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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Policlinica Gipuzkoa S.A.	Donostia / San Sebastian	Spain
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Hewfmlua Vznj dxuvxsyt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	16.09.2024
Spain	Not recruiting	16.09.2024

Trial locations

Investigated drugs:

Exidavnemab

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.

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 ID:

2024-511222-30-00

Protocol code:

BAN0805-201

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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