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Study on BIA 28-6156 for Parkinson's Disease in Patients with GBA1 Gene Variant

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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 tremors, stiffness, and difficulty with balance and coordination. The study is investigating a new treatment called BIA 28-6156, which is an allosteric activator of the enzyme beta-glucocerebrosidase (GCase). This enzyme is important for breaking down certain substances in the body, and the treatment aims to help manage symptoms in people with Parkinson's Disease who have a specific genetic variant in the GBA1 gene.

The purpose of the study is to evaluate how effective BIA 28-6156 is in slowing down the progression of motor symptoms in individuals with this genetic variant. Participants in the study will be randomly assigned to receive either the treatment or a placebo, which looks like the treatment but does not contain the active substance. The study will be conducted over a period of time, during which participants will take the medication in the form of a film-coated tablet by mouth. The study will monitor the safety and tolerability of the treatment, as well as how it is processed by the body.

Throughout the study, participants will be assessed using a scale called the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS), which helps measure the severity of motor symptoms. The study aims to determine if BIA 28-6156 can delay the worsening of these symptoms compared to the placebo. This research is important for understanding potential new treatments for Parkinson's Disease, especially for those with the GBA1 gene variant.

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 study

    Upon joining the study, you will be randomly assigned to receive either the investigational medication BIA 28-6156 or a placebo. A placebo is a substance with no active medication, used to compare the effects of the investigational drug.

  2. Step 2

    Medication administration

    If you are assigned to the BIA 28-6156 group, you will take the medication in the form of a film-coated tablet. The medication is taken orally, meaning you will swallow the tablet with water.

    The dosage, frequency, and duration of administration will be provided by the study team. It is important to follow the instructions carefully to ensure the accuracy of the study results.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your health and the effects of the medication will be closely monitored. This includes regular assessments of your motor skills and daily living activities using a scale called the Movement Disorder Society - Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).

    You will be required to use a smartphone application and wear a smartwatch to measure Parkinson’s disease-related motor signs. This helps in tracking your progress and any changes in your condition.

  4. Step 4

    Completion of the study

    The study is expected to continue until June 2026. Upon completion, you will have a final assessment to evaluate the overall effects of the medication.

    Your participation will contribute to understanding the efficacy and safety of BIA 28-6156 in treating Parkinson’s disease with a specific genetic variant.

Who can join the trial?

13 criteria

  • The person is between 35 and 80 years old.
  • The person has been diagnosed with Parkinson's Disease for at least 1 year but not more than 7 years.
  • The person has a GBA1 gene variant linked to Parkinson's Disease, as determined by genetic screening in the study.
  • The person is receiving treatment to help with Parkinson's Disease symptoms.
  • The person can understand and sign a consent form, which explains the study's purpose, risks, and requirements.
  • The person has a score of 2.5 or less on the Hoehn and Yahr scale, which measures the severity of Parkinson's Disease.
  • The person has a score of 22 or higher on the MoCA scale, a test that checks thinking and memory skills.
  • The person does not have moderate motor complications, as shown by a score of less than 3 on certain parts of the MDS-UPDRS Part IV, a scale that measures movement issues.
  • The person does not have significant psychosis, which means they do not have severe mental health issues like hallucinations or delusions.
  • The person has been on stable doses of Parkinson's Disease medications for at least 30 days (or 60 days for a medication called rasagiline) before starting the study.
  • The person is willing and able to use a smartphone app and wear a smartwatch to track Parkinson's Disease-related movement signs during the study.
  • The person has a Body Mass Index (BMI) between 18 and 40. BMI is a measure of body fat based on height and weight.
  • If the person is sexually active and can have children, they agree to use highly effective birth control methods or remain abstinent during the study and for 30 days after the last dose of the study medication.

Who cannot join the trial?

4 criteria

  • Patients who do not have a confirmed diagnosis of Parkinson's Disease with a specific genetic variant in the GBA1 gene cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

BIA 28-6156 is a medication being studied for its potential to help people with Parkinson's disease, specifically those who have a certain genetic variant known as GBA1. This medication is being tested to see if it can slow down the worsening of movement problems that are common in Parkinson's disease. The study aims to find out if BIA 28-6156 can make a difference in how quickly these movement issues progress, which could improve the quality of life for people with this condition. The medication is being evaluated for its effectiveness, safety, and how well people can tolerate it.

What is already known about the treatment

BIA 28-6156 – BIA 28-6156 is administered orally and is currently being studied in clinical trials for its potential use in treating Parkinson's Disease, specifically in patients with a genetic variant in the GBA1 gene. This medication is in the experimental phase and is not yet widely recognized in medical literature as a standard treatment. It is being investigated for its ability to slow down the progression of motor symptoms in Parkinson's Disease. At the molecular level, BIA 28-6156 is believed to work by influencing pathways related to the glucocerebrosidase enzyme, which is linked to the disease's progression. It falls under the pharmacological classification of investigational drugs for neurodegenerative disorders.

Investigated diseases

Parkinson's Disease – Parkinson's Disease is a progressive neurological disorder that affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. The disease progresses gradually, often starting with barely noticeable tremors in one hand. As it advances, individuals may experience slowness of movement, muscle rigidity, and impaired posture. Over time, the symptoms can become more severe, affecting daily activities and leading to difficulties in walking and talking. The progression of Parkinson's Disease varies among individuals, with some experiencing a slow progression and others a more rapid decline in motor function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501783-18-00Protocol codeBIA 28-6156-201Estimated enrolment252 patientsSponsorBial R&D Investments S.A.

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