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Study of safinamide compared to placebo for pain relief in patients with Parkinson's disease who experience motor fluctuations

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What is this trial about?

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

This clinical trial aims to study the effectiveness of safinamide in reducing pain in people with Parkinson's disease who experience motor fluctuations. Motor fluctuations are periods when medication becomes less effective, causing symptoms to return before the next dose. The study will compare safinamide (marketed as Xadago) against placebo in patients who are already taking levodopa or other medications for Parkinson's disease.

The medication being tested comes in two strengths - 50 mg and 100 mg film-coated tablets that are taken by mouth. During the study, some participants will receive safinamide while others will receive placebo tablets that look identical but contain no active medication. Neither the participants nor the doctors conducting the study will know who is receiving which treatment until the study is complete.

The study will last for 12 weeks, during which participants will take their assigned medication daily while continuing their regular Parkinson's disease treatments. Throughout the study, doctors will measure changes in pain levels using a rating scale that helps track if the pain is getting better or worse. They will also monitor other aspects of Parkinson's disease symptoms and how they affect daily life.

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

    Initial visit and medication start

    During the first visit, you will receive either safinamide tablets or placebo tablets (tablets without active substance)

    The tablets should be taken orally every day

    You will continue taking your regular Parkinson's disease medications, including levodopa

  2. Step 2

    Treatment period

    The treatment will continue for 12 weeks

    You will need to take the study medication daily during this period

    Your pain levels will be monitored using a numerical rating scale (a simple pain scale from 0 to 10)

    For females of childbearing potential: pregnancy tests will be conducted monthly (approximately day 30 and day 60)

  3. Step 3

    Assessment of movement symptoms

    Your movement symptoms will be evaluated during the study

    The assessment will include checking your response to medication and periods when medication is not working well (OFF time)

    Your quality of life related to Parkinson's disease will be evaluated

  4. Step 4

    Final visit

    After 12 weeks, you will have a final assessment

    Your pain levels and movement symptoms will be evaluated one last time

    For females of childbearing potential: a final pregnancy test will be conducted

Who can join the trial?

13 criteria

  • Must be 18 years or older
  • Must have Parkinson's disease diagnosed for at least 3 years
  • Must have chronic pain related to Parkinson's disease that has lasted more than 3 months
  • Must experience motor fluctuations (periods when medication is not working well, lasting more than 1.5 hours per day, not counting morning stiffness)
  • Must be taking levodopa (a medication for Parkinson's disease) at stable doses for at least 4 weeks
  • Must have shown improvement with levodopa treatment
  • Must be in stage II-III of the disease during periods when medication is working
  • Must have experienced pain scoring at least 4 points on a pain scale for the past 12 weeks
  • For women who can become pregnant:
    • Must have a negative pregnancy test before starting
    • Must agree to monthly pregnancy testing
    • Must use effective birth control starting 2 months before the study, during the study, and for 30 days after
    • Must be able to understand and sign the informed consent form
    • Must be able to speak and understand Italian

Who cannot join the trial?

13 criteria

  • History of atypical parkinsonism (a group of conditions that cause movement problems similar to Parkinson's disease but have different causes)
  • Having had neurosurgical procedures (brain surgery) for Parkinson's disease
  • Presence of other significant medical conditions that could interfere with the study assessments
  • Current treatment with medications that could interact with the study drug
  • Known allergies or sensitivity to safinamide (the study medication) or similar drugs
  • Participation in another clinical trial within the past 30 days
  • Severe liver or kidney problems
  • Uncontrolled high blood pressure
  • History of substance abuse in the past 6 months
  • Pregnant or breastfeeding women
  • Mental health conditions that could affect the ability to follow study procedures
  • Unable to provide informed consent
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

Safinamide is a medication used to treat Parkinson's disease. It works by helping to maintain dopamine levels in the brain and reducing abnormal brain signaling that causes movement problems. In this trial, researchers are specifically studying how this medication might help reduce pain that people with Parkinson's disease experience, particularly in patients who have fluctuating motor symptoms (times when their movement symptoms get better or worse throughout the day).

What is already known about the treatment

Safinamide - A prescription medication administered orally that belongs to the class of monoamine oxidase B (MAO-B) inhibitors, used in the treatment of Parkinson's disease with motor fluctuations. The drug works by increasing dopamine levels in the brain by blocking the enzyme that breaks it down, helping to reduce "off" periods when standard Parkinson's medications stop working effectively. Safinamide also has potential benefits in managing Parkinson's disease-related pain, as it affects both dopaminergic and non-dopaminergic systems in the brain, making it a unique therapeutic option in the management of Parkinson's disease symptoms.

Investigated diseases

Parkinson's Disease with Motor Fluctuations - A progressive neurological condition characterized by periods when medication's effectiveness varies throughout the day, causing alternating periods of good mobility and poor movement control. During these fluctuations, patients experience changes between periods of being "on," when medications are working well and symptoms are controlled, and being "off," when medications are not working effectively and symptoms become more pronounced. The motor fluctuations typically include tremors, muscle stiffness, slow movement, and difficulties with balance and coordination. These symptoms can vary in intensity throughout the day, making daily activities unpredictable. The fluctuations often become more noticeable as the disease progresses and can significantly impact the person's ability to perform regular activities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521512-20-00Protocol codeSAVE PAIN 2025Estimated enrolment60 patientsSponsorAzienda Ospedaliera Universitaria Integrata Verona

sourced from the EU Clinical Trials Register and site verification

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