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Recruiting 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 II Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AP-472, Placebo.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug AP-472
    Oral tablet
  • Other Placebo
    Oral tablet

Primary outcome measures

  • Change from Baseline in average daily OFF time on motor diaries for AP-472 compared to placebo (normalized to 16-hour awake time) [Time frame: Week 12]
Secondary outcome measures (5)
  • Change from baseline in ON time without troublesome dyskinesia (normalized to 16 hours) [Time frame: Week 12]
  • Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 2 (Motor Experiences of Daily Living (M-EDL)) score [Time frame: Week 12]
  • Change from baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index [Time frame: Week 12]
  • Change from baseline in MDS-UPDRS Part III (Motor Examination) score in the best ON state [Time frame: Week 12]
  • Change from baseline in Epworth Sleepiness Scale (ESS) total score [Time frame: Week 12]

Eligibility criteria

Inclusion criteria

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 criteria

Participants cannot take part in the study if any of the following apply:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 30 centers
  • University of Arkansas for Medical Sciences (Site #208) — Little Rock
  • Profound Research LLC (Site #222) — Carlsbad
  • Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217) — Los Alamitos
  • Keck Medicine of USC - USC Healthcare Center 2 (Site #221) — Los Angeles
  • Parkinson's Research Centers of America (Site #218) — Palo Alto
  • Rocky Mountain Clinical Research - CenExel - PPDS (Site #215) — Englewood
  • Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227) — Boca Raton
  • UM-UHealth at Boca Raton (Site #226) — Boca Raton
  • … and 22 more centers

Identifiers

NCT: NCT07432958 · APLO-1201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗