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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Appello Pharmaceuticals, Inc.
Study ID
NCT07432958
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AP-472 — DRUG
    Oral tablet
  • Placebo — OTHER
    Oral tablet

Study Details

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.

Key Dates

Start date
Feb 25, 2026
Status verified
Apr 2026
Primary completion
Sep 3, 2027
Completion
Jan 3, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose
    AP-472 100 mg per day
  • Experimental: High Dose
    AP-472 300 mg per day
  • Placebo Comparator: Placebo

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 ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-5551-
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDSLos AlamitosCalifornia90720-3108-
Keck Medicine of USC - USC Healthcare Center 2Los AngelesCalifornia90033-5310-
North County Neurology AssociatesOceansideCalifornia92056-4454-
Parkinson's Research Centers of AmericaPalo AltoCalifornia94301-
Rocky Mountain Clinical Research - CenExel - PPDSEnglewoodColorado80113-2776-
University of MiamiMiamiFlorida33136-1051-
Neurology OneOrlandoFlorida32825-
USF Parkinson's Disease and Movement Disorders CenterTampaFlorida33613-4808-
Augusta University Medical CenterAugustaGeorgia30912-0020-
The University of Kansas (KU)Kansas CityKansas66103-2078-
Kentucky Neuroscience InstituteLexingtonKentucky40536-0001-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-5400-
University of Michigan Health System (UMHS)Ann ArborMichigan48109-
Quest Research Institute - Alcanza - PPDSFarmington HillsMichigan48334-2973-
University of New Mexico Health Sciences CenterAlbuquerqueNew Mexico87131-0001-
Joan and Sanford I. Weill Department of MedicineNew YorkNew York10065-
Mount Sinai School of MedicineNew YorkNew York10029-6501-
Duke Neurological Disorders ClinicDurhamNorth Carolina27705-
Cleveland ClinicClevelandOhio44195-0001-
The Ohio State University Wexner Medical CenterColumbusOhio43202-4500-
Movement Disorder Clinic of Oklahoma PLLCTulsaOklahoma74136-7027-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Central Texas Neurology ConsultantsRound RockTexas78681-3578-
EvergreenHealthKirklandWashington98034-3013-

Find similar trials in Little Rock, AR

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Arkansas for Medical Sciences· Little Rock, ARCollaborative Neuroscience Network - Los Alamitos- CenExel - PPDS· Los Alamitos, CAKeck Medicine of USC - USC Healthcare Center 2· Los Angeles, CANorth County Neurology Associates· Oceanside, CAParkinson's Research Centers of America· Palo Alto, CARocky Mountain Clinical Research - CenExel - PPDS· Englewood, CO

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