Phase 2 Parkinson's Disease Trial, Recruiting NCT05824728 Sponsor: Johns Hopkins University Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Recruiting

NCT05824728
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:

  • You are between 40 and 85 years old and are generally in good health.
  • You are willing and able to give your consent and take part for the full length of the study.
  • You completed at least an eighth-grade education, or have a solid work history (confirm with trial site).
  • You can see and hear well enough to complete thinking and memory tests (glasses and hearing aids are fine if you use them).
  • You speak the local language fluently enough to take part in all assessments.
  • You have someone in your life (a partner, family member, or friend) who spends at least 2 hours per week with you and can help with medication and report on how you are doing.
  • You have been diagnosed with Parkinson's disease AND are experiencing at least one of the following: seeing things that are not there (hallucinations), sensing a presence that is not there, mistaking one thing for another (illusions), or having strong false beliefs (delusions).
  • These symptoms started after your Parkinson's disease diagnosis and have been happening regularly for at least 1 month.
  • These symptoms are not better explained by another condition such as schizophrenia or another form of dementia (confirm with trial site).
  • You have been experiencing these symptoms at least once a week during the 4 weeks before your screening appointment.
  • If you are currently taking medication specifically for these symptoms (hallucinations/delusions), you must have stopped taking it at least 2 weeks before the study begins.
  • Your Parkinson's disease medications have stayed the same for at least 4 weeks before the study begins.
  • If you take certain memory-support medications, antidepressants, or antipsychotics, they must have been at a stable dose for at least 1 month before screening and are expected to stay the same throughout the study.
  • You are willing and able to have repeated MRI brain scans (3 Tesla) with no reasons why an MRI would be unsafe for you.
  • You and your partner are both willing to use effective contraception during the study and for 4 days after it ends (hormonal methods for women; condoms for men).

Who may not be able to join:

  • You have taken anti-seizure (anticonvulsant) medications within the past month.
  • You have taken part in another clinical treatment trial within the past month, or plan to join another trial while this one is ongoing.
  • You have previously had a bad reaction to, or could not tolerate, the study drug AGB101 (also known as levetiracetam).
  • You have serious kidney problems or are currently on kidney dialysis.
  • You are currently experiencing confusion or delirium caused by an infection or other acute medical condition.
  • You have another brain or neurological condition besides Parkinson's disease (such as Alzheimer's disease, Huntington's disease, multiple sclerosis, a history of seizures, or significant brain injury with lasting effects) that might interfere with the study.
  • You have previously been diagnosed with schizophrenia, bipolar disorder, or another psychotic disorder unrelated to Parkinson's disease.
  • You have had deep brain stimulation (DBS) surgery, or have a pacemaker, aneurysm clips, artificial heart valves, ear implants, or any metal fragments or implants in your body that would make an MRI unsafe.
  • You have had a problem with alcohol or drug misuse or dependence in the past 3 years.
  • You have a serious or unstable physical illness that could make it hard to follow the study's requirements.
  • You have an unstable health condition likely to need new medical or surgical treatment during the study that could affect the results.
  • You are unable or unwilling to give informed consent or follow the study procedures.
  • You or your caregiver are unable to give the daily oral study medication.
  • You are currently having thoughts of suicide.
  • You are pregnant or breastfeeding (for female participants).
  • There is any other reason the study doctor believes you should not take part (confirm with trial site).

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 16 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

Principal Investigator: Arnold Bakker, Ph.D., Johns Hopkins University

Phone: 410-955-5057

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
Registry
ClinicalTrials.gov
Start date
28 September 2023
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in hallucinations/delusions as assessed by the Enhanced Scale for Assessment of Positive Symptoms in Parkinson's Disease (eSAPS-PD)

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: 16 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