AP-472 added to levodopa for Parkinson's disease with motor fluctuations

Trial details

Who runs it

Appello Pharmaceuticals, Inc.

Trial code

NCT07432958

Record updated

28 October 2026

Original description

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.Read full original descriptionShow less

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

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 14 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 a 12-week treatment period. During the treatment period, limited adjustments to levodopa are allowed if needed.

Inclusion: 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).

Exclusion: 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; 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; Have a form of parkinsonism that is not typical Parkinson's disease, such as secondary or atypical parkinsonism; Have a history of only certain types of dyskinesias (such as OFF-state, diphasic, myoclonic, or dystonic dyskinesias) without typical peak-dose dyskinesias; Participants cannot take part in the study if any of the following apply:; Have dyskinesias (involuntary movements) that are severe enough, in the study doctor's opinion, to interfere with participation.

ClinicalTrials.gov NCT07432958