Parkinson DiseasePhase 2NCT07432958
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
A Phase 2 study testing AP-472 in people with Parkinson Disease, run by Appello Pharmaceuticals, Inc. at 30 sites in United States.
Trial 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 14 weeks. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- AP-472
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 30 sitesUnited States
- Study dates
- 25 Feb 2026to 3 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
United States30 sites, 30 recruiting
- Recruiting
University of New Mexico Health Sciences Center (Site #225)
Albuquerque, New Mexico, 87106
- Recruiting
University of Michigan Health System (UMHS) (Site #202)
Ann Arbor, Michigan, 48109
- Recruiting
Asheville Neurology Specialists, P.A. (Site #229)
Asheville, North Carolina, 28806
- Recruiting
Augusta University Medical Center (Site #212)
Augusta, Georgia, 30912-0020
- Recruiting
Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227)
Boca Raton, Florida, 33486
- Recruiting
UM-UHealth at Boca Raton (Site #226)
Boca Raton, Florida, 33486
- Recruiting
Beth Israel Deaconess Medical Center (Site #211)
Boston, Massachusetts, 02215-5400
- Recruiting
Profound Research LLC (Site #222)
Carlsbad, California, 92011
- Recruiting
Cleveland Clinic (Site #223)
Cleveland, Ohio, 44195-0001
- Recruiting
The Ohio State University Wexner Medical Center (site #207)
Columbus, Ohio, 43210
- Recruiting
Horizon Clinical Research: Gill Neuroscience - Houston (Site #232)
Cypress, Texas, 77429
- Recruiting
Duke Neurological Disorders Clinic (Site #210)
Durham, North Carolina, 27705
- Recruiting
Rocky Mountain Clinical Research - CenExel - PPDS (Site #215)
Englewood, Colorado, 80113-2776
- Recruiting
Quest Research Institute - Alcanza - PPDS (Site #201)
Farmington Hills, Michigan, 48334-2973
- Recruiting
Velocity Clinical Research - Hallandale Beach (Site #228)
Hallandale, Florida, 33009
- Recruiting
Josephson Wallack Munshower Neurology PC (Site #231)
Indianapolis, Indiana, 46256
- Recruiting
The University of Kansas (KU) (Site #216)
Kansas City, Kansas, 66160
- Recruiting
EvergreenHealth (Site #219)
Kirkland, Washington, 98034-3013
- Recruiting
Kentucky Neuroscience Institute (Site #213)
Lexington, Kentucky, 40536-0001
- Recruiting
University of Arkansas for Medical Sciences (Site #208)
Little Rock, Arkansas, 72205-5551
- Recruiting
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217)
Los Alamitos, California, 90720-3108
- Recruiting
Keck Medicine of USC - USC Healthcare Center 2 (Site #221)
Los Angeles, California, 90033-5310
- Recruiting
University of Miami (Site #220)
Miami, Florida, 33136-1051
- Recruiting
Vanderbilt University Medical Center (Site #204)
Nashville, Tennessee, 37232
- Recruiting
Joan and Sanford I. Weill Department of Medicine (Site #224)
New York, New York, 10021
- Recruiting
Mount Sinai School of Medicine (Site #209)
New York, New York, 10029-6501
- Recruiting
Neurology One (Site #205)
Orlando, Florida, 32825
- Recruiting
Parkinson's Research Centers of America (Site #218)
Palo Alto, California, 94301
- Recruiting
Central Texas Neurology Consultants (Site #203)
Round Rock, Texas, 78681-3578
- Recruiting
USF Parkinson's Disease and Movement Disorders Center (Site #206)
Tampa, Florida, 33613-4808
About this study
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
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.
- Conditions
- Parkinson Disease
- Being tested
- AP-472, Placebo
- Keywords
- Parkinson's Disease, Parkinson Disease, Motor Fluctuations, OFF Time, Wearing-Off, Dyskinesia, AP-472, Adjunctive Therapy, Levodopa Adjunct, Positive Allosteric Modulator, Metabotropic Glutamate Receptor 4
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP-472Drug
Oral tablet
PlaceboOther
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | AP-472 100 mg per day Receives: Drug: AP-472; Other: Placebo |
| High Dose | Experimental | AP-472 300 mg per day Receives: Drug: AP-472 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in average daily OFF time on motor diaries for AP-472 compared to placebo (normalized to 16-hour awake time)
Measured: Week 12
Secondary outcomes (5)
Change from baseline in ON time without troublesome dyskinesia (normalized to 16 hours)
Measured: 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
For MDS-UPDRS Part II (Motor Experiences of Daily Living, M-EDL) there are 13 items each scored from 0 to 4. The total score range is from 0-52. A higher score indicates worse motor impact on daily activities; lower scores are better.
Measured: Week 12
Change from baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index
For the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index the score is calculated by averaging the 8 domain scores and converting them to a 0-100 scale. A higher score indicates worse health-related quality of life; lower scores are better.
Measured: Week 12
Change from baseline in MDS-UPDRS Part III (Motor Examination) score in the best ON state
The MDS-UPDRS Part III includes 33 items, each scored from 0 to 4. The total score range is from 0-132. A higher score indicates worse motor impairment; lower scores are better.
Measured: Week 12
Change from baseline in Epworth Sleepiness Scale (ESS) total score
The ESS consists of 8 items, each scored from 0 to 3. The total score range is from 0-24. Higher scores indicate greater daytime sleepiness; lower scores are better.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start25 Feb 2026
- Primary completion3 Sep 2027 (estimated)
- Study completion3 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Appello Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432958
- Sponsor's protocol ID
- APLO-1201
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07432958
- Acronym / sponsor ID
- APLO-1201
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Parkinson Disease, Motor Fluctuations, OFF Time, Wearing-Off, Dyskinesia, AP-472, Adjunctive Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Appello Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 3 Sep 2027 (estimated)
- Study completion
- 3 Jan 2028 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: AP-472, Other: PlaceboAP-472 100 mg per day |
| High Dose | Experimental | Drug: AP-472AP-472 300 mg per day |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP-472Oral tablet | Drug | High Dose, Low Dose |
| PlaceboOral tablet | Other | Low Dose, Placebo |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP-472 in people with Parkinson Disease, run by Appello Pharmaceuticals, Inc. at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annie Blobaum, Ph.D. (615-427-1935, annie@appellopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.