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
๐ฉบ Protocol 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 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.
Primary Research Facility: University of Arkansas for Medical Sciences (Site #208) (Little Rock, Arkansas)
๐ Basic Study Criteria & Logistics Checklist
0 of 3 CheckedReview these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).
๐ Primary Site Map
Site: University of Arkansas for Medical Sciences (Site #208) โ Little Rock, Arkansas
๐ All Participating Trial Locations (30 Sites)
Multi-Center TrialThis protocol is enrolling participants across multiple clinical centers:
๐ Print Doctor Discussion Sheet
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๐ฐ Clinical Trial Costs & Insurance Coverage
Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.
๐ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.