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Safinamide

Clinical trials are investigating Safinamide in people with Parkinson’s disease. These studies look at whether it can help with fatigue and pain, and whether it is safe and effective compared with other treatments or placebo. The trials include adults with Parkinson’s disease, including those with motor fluctuations.

Table of contents

Trial overview

Two authorised Phase 3 clinical trials are studying Safinamide in people with Parkinson’s disease.[1][2] These trials are looking at different symptoms: fatigue in one study and pain in the other.[1][2]

Both studies are interventional, which means the researchers give a treatment and then measure the results.[1][2]

Fatigue study in Parkinson’s disease

The first trial is a multicenter, randomized, double-blind, parallel-group study that compares Safinamide with Rasagiline for fatigue symptoms linked to Parkinson’s disease.[1] “Randomized” means people are assigned by chance to a study group, and “double-blind” means neither the participant nor the study team knows which treatment is being used.[1]

This study plans to enroll 50 people.[1] The main result being measured is the change in the Fatigue Severity Scale (FSS) score, which is a questionnaire that shows how strong fatigue is.[1]

The brief study summary says safety will also be checked over 6 months using blood pressure, heart rate, blood tests, the Movement Disorders Society Unified Parkinson’s Disease Rating Scale part III, ECG, and reports of adverse effects.[1] These safety checks help researchers see whether the treatment is tolerated during the study period.[1]

Pain study in Parkinson’s disease with motor fluctuations

The second trial is called SAVE PAIN 2025 and studies whether Safinamide is better than placebo for reducing pain in people with Parkinson’s disease and motor fluctuations.[2] A placebo is a look-alike treatment with no active medicine, used so the results can be compared fairly.[2]

This is also a randomized, controlled, double-blind Phase 3 trial.[2] It plans to enroll 60 people.[2]

The main outcome is the change in pain score using the NRS, or numeric rating scale, after 12 weeks of treatment.[2] The study team expects to compare the Safinamide group with the placebo group to see whether pain improves more with Safinamide.[2]

The intervention list shows both active treatment and placebo forms at 50 mg and 100 mg, with the placebo made to look the same as the active tablets except for the missing active substance.[2]

Who can take part and how the studies are designed

These trials focus on adults with Parkinson’s disease, but each study targets a different symptom group.[1][2] One study includes people with fatigue symptoms linked to Parkinson’s disease, while the other includes people with Parkinson’s disease and motor fluctuations.[1][2]

The fatigue trial compares Safinamide with another active drug, Rasagiline.[1] The pain trial compares Safinamide with placebo, which helps show whether any change in pain is likely due to the study treatment and not chance alone.[2]

Because both studies are Phase 3, they are testing the treatments in a larger and more practical way than early studies.[1][2] This phase is often used to confirm benefits and continue safety monitoring before any broader use is considered.[1][2]

What the trials measure

The main goal in the fatigue trial is to see whether the FSS score changes after treatment.[1] The study also records blood pressure, heart rate, blood tests, ECG, movement rating scores, and side effects to track safety.[1]

The main goal in the pain trial is to see whether pain changes on the NRS after 12 weeks.[2] The trial description does not list extra safety measures in the same detail as the fatigue study, but it is still a controlled, double-blind study designed to compare outcomes fairly.[2]

What these trials may mean for patients

These studies show that Safinamide is being tested for symptom relief in Parkinson’s disease, not only for movement problems but also for fatigue and pain.[1][2] The research is still focused on measuring whether the treatment helps and how safe it is in the study groups.[1][2]

Because the trials are small, with 50 and 60 planned participants, the results will help researchers learn more about these specific symptoms in Parkinson’s disease.[1][2]

Trial ID Phase Condition studied Status Enrollment
2023-503713-29-00 Phase 3 Fatigue symptoms associated with Parkinson’s disease Authorised 50
2025-521512-20-00 Phase 3 Parkinson’s disease with motor fluctuations; pain Authorised 60

FAQ

  • What are the Safinamide clinical trials studying? The trials are studying whether Safinamide can help reduce fatigue and pain in people with Parkinson’s disease. They also measure safety outcomes such as blood pressure, heart rate, ECG, blood tests, and side effects.
  • Who can take part in these trials? The trials focus on adults with Parkinson’s disease. One study includes people with fatigue related to Parkinson’s disease, and another includes people with Parkinson’s disease and motor fluctuations.
  • What trial phases are being used? Both studies are Phase 3 trials. Phase 3 means the treatment is being tested in a larger group to better understand how well it works and how safe it is.
  • What treatments are being compared with Safinamide? One trial compares Safinamide with Rasagiline. Another trial compares Safinamide with placebo, which is a look-alike treatment with no active medicine.
  • What results are the trials measuring? The fatigue study measures changes in the Fatigue Severity Scale score. The pain study measures change in pain using an NRS score after 12 weeks of treatment.

Ongoing Clinical Trials on Safinamide

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

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

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Parkinson’s disease: A long-term brain condition that can cause movement problems, stiffness, and other symptoms such as fatigue or pain.
  • Fatigue: A strong feeling of tiredness or low energy that does not improve much with rest.
  • Motor fluctuations: Changes in Parkinson’s symptoms during the day, when movement control may be better at some times and worse at others.
  • Randomized: Participants are assigned by chance to different treatment groups, so the groups are compared fairly.
  • Double-blind: Neither the participant nor the study team knows which treatment is being given, which helps reduce bias.
  • Placebo: A look-alike treatment with no active medicine, used to compare results with the study drug.
  • Phase 3: A later stage of clinical testing in a larger group of people to study how well a treatment works and how safe it is.
  • Primary outcome: The main result the trial is designed to measure.
  • Fatigue Severity Scale (FSS): A questionnaire used to measure how severe fatigue is.
  • NRS: A numeric rating scale used to measure pain, usually by asking people to rate pain on a number scale.
  • ECG: A test that records the heart’s electrical activity.
  • Adverse effects: Unwanted medical problems or side effects that happen during a study.

References

  1. https://clinicaltrials.gov/study/2023-503713-29-00
  2. https://clinicaltrials.gov/study/2025-521512-20-00