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New pill aims to smooth out Parkinson's motor swings

NCT ID NCT07432958

Symptom relief Sponsor: Appello Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study tests an experimental drug called AP-472 in people with Parkinson's disease who have motor fluctuations—times when their usual levodopa medication stops working well. About 150 participants will take either a low dose, a high dose, or a placebo pill for 8 weeks, added to their regular levodopa. The goal is to see if AP-472 can increase the time they feel good and moving well (ON time) without causing unwanted side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AP-472
What this could lead to
If it works, this could lead to a new add-on treatment that helps Parkinson's patients spend more time in the 'ON' state with fewer movement problems.
What could go wrong
This is an early Phase 2 trial with only 150 people, so results may not apply to everyone. The drug may not reduce OFF time more than a placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Participants must meet all of the following criteria to take part in the study: 1. Be a man or woman between 30 and 80 years of age at the time of screening. 2. 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. 3. 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). 4. 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. 5. Have a Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening. 6. Be able to walk independently, with or without the use of a walking aid. 7. Be able to swallow oral medication. 8. 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. 9. 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). Key Exclusion Criteria: Participants cannot take part in the study if any of the following apply: 1. Have a form of parkinsonism that is not typical Parkinson's disease, such as secondary or atypical parkinsonism. 2. 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. 3. Have dyskinesias (involuntary movements) that are severe enough, in the study doctor's opinion, to interfere with participation. 4. Have a history of only certain types of dyskinesias (such as OFF-state, diphasic, myoclonic, or dystonic dyskinesias) without typical peak-dose dyskinesias. 5. Are currently taking medications that block dopamine, except for low-dose quetiapine (up to 50 mg per day) used for insomnia. 6. Routinely use on-demand "rescue" Parkinson's medications more than three times per week.

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Conditions

The condition(s) this trial relates to.

Dyskinesias Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asheville Neurology Specialists, P.A. (Site #229)

    RECRUITING

    Asheville, North Carolina, 28806, United States

  • Augusta University Medical Center (Site #212)

    RECRUITING

    Augusta, Georgia, 30912-0020, United States

  • Beth Israel Deaconess Medical Center (Site #211)

    RECRUITING

    Boston, Massachusetts, 02215-5400, United States

  • Central Texas Neurology Consultants (Site #203)

    RECRUITING

    Round Rock, Texas, 78681-3578, United States

  • Cleveland Clinic (Site #223)

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195-0001, United States

  • Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217)

    RECRUITING

    Los Alamitos, California, 90720-3108, United States

  • Duke Neurological Disorders Clinic (Site #210)

    RECRUITING

    Durham, North Carolina, 27705, United States

  • EvergreenHealth (Site #219)

    RECRUITING

    Kirkland, Washington, 98034-3013, United States

  • Horizon Clinical Research: Gill Neuroscience - Houston (Site #232)

    RECRUITING

    Cypress, Texas, 77429, United States

  • Joan and Sanford I. Weill Department of Medicine (Site #224)

    RECRUITING

    New York, New York, 10021, United States

  • Josephson Wallack Munshower Neurology PC (Site #231)

    RECRUITING

    Indianapolis, Indiana, 46256, United States

  • Keck Medicine of USC - USC Healthcare Center 2 (Site #221)

    NOT_YET_RECRUITING

    Los Angeles, California, 90033-5310, United States

  • Kentucky Neuroscience Institute (Site #213)

    RECRUITING

    Lexington, Kentucky, 40536-0001, United States

  • Mount Sinai School of Medicine (Site #209)

    RECRUITING

    New York, New York, 10029-6501, United States

  • Neurology One (Site #205)

    RECRUITING

    Orlando, Florida, 32825, United States

  • Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227)

    RECRUITING

    Boca Raton, Florida, 33486, United States

  • Parkinson's Research Centers of America (Site #218)

    RECRUITING

    Palo Alto, California, 94301, United States

  • Profound Research LLC (Site #222)

    RECRUITING

    Carlsbad, California, 92011, United States

  • Quest Research Institute - Alcanza - PPDS (Site #201)

    RECRUITING

    Farmington Hills, Michigan, 48334-2973, United States

  • Rocky Mountain Clinical Research - CenExel - PPDS (Site #215)

    RECRUITING

    Englewood, Colorado, 80113-2776, United States

  • The Ohio State University Wexner Medical Center (site #207)

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Kansas (KU) (Site #216)

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • UM-UHealth at Boca Raton (Site #226)

    RECRUITING

    Boca Raton, Florida, 33486, United States

  • USF Parkinson's Disease and Movement Disorders Center (Site #206)

    RECRUITING

    Tampa, Florida, 33613-4808, United States

  • University of Arkansas for Medical Sciences (Site #208)

    NOT_YET_RECRUITING

    Little Rock, Arkansas, 72205-5551, United States

  • University of Miami (Site #220)

    RECRUITING

    Miami, Florida, 33136-1051, United States

  • University of Michigan Health System (UMHS) (Site #202)

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of New Mexico Health Sciences Center (Site #225)

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • Vanderbilt University Medical Center (Site #204)

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Velocity Clinical Research - Hallandale Beach (Site #228)

    RECRUITING

    Hallandale, Florida, 33009, United States

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