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Study on the Safety and Tolerability of Exidavnemab in Patients with Mild to Moderate Parkinson's Disease

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Parkinson's Disease, a condition that affects movement and can cause symptoms like tremors, stiffness, and difficulty with balance and coordination. The trial will test a new treatment called Exidavnemab, which is a type of medication known as a monoclonal antibody. This medication is given as a solution through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and tolerability of Exidavnemab in patients with mild to moderate Parkinson's Disease who are already on stable medication for their symptoms. Participants in the study will receive either the new treatment or a placebo, which is a substance with no active medication. The study will involve multiple doses of the treatment over a period of time to observe any potential side effects and how well the treatment is tolerated by the participants.

Throughout the study, participants will be monitored for any changes in their health, including vital signs like blood pressure and heart rate, as well as laboratory tests. The study aims to gather information on the best dose of Exidavnemab and how it behaves in the body. This research is important for understanding if Exidavnemab could be a safe and effective treatment option for people living with Parkinson's Disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current medications.

    A physical examination and laboratory tests are performed to ensure health status aligns with study requirements.

  2. Step 2

    Baseline visit

    A baseline visit is scheduled to establish initial health metrics. This includes a pregnancy test for applicable participants and confirmation of stable Parkinson's medication.

    Participants are required to sign an informed consent form before any trial-specific procedures are performed.

  3. Step 3

    Treatment phase

    Participants receive either exidavnemab or a placebo through an intravenous infusion. The solution is administered in multiple doses over the course of the study.

    The frequency and dosage of exidavnemab are determined by the study protocol, focusing on safety and tolerability.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the occurrence of any adverse effects. This includes checking vital signs, conducting ECGs, and performing laboratory tests.

    Participants are required to attend scheduled visits for ongoing evaluation of their health and response to the treatment.

  5. Step 5

    Final assessment

    At the end of the treatment cycles, a final assessment is conducted to evaluate the overall safety and tolerability of the treatment.

    The study concludes with a review of all collected data to determine the effects of exidavnemab on Parkinson's disease symptoms.

Who can join the trial?

14 criteria

  • Participants must be men or women aged between 40 and 85 years.
  • Women who can have children must have a negative pregnancy test before starting the trial.
  • Men and women who can have children must agree to use effective birth control during the trial and for 3 months after their last dose of the trial medication.
  • Participants must be willing and able to attend scheduled visits, follow the treatment plan, and complete laboratory tests and trial procedures.
  • Participants must understand their daily medication routine and agree not to change their medication doses during the trial.
  • Participants must be able to give informed consent, meaning they understand the trial and agree to participate by signing a consent form.
  • Participants must weigh between 50 kg (about 110 pounds) and 120 kg (about 265 pounds).
  • Participants must have **Idiopathic Parkinson's Disease**, which means Parkinson's not caused by drugs or other diseases, and show symptoms like slow movement (bradykinesia) along with either resting tremor or stiffness (rigidity).
  • Participants must be classified as Stage 1 to 2.5 on the **Hoehn and Yahr scale**, which measures the severity of Parkinson's Disease.
  • Participants must not have dementia, confirmed by a score of 22 or higher on the **MoCA**, a test that checks thinking abilities.
  • Participants must have stable Parkinson's medication, meaning they have been taking the same medications for at least 3 months before the trial and have not changed the dose for at least 1 month before starting the trial.
  • Participants must have a past or current **DaT-SPECT** or **DaT-PET** scan showing a dopamine transporter deficit, which is a sign of Parkinson's Disease. If they haven't had this scan before, they must have it done as part of the trial screening.
  • Participants must have a positive smell test showing **hyposmia**, which means a reduced ability to smell, as determined by a specific test score.
  • Participants must be able to use a tablet device to measure cognitive function, as judged by the trial investigator.

Who cannot join the trial?

9 criteria

  • Patients who have a history of severe allergic reactions to any of the ingredients in the study medication.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a serious medical condition that might interfere with the study, such as uncontrolled high blood pressure or heart disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who have had a major surgery within the last month.
  • Patients who have a known infection with HIV, hepatitis B, or hepatitis C.
  • Patients who have a mental health condition that might affect their ability to participate in the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

Exidavnemab is an investigational medication being studied for its potential effects on patients with mild to moderate Parkinson's Disease. The trial aims to evaluate how safe and tolerable this medication is when given in multiple doses. Participants in the study are already on stable medications for their Parkinson's symptoms, and this trial will help determine if adding exidavnemab can be done safely.

What is already known about the treatment

Exidavnemab – Exidavnemab is administered through injections and is currently being studied in clinical trials for its safety and tolerability in patients with mild to moderate Parkinson's Disease. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for exidavnemab is Parkinson's Disease, where it aims to help manage symptoms. At the molecular level, exidavnemab works by targeting specific proteins involved in the disease process, potentially altering their activity to provide therapeutic benefits. It is classified pharmacologically as a monoclonal antibody, which is a type of protein designed to interact with specific targets in the body.

Investigated diseases

Parkinson's Disease – Parkinson's Disease is a progressive neurological disorder that primarily affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. As the disease progresses, individuals may experience slowness of movement and a decrease in facial expressions. The condition is caused by the degeneration of nerve cells in the brain that produce dopamine, a chemical that helps control movement. Over time, symptoms can become more pronounced, affecting daily activities and quality of life. Non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment may also occur.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511222-30-00Protocol codeBAN0805-201Estimated enrolment36 patientsSponsorBioArctic AB

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).