NCT07432958

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Appello Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	AP-472	Oral tablet
OTHER	Placebo	Oral tablet

Timeline

• Start date: 2026-02-25
• Primary completion: 2027-09-03
• Completion: 2028-01-03
• First posted: 2026-02-25
• Last updated: 2026-04-06

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study