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Study on the Effectiveness and Safety of BIIB122 for Patients with Parkinson's Disease

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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 is testing a new treatment called BIIB122, which is a tablet taken orally. The purpose of the study is to evaluate how effective and safe BIIB122 is compared to a placebo, which looks like the real medication but does not contain any active ingredients.

Participants in the study will be randomly assigned to receive either BIIB122 or the placebo. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will take place over a period of time, during which participants will be monitored for any changes in their symptoms and any side effects they might experience.

The main goal is to see if BIIB122 can slow down the worsening of symptoms associated with Parkinson's Disease. Researchers will use a specific scale called the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) to measure changes in symptoms. They will also track any adverse events or serious adverse events that occur during the study. The study aims to provide valuable information about the potential benefits and risks of BIIB122 for people living with Parkinson's Disease.

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

    Randomization and initial assessment

    Upon joining the study, participants are randomly assigned to receive either the BIIB122 medication or a matching placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

    An initial assessment is conducted to establish baseline measurements. This includes evaluating the participant's condition using the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and other relevant scales.

  2. Step 2

    Medication administration

    Participants take the assigned medication orally in the form of a tablet. The dosage for BIIB122 is 225 mg.

    The medication is taken according to the study's schedule, which is determined by the research team. The duration of administration is throughout the treatment period specified in the study protocol.

  3. Step 3

    Ongoing assessments

    Regular assessments are conducted to monitor the participant's condition and any changes in symptoms. These assessments include repeated evaluations using the MDS-UPDRS and other scales.

    The study aims to track the time to confirmed worsening in the MDS-UPDRS Parts II and III combined score, as well as other secondary endpoints such as the incidence of adverse events.

  4. Step 4

    Completion of treatment period

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

    Participants' data is analyzed to determine the impact of BIIB122 compared to the placebo, focusing on the primary and secondary endpoints outlined in the study.

Who can join the trial?

5 criteria

  • You must have a clinical diagnosis of **Parkinson's Disease** that meets specific criteria within 2 years of the screening visit. You should have been at least 30 years old when diagnosed.
  • Your condition should be at stages 1 to 2 on the **Modified Hoehn and Yahr scale** when not taking medication. This scale measures the severity of Parkinson's Disease.
  • Your combined score on parts II and III of the **MDS-UPDRS** (a scale used to measure Parkinson's symptoms) should be 40 or less when not taking medication.
  • A genetic test must show that you do not have certain specific changes (called **variants**) in a gene known as **LRRK2**. These changes are linked to Parkinson's Disease. The test must be done by a recognized lab and include all the specific variants that would exclude you from the study.
  • Other criteria defined in the study protocol may also apply.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than Parkinson's Disease cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet other specific criteria set by the study, which are not listed here, cannot participate.
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Investigated drugs

BIIB122 is a medication being studied for its effectiveness and safety in treating Parkinson's Disease. The trial aims to determine how well this medication works in managing the symptoms of the disease compared to a placebo.

What is already known about the treatment

BIIB122 – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating Parkinson's Disease. The main therapeutic indication is to alleviate symptoms associated with Parkinson's Disease. BIIB122 works by targeting specific pathways in the brain that are involved in the progression of Parkinson's Disease, aiming to slow down or modify the disease process. It is classified as a neuroprotective agent, focusing on protecting nerve cells from damage.

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 a barely noticeable tremor in just one hand. As it advances, individuals may experience slowness of movement, muscle rigidity, and impaired posture. Non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment can also occur. The exact cause of Parkinson's Disease is unknown, but it involves the loss of nerve cells in the brain that produce dopamine.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505645-12-00Protocol code283PD201Estimated enrolment640 patientsSponsorBiogen Idec Research Limited

sourced from the EU Clinical Trials Register and site verification

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