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A Phase II Randomized, Double‑Blind Study of RO7568282 for Safety and Efficacy in Early‑Stage Parkinson’s Disease Patients

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What is this trial about?

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

The study investigates early‑stage Parkinson’s Disease, a brain disorder that causes shaking, stiffness, and slow movement. The experimental medication being tested is called RO7568282, taken as a hard capsule by mouth. The purpose of the study is to evaluate the effectiveness and safety of the drug compared with a placebo.

Participants will be randomly assigned to receive either the study drug or a placebo, and neither the participants nor the study staff will know which one is given (double‑blind). Over about two years, volunteers will attend regular clinic visits where doctors will check their movement abilities, especially when they are not taking their regular Parkinson’s medicines (the “off medication” state). Movement will be scored using a standard questionnaire called the MDS‑UPDRS Part III, which rates tremor, stiffness and speed of movement. Blood samples will be taken to see how the drug is absorbed and cleared from the body (pharmacokinetics). Safety checks will include heart rhythm testing (an ECG), blood and urine labs, and a questionnaire that measures thoughts of self‑harm called the C‑SSRS. Any side effects or health changes will be recorded throughout the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Baseline Assessment

    After you agree to join the study, you will be randomly assigned to receive either the investigational drug ro7568282 or a matching placebo. This assignment is done by a computer so that neither you nor the study staff knows which one you receive.

    At the same visit, doctors will record your current motor symptoms, overall health, and other measurements that will be used as a reference for later comparisons.

  2. Step 2

    Receive Study Medication

    You will be given a supply of oral capsules that look identical regardless of whether they contain ro7568282 or placebo. The capsules are hard‑filled and are taken by mouth.

    The label will include instructions on how many capsules to take each day, but the exact dose amount is not disclosed to you to keep the study blind.

  3. Step 3

    Start Taking Medication Daily

    You will begin taking one capsule each day as directed, continuing this routine for the entire treatment period.

    The medication (or placebo) will be taken at the same time each day, preferably with a glass of water.

  4. Step 4

    Attend Scheduled Study Visits

    Throughout the study, you will attend regular visits to the clinic. During each visit, study staff will check your motor function, record any side effects, and collect blood or urine samples as needed.

    These visits are usually spaced several weeks apart and continue until the end of the 104‑week treatment phase.

  5. Step 5

    Report Any Side Effects or Health Changes

    If you notice any new symptoms, discomfort, or changes in your health, you should inform the study team promptly, either during a scheduled visit or by contacting the study staff as instructed.

    All reported events will be evaluated for seriousness and possible relation to the study medication.

  6. Step 6

    Final Assessment at Week 104

    At the end of week 104, you will undergo a comprehensive evaluation of motor signs using the standard Parkinson’s disease rating scale while you are off any regular Parkinson’s medication.

    Blood samples will be taken to measure the concentration of ro7568282 and its metabolites, and additional safety tests will be performed.

  7. Step 7

    End of Study Treatment

    After the final assessment, you will stop taking the study capsules. The study team will discuss any remaining follow‑up needed for your health.

    Your participation data will be used to compare the effectiveness and safety of ro7568282 with placebo.

Who can join the trial?

6 criteria

  • You have been diagnosed with idiopathic Parkinson’s disease, which means Parkinson’s disease that is not caused by another known condition.
  • You have been taking only one Parkinson’s medicine (levodopa) at stable doses for at least two months before the study starts.
  • Your score on the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS‑UPDRS) Part IV must be 0, meaning you have no motor complications, when screened and before randomization.
  • Your disease stage measured by the Hoehn and Yahr (H&Y) scale must be 3 or lower while you are in an off medication state, both at screening and before randomization.
  • You must be able to swallow whole capsules.
  • You must be between 40 and 85 years old (inclusive) when you sign the Informed Consent Form.

Who cannot join the trial?

6 criteria

  • Having a Parkinson‑like condition that is not the typical form called idiopathic Parkinson’s disease (idiopathic means the cause is unknown).
  • Having Parkinson’s disease dementia, which is a decline in thinking and memory caused by Parkinson’s disease.
  • Having another serious brain or nerve disorder that is not Parkinson’s disease.
  • Having heart or blood‑vessel problems that are unstable or serious within the past year (for example, recent heart attacks or severe heart failure).
  • Having high blood pressure that is not controlled with medication (called chronic uncontrolled hypertension).
  • Having a brain scan (MRI) that shows abnormal structures not related to Parkinson’s disease.
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Investigated drugs

RO7568282 is an experimental oral capsule that is being tested to see if it can help people with early-stage Parkinson’s disease. In this study, participants take the capsule by mouth, and researchers will look at how well it works to improve symptoms, how safe it is, and how the body processes the medication. The goal is to determine whether this new treatment could become a useful option for managing Parkinson’s disease.

What is already known about the treatment

  • RO7568282

    This is an oral hard‑capsule taken by mouth, designed to dissolve in the stomach. It is an experimental drug that is still being studied in clinical trials and has not yet been approved for regular medical use. The main aim is to help people with early‑stage Parkinson’s disease by supporting the brain’s dopamine system and protecting nerve cells. It works by attaching to a protein that influences dopamine levels, helping to keep more dopamine available, and it is classified as an investigational neuroprotective agent for Parkinson’s disease.

  • Ro7568282 placebo

    This is an oral hard‑capsule that contains no active drug, used only to look like the test medication. It serves as a control in the study so researchers can compare effects with the active drug. The placebo has no therapeutic purpose and is not a medicine, but it helps ensure the trial results are reliable. It contains only inactive ingredients and is classified simply as a placebo.

Investigated diseases

Parkinson’s disease - Parkinson’s disease is a chronic brain disorder that primarily affects movement. It begins with subtle signs such as slight tremor, stiffness, or slowed movements, which gradually become more noticeable. Over time, the symptoms often spread to involve both sides of the body, leading to difficulty with balance, walking, and daily activities. The disease typically progresses slowly, with motor symptoms worsening as nerve cells that produce dopamine continue to decline.
Trial detailsLast updated 23 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524064-37-00Protocol codeBP46441Estimated enrolment163 patientsSponsorF. Hoffmann-La Roche AG

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