150 Participants NeededMy employer runs this trial

AP-472 for Parkinson's Disease

Recruiting at 24 trial locations
AB
Overseen ByAnnie Blobaum, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Appello Pharmaceuticals, Inc.
Must be taking: Levodopa
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I take levodopa at least four times daily or three times if it's extended-release.
Have a Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening
I can walk on my own, with or without a walking aid.
See 6 more

Exclusion Criteria

I have had or will have advanced Parkinson's treatments.
Have dyskinesias that are severe enough to interfere with participation
Have a history of certain types of dyskinesias without typical peak-dose dyskinesias
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stabilization

Parkinson's medications must remain stable

4 weeks

Treatment

Participants receive one of two doses of AP-472 or placebo

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AP-472

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Low DoseExperimental Treatment2 Interventions
Group II: High DoseExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Appello Pharmaceuticals, Inc.

Lead Sponsor