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Study on the Effectiveness of BP1.4979 for Adults with Essential Tremor

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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 Essential Tremor, a condition that causes involuntary shaking, often in the hands. The trial will evaluate a new treatment called BP1.4979, which is taken as a tablet. The purpose of the study is to assess how effective and safe this treatment is for adults with essential tremor.

Participants in the study will be randomly assigned to receive either the BP1.4979 tablet or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The trial will last for a period of 32 weeks, during which participants will take the medication and attend regular check-ups to monitor their progress and any side effects.

The main goal is to see if there is a change in the severity of the tremors after four weeks of treatment, using a specific scale called the Essential Tremor Rating Assessment Scale. This scale helps measure the impact of the tremor on daily activities. The study does not plan to measure any other outcomes beyond this primary goal. Participants will be closely monitored throughout the trial to ensure their safety and well-being.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive the test medication, BP1.4979, and the other group will receive a placebo, which is a tablet that looks like the medication but does not contain the active substance.

    The trial is double-blind, meaning neither you nor the researchers will know which group you are in. This helps ensure the results are unbiased.

  2. Step 2

    Medication administration

    If you are in the group receiving BP1.4979, you will take the medication orally in the form of a tablet. The dosage and frequency will be determined by the trial protocol, and you will be informed of these details at the start of the trial.

    The duration of the medication administration is four weeks. It is important to take the medication exactly as instructed and not to change the dosage or frequency on your own.

  3. Step 3

    Regular assessments

    Throughout the trial, you will undergo regular assessments to monitor the effects of the medication. These assessments will include evaluating the severity of your tremors using a scale called the Essential Tremor Rating Assessment Scale (TETRAS-P).

    The primary focus is on the change in your tremor severity after four weeks of treatment. This will help determine the effectiveness of the medication.

  4. Step 4

    Completion of the trial

    At the end of the four-week period, you will complete the trial. Final assessments will be conducted to gather data on the medication's efficacy and safety.

    You will be informed about the next steps and any follow-up procedures that may be necessary.

Who can join the trial?

10 criteria

  • Provide written informed consent before any trial-related procedures. This means you agree to participate after being informed about the study.
  • If you are a female participant, you must either be a post-menopausal woman (no menstrual periods for at least 12 months without other medical reasons) or, if you can still have children, use a highly effective method of birth control during the trial and for one month after stopping the trial medication.
  • You must be between 18 and 85 years old.
  • Have a confirmed diagnosis of Essential Tremor (ET), which includes having a tremor in both arms for at least three years. The tremor might also be present in other areas like the voice or legs.
  • Your ET must be characterized by a TETRAS-P score of at least 1.5 in specific movements of the arms. This score is part of a scale used to assess the severity of tremors.
  • If you are taking medication for tremors, you must have been on the same dose for at least four weeks before the study starts and be willing to keep the same dose during the study.
  • You should not have had any surgery specifically for treating tremors.
  • There should be at least four months since your last botulinum injection before starting the study.
  • You should not have significant balance problems due to tremors or be at a high risk of falling.
  • You must be willing to follow all trial requirements and procedures, such as completing questionnaires and taking the trial medication as instructed.

Who cannot join the trial?

10 criteria

  • Patients with any other significant medical condition that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
  • Patients with known allergies to the study medication or its ingredients.
  • Patients with severe liver or kidney disease.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of certain mental health disorders.
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Investigated drugs

BP1.4979 is a medication being tested to see if it can help people with essential tremor, which is a condition that causes shaking you can't control. The trial is designed to find out if this medication can reduce the shaking and improve the quality of life for those affected. The study is also looking at how safe the medication is for patients to use. Participants in the trial will take this medication, and researchers will monitor them to see how well it works and if there are any side effects.

What is already known about the treatment

BP1.4979 – BP1.4979 is administered orally in the form of a tablet, making it easy for patients to take. It is currently being studied in clinical trials to determine its effectiveness and safety for treating essential tremor, a condition that causes involuntary shaking. The medication works by targeting specific pathways in the brain that are involved in the control of movement, helping to reduce the symptoms of tremor. BP1.4979 is classified as a neurological agent, focusing on improving the quality of life for individuals with essential tremor.

Investigated diseases

Essential tremor – Essential tremor is a neurological disorder characterized by involuntary and rhythmic shaking, most commonly affecting the hands. It can also impact the head, voice, and other parts of the body. The tremor typically occurs during voluntary movements, such as eating or writing, and is less noticeable at rest. The condition often begins gradually and may worsen over time. It is distinct from Parkinson's disease, although it can sometimes be confused with it. The exact cause of essential tremor is not fully understood, but it is believed to involve genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517987-46-00Protocol codeP23-05Estimated enrolment50 patientsSponsorBioprojet Pharma

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