UHealth at Boca Raton (Site #226) โ€” Boca Raton, Florida
9. Velocity Clinical Research - Hallandale Beach (Site #228) โ€” Hallandale, Florida
10. University of Miami (Site #220) โ€” Miami, Florida
11. Neurology One (Site #205) โ€” Orlando, Florida
12. USF Parkinson's Disease and Movement Disorders Center (Site #206) โ€” Tampa, Florida
13. Augusta University Medical Center (Site #212) โ€” Augusta, Georgia
14. Josephson Wallack Munshower Neurology PC (Site #231) โ€” Indianapolis, Indiana
15. The University of Kansas (KU) (Site #216) โ€” Kansas City, Kansas
16. Kentucky Neuroscience Institute (Site #213) โ€” Lexington, Kentucky
17. Beth Israel Deaconess Medical Center (Site #211) โ€” Boston, Massachusetts
18. University of Michigan Health System (UMHS) (Site #202) โ€” Ann Arbor, Michigan
19. Quest Research Institute - Alcanza - PPDS (Site #201) โ€” Farmington Hills, Michigan
20. University of New Mexico Health Sciences Center (Site #225) โ€” Albuquerque, New Mexico
21. Joan and Sanford I. Weill Department of Medicine (Site #224) โ€” New York, New York
22. Mount Sinai School of Medicine (Site #209) โ€” New York, New York
23. Asheville Neurology Specialists, P.A. (Site #229) โ€” Asheville, North Carolina
24. Duke Neurological Disorders Clinic (Site #210) โ€” Durham, North Carolina
25. Cleveland Clinic (Site #223) โ€” Cleveland, Ohio

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๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT07432958 โ€ข Last Synced: 2026-08-11
View on ClinicalTrials.gov โ†—
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