Safinamide for Parkinson's (NCT07761936)
Testing medication for Parkinson pain
- Trial ID
- NCT07761936
- Official Title
- Effects of Safinamide Versus Placebo on Pain in Patients With Parkinson's Disease With Motor Fluctuations: A Randomized, Controlled, Double-Blind Clinical Trial
- Goal
- Testing medication for Parkinson pain
- Phase
- PHASE3
- Status
- RECRUITING
- Sponsor
- Universita di Verona
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- PARKINSON DISEASE (Disorder), Pain, Pain Management, Parkinson Disease (PD)
- Interventions
- Safinamide, Placebo
- Registry Record Last Updated
- 2026-08-13 (this month)
- Estimated Commitment
- Lower commitment estimated from the protocol (based on: placebo or control group). This reflects time and procedures only — confirm details with the study coordinator.
Summary For Families
Researchers are testing whether the medication safinamide is better than a placebo at reducing the chronic pain people with Parkinson's often have. As an add-on to each person’s stable levodopa, participants will take safinamide or a matching placebo by mouth, 50 mg daily for one week then 100 mg daily for the next 11 weeks, with pain measured before and after 12 weeks on an 11-point pain scale. The trial is enrolling adults 18 and older who have had Parkinson's for at least three years, who have motor fluctuations and ongoing pain for more than three months despite stable levodopa doses, speak Italian, and meet other safety requirements.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Hoehn and Yahr stage 2 to 3
- Levodopa: Must be taking levodopa (criteria text: "pd-related chronic pain (lasting more than 3 months) and motor fluctuations while receiving stable doses of l-dopa (alone or with other dopaminergic treatmen...")
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "pd-related chronic pain (lasting more than 3 months) and motor fluctuations while receiving stable doses of l-dopa (alone or with other dopaminergic treatmen...")
- Motor fluctuations: Must have motor fluctuations (off periods when medication wears off) (criteria text: "* presence of motor fluctuations (> 1")
- Dyskinesia: Cannot join with significant dyskinesia (involuntary movements) (criteria text: "* patients experiencing severe, disabling peak-dose or biphasic dyskinesia, or unpredictable or widely swinging symptom fluctuations")
- Time since diagnosis: Diagnosed at least 3 years ago (criteria text: "* disease duration since diagnosis of >= 3 years")
- Thinking test (MMSE): MMSE memory and thinking score of at least 24 (criteria text: "* Evidence of dementia suggested by a Mini-Mental Scale Examination (MMSE) score \< 24.")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial requires participants to be taking levodopa.
- This trial requires a Parkinson's diagnosis at least 3 years ago.
- This trial requires motor fluctuations (off periods).
- This trial does not enroll people with significant dyskinesia.
- This trial requires Hoehn and Yahr stage 2 to 3.
- This trial requires an MMSE thinking-test score of at least 24.
Locations
- Azienda ospedaliera universitaria integrata verona, Verona, Veneto, Italy
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07761936. It is the one about "Testing medication for Parkinson pain". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take?
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 2 groups, and 1 is a placebo group. Whether you are placed in the placebo group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the placebo group would be.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Safinamide. Researchers are testing whether the medication safinamide is better than a placebo at reducing the chronic pain people with Parkinson's often have. As an add-on to each person’s stable levodopa, participants will take safinamide or a matching placebo by mouth, 50 mg daily for one week then 100 mg daily for the next 11 weeks, with pain measured before and after 12 weeks on an 11-point pain scale. The trial is enrolling adults 18 and older who have had Parkinson's for at least three years, who have motor fluctuations and ongoing pain for more than three months despite stable levodopa doses, speak Italian, and meet other safety requirements.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 1 year and 7 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Whether you are placed in the placebo group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the placebo group would be.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.