IRB Study Number 26-776
Status Recruiting
Phase Phase 2
Location Cleveland Clinic Main Campus
Institute Neurological Institute
Description
This is a phase 2 study in people with PD 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 20 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.
Inclusion Criteria
- Age 30-80 years
- Diagnosis of PD, including slowness of movement and symptoms that affect one side of the body more than the other
- Have mild to moderate PD, defined as stage 3 or lower on the Hoehn and Yahr scale when medications are working ("ON" state)
- Experience average of at least 3 hours of OFF time per day, based on home symptom diaries, with at least 2.5 hours OFF time each day during baseline period
- Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening
- Able to walk independently, with or without use of walking aid
- Able to swallow oral medication
- On stable Parkinson's medication regimen for at least 4 weeks before screening. Medications known as MAO-B inhibitors must have been stable at least 12 weeks
- Taking levodopa at least four times daily (immediate- or controlled-release formulations) or three times daily (extended-release formulations such as Rytary or Crexont)
Exclusion Criteria
- Have 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 study doctor's opinion, to interfere with participation
- Have history of only certain types of dyskinesias (such as OFF-state, diphasic, monoclonic, or dystonic dyskinesias) without typical peak-dose dyskinesias
- 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 3 times per week
*Additional criteria as listed in the protocol
