AP-472 for Parkinson's Disease with Motor Fluctuations
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
Recruiting
Phase 2Interventional Study
Parkinson Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
30 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Appello Pharmaceuticals, Inc. · Industry
Who this trial is looking for
This trial is looking for people with Parkinson's disease who have motor fluctuations while taking their medication. Participants will receive either the study drug AP-472 or a placebo for about 12 weeks to see how well it works.
Are You a Good Fit for This Trial?
Must be takingLevodopa
You may be able to join if
I am between 30 and 80 years old.
I have been diagnosed with Parkinson's disease.
I experience at least 3 hours of OFF time each day.
I have a MoCA score of 24 or higher.
I can walk on my own or with a walking aid.
I can swallow oral medication.
I have been on a stable Parkinson's medication regimen for at least 4 weeks.
I take levodopa at least three times daily.
You may not be able to join if
I have a different type of parkinsonism.
I have received advanced therapies for Parkinson's in the past.
I have severe involuntary movements affecting my participation.
I take medications that block dopamine.
I use on-demand rescue Parkinson's medications more than three times a week.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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. Neithe…
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.
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Eligibility Criteria
Key Inclusion Criteria:
Participants must meet all of the following criteria to take part in the study:
1. Be a man or woman between 30 and 80 years of age at the time of screening.
2. Have a diagnosis of Parkinson's disease, confirmed using standard medical criteria, including slowness of movemen…
Key Inclusion Criteria:
Participants must meet all of the following criteria to take part in the study:
1. Be a man or woman between 30 and 80 years of age at the time of screening.
2. 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.
3. 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).
4. 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.
5. Have a Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening.
6. Be able to walk independently, with or without the use of a walking aid.
7. Be able to swallow oral medication.
8. Have been on a stable Parkinson's medication regimen for at least 4 weeks before screening. Medications known as MAO-B inhibitors must have been stable for at least 12 weeks.
9. Be taking levodopa at least four times daily (immediate- or controlled-release formulations) or three times daily (extended-release formulations such as Rytary or Crexont).
Key Exclusion Criteria:
Participants cannot take part in the study if any of the following apply:
1. Have a form of parkinsonism that is not typical Parkinson's disease, such as secondary or atypical parkinsonism.
2. 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.
3. Have dyskinesias (involuntary movements) that are severe enough, in the study doctor's opinion, to interfere with participation.
4. Have a history of only certain types of dyskinesias (such as OFF-state, diphasic, myoclonic, or dystonic dyskinesias) without typical peak-dose dyskinesias.
5. Are currently taking medications that block dopamine, except for low-dose quetiapine (up to 50 mg per day) used for insomnia.
6. Routinely use on-demand "rescue" Parkinson's medications more than three times per week.
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