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Study on Safinamide and Rasagiline for Treating Fatigue in Parkinson's Disease Patients on Stable Dopaminergic Treatment

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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 often includes symptoms like tremors, stiffness, and difficulty with balance and coordination. The study specifically looks at people with Parkinson's Disease who experience persistent fatigue, which is a common symptom that can significantly impact daily life. The trial will compare two treatments: Safinamide and Rasagiline. Both are medications taken orally in tablet form and are used to help manage symptoms of Parkinson's Disease.

The purpose of the study is to evaluate the safety and effectiveness of these two medications in reducing fatigue associated with Parkinson's Disease. Participants will be randomly assigned to receive either Safinamide at a dose of 100 mg per day or Rasagiline at a dose of 1 mg per day. The study will last for 24 weeks, during which time participants will continue their usual Parkinson's treatment while adding one of these medications. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know which medication each participant is receiving, to ensure unbiased results.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their symptoms. This will include measuring blood pressure, heart rate, and conducting blood tests. Additionally, participants will be assessed using the Movement Disorders Society Unified Parkinson's Disease Rating Scale part III (MDS UPDRS-III), which helps evaluate the severity of Parkinson's symptoms. The study aims to provide valuable information on how these medications can help manage fatigue in people with Parkinson's Disease.

The research process

The trial runs in 5 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, eligibility is confirmed based on specific criteria such as age, diagnosis of Parkinson's Disease, and presence of fatigue symptoms.

    Written consent is required to participate in the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one group receives safinamide (100 mg per day) and the other group receives rasagiline (1 mg per day).

    The assignment is double-blind, meaning neither the participants nor the researchers know which treatment is being administered to each participant.

  3. Step 3

    Treatment phase

    The treatment lasts for 24 weeks, during which the assigned medication is taken orally every day.

    Participants continue their stable dopaminergic treatment alongside the study medication.

  4. Step 4

    Monitoring and assessments

    Throughout the study, various health parameters are monitored, including blood pressure, heart rate, and results from blood tests.

    The Movement Disorders Society Unified Parkinson's Disease Rating Scale part III (MDS UPDRS-III) is used to assess motor symptoms.

    Electrocardiograms (ECG) are conducted, and any adverse effects are recorded.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is measured by changes in the Fatigue Severity Scale (FSS) score.

    The study aims to evaluate the safety and efficacy of the medications in reducing fatigue associated with Parkinson's Disease.

Who can join the trial?

7 criteria

  • Participants can be of any gender and must be between 50 and 80 years old.
  • Participants must have been diagnosed with Parkinson's Disease for at least three years. This diagnosis should be based on specific criteria and confirmed by a medical history and a neurological exam.
  • Participants must have brain scans that are consistent with Parkinson's Disease.
  • Participants should be in stages I to IV of the Hoehn and Yahr scale during their "ON" phase. This scale measures the severity of Parkinson's Disease.
  • Participants must have experienced fatigue for at least one month before the first visit. This is measured by a specific fatigue scale, and the score should be 8 or higher.
  • Participants should be on a stable dose of levodopa (a common medication for Parkinson's Disease) either alone or with other medications for at least four weeks before the screening visit.
  • Participants must be able to provide written consent to join the study.

Who cannot join the trial?

4 criteria

  • Patients who are not experiencing fatigue symptoms related to Parkinson's Disease cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who do not meet the gender requirements for the study are not eligible.
  • People who are considered part of a vulnerable population are not allowed to join the study.
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Investigated drugs

  • Safinamide

    is a medication used in this trial as an additional treatment for people with Parkinson's Disease who are already on stable dopaminergic therapy but still experience persistent fatigue. It is being tested to see if it can help improve symptoms when taken daily for 24 weeks.

  • Rasagiline

    is another medication being tested in this trial. Like Safinamide, it is used as an additional treatment for Parkinson's Disease patients who continue to experience fatigue despite stable dopaminergic therapy. The trial aims to evaluate its safety and effectiveness over a 24-week period.

What is already known about the treatment

  • Safinamide

    Safinamide is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating fatigue symptoms associated with Parkinson's Disease. It is an approved medication used as an add-on treatment for patients already on stable dopaminergic therapy. Safinamide works by inhibiting monoamine oxidase B (MAO-B) and modulating glutamate release, which helps to increase dopamine levels in the brain and improve motor function. It is classified as a selective MAO-B inhibitor.

  • Rasagiline

    Rasagiline is also administered orally in tablet form and is being evaluated in clinical trials for its role in managing fatigue symptoms in Parkinson's Disease. It is an established medication used as an adjunct therapy for patients on stable dopaminergic treatment. Rasagiline functions by selectively inhibiting monoamine oxidase B (MAO-B), leading to increased dopamine levels in the brain, which can enhance motor control. It belongs to the pharmacological class of selective MAO-B inhibitors.

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. Over time, individuals may experience a slowing of movement and changes in speech and writing. Fatigue is a common symptom associated with Parkinson's Disease, impacting daily activities and quality of life. The disease progresses gradually, with symptoms worsening over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503713-29-00Protocol codeIIBSP-FAT-2023-24Estimated enrolment50 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).