Phase 2 Parkinson's Disease Trial, Recruiting NCT07432958 Sponsor: Appello Pharmaceuticals, Inc. Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Recruiting

NCT07432958
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People between 30 and 80 years of age at the time of screening.
  • People who have been diagnosed with 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.
  • People with mild to moderate Parkinson's disease, rated at stage 3 or lower on a standard Parkinson's scale (Hoehn and Yahr) during periods when their medication is working well.
  • People who experience an average of at least 3 hours per day of "OFF" time (periods when Parkinson's symptoms are not well controlled), based on home symptom diaries, with at least 2.5 hours of OFF time each day during the lead-up period before the trial begins.
  • People who score 24 or higher on a standard memory and thinking assessment called the Montreal Cognitive Assessment (MoCA) at screening.
  • People who are able to walk independently, with or without a walking aid.
  • People who are able to swallow tablets or capsules.
  • People whose Parkinson's medications have remained unchanged for at least 4 weeks before screening — or at least 12 weeks for a specific type of medication called MAO-B inhibitors.
  • People who are taking levodopa at least four times daily (in standard or controlled-release forms), or at least three times daily if using an extended-release formulation such as Rytary or Crexont.

Who may not be able to join:

  • People whose condition is a form of parkinsonism other than typical Parkinson's disease, such as secondary or atypical parkinsonism.
  • People who have previously received, or who are expected to receive during the trial, advanced Parkinson's treatments such as continuous medication delivery systems or Parkinson's-related brain surgery.
  • People who experience involuntary movements (dyskinesias) severe enough that, in the study doctor's opinion, these would interfere with taking part in the trial.
  • People whose involuntary movements are only of certain specific types (such as those occurring in the OFF state, diphasic, myoclonic, or dystonic dyskinesias), without the more typical peak-dose type of involuntary movements.
  • People who are currently taking medications that block dopamine, with the exception of low-dose quetiapine (up to 50 mg per day) taken for sleep problems.
  • People who regularly use on-demand "rescue" Parkinson's medications more than three times per week.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 615-427-1935

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Appello Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
25 February 2026
Est. completion
3 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from Baseline in average daily OFF time on motor diaries for AP-472 compared to placebo (normalized to 16-hour awake time)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov