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

Conditions

• Parkinson Disease

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

First listed

Feb 25, 2026

Start date

Feb 25, 2026

Status verified

Jul 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

• Annie Blobaum, Ph.D.
  615-427-1935
  [email protected]

Locations (30)

Find similar trials in Little Rock, AR

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