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.
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 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.
Parallel
AP-472
DrugOral tablet
Placebo
Other interventionOral tablet
Change from Baseline in average daily OFF time on motor diaries for AP-472 compared to placebo (normalized to 16-hour awake time)
Change from baseline in ON time without troublesome dyskinesia (normalized to 16 hours)
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.
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.
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.
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