--- title: Testing medication for Parkinson pain nct_id: NCT07761936 phase: PHASE3 status: RECRUITING sponsor: Universita di Verona study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT07761936" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07761936" last_fetched: "2026-08-13T14:00:08.747Z" source: "Parkinson's Pathways (curated)" --- # Testing medication for Parkinson pain **Goal (in five words):** Testing medication for Parkinson pain **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 **Trial ID:** [NCT07761936](https://clinicaltrials.gov/study/NCT07761936) ## Key Facts - **Phase:** PHASE3 - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** Universita di Verona - **Target Enrollment:** 60 participants - **Start Date:** 2026-04-28 - **Completion Date:** 2027-12 - **Conditions:** PARKINSON DISEASE (Disorder), Pain, Pain Management, Parkinson Disease (PD) - **Interventions:** Safinamide, Placebo - **Intervention Types:** DRUG - **Registry Record Last Updated:** 2026-08-13 (this month) ## 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. **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. ## What This Actually Involves **Placebo** _(From the protocol)_: 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. **Visits** _(Ask the coordinator)_: Ask the coordinator how many in-person visits the study involves, how long each one takes, and over what total period. **Procedures** _(From the protocol)_: - Questionnaires & surveys (Non-invasive) > "The primary endpoint is to evaluate the mean change in pain severity from baseline to 12 weeks, measured using the 11-point Numeric Rating Scale (NRS) Secondary endpoints will assess additional qualitative and quantitative pain characteristics (KPPS, BPI, PD-PCS), motor symptoms…" **Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long. **Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered. _Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._ ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: * Age ≥ 18 years; PD-related chronic pain (lasting more than 3 months) and motor fluctuations while receiving stable doses of L-dopa (alone or with other dopaminergic treatments) for at least 4 weeks prior to baseline (visit T0). * Diagnosis of PD according to the International Parkinson and Movement Disorders Society (MDS) clinical diagnostic criteria. * Disease duration since diagnosis of ≥ 3 years. * Presence of motor fluctuations (\> 1.5 hours OFF time/day excluding morning akinesia) * Hoehn and Yahr stage II-III during ON time. * A history of pain symptoms for the last 12 weeks \[at least 4 points scored on the Numerical Rating Scale (NRS)\]. * Willing to participate in this study and able to understand and sign the written informed consent and the form privacy data. * Be responsive to levodopa as per the MDS Clinical Diagnostic Criteria for Parkinson's disease, which define responsiveness as a clinically meaningful benefit to dopaminergic therapy, either documented objectively or subjectively. * Be on stable daily doses of oral L-dopa (including controlled release \[CR\], immediate release \[IR\] or a combination of CR/IR), with and without benserazide/carbidopa, and optionally with a catechol-O-methyltransferase (COMT) inhibitor. Participants may also be receiving stable doses of dopamine agonists, anticholinergics and/or amantadine for at least 4 weeks prior to the screening visit. * Participants must be able to speak and understand the Italian language. * If female, participants must either be post-menopausal for at least one year, as self-reported by the patient, or, if of childbearing potential, must have a negative plasma human chorionic gonadotropin (HCG) test to exclude pregnancy at screening. Additionally, if of childbearing potential, patients will be required to undergo monthly urine pregnancy testing, scheduled at approximately day 30 and day 60, and the urine test at the final visit (T1). Moreover, women of childbearing potential must agree to use a highly effective method of contraception, starting 2 months before enrollment, throughout the entire duration of the study and for at least 30 days after the last dose of the study medication. Acceptable methods of contraception include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence \[Sexual abstinence is considered an acceptable method only if it reflects the participant's consistent and preferred lifestyle.\]. Exclusion Criteria: * Concomitant therapy with monoamine oxidase B inhibitors. * Patients experiencing severe, disabling peak-dose or biphasic dyskinesia, or unpredictable or widely swinging symptom fluctuations. * De novo patients. * Evidence of dementia suggested by a Mini-Mental Scale Examination (MMSE) score \< 24. * Evidence of depression according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM V.3. * Treatment with antidepressant medications. * Signs and symptoms suggestive of atypical parkinsonism. * Severe and progressive medical illnesses other than PD. * Concomitant diseases potentially causing acute or chronic pain (i.e., rheumatologic conditions, cancer, severe polyneuropathy, and spine injuries). * Treatment with opioids, neuroleptics, barbiturates, phenothiazines, pregabalin, gabapentin. * Any other contraindication according to the current Summary of product characteristics (SmPC) of safinamide. * Previous neurosurgical intervention or stereotactic brain surgery for PD. * Concomitant infusive device-aided therapies for PD. * Drug and/or alcohol abuse within 12 months prior to the screening visit. * Use of any investigational drug or device within 30 days prior to screening or 5 half-lives (whichever is the longest), or at any point during the study. * Known allergy, sensitivity, or contraindications to the investigational medicinal products (IMPs), their excipients. * Any clinically significant condition which, in the opinion of the Investigator, would be incompatible with study participation or pose a risk to the patient during the study. * Moderate to severe liver failure as defined by the Child-Pugh classification score, or human immunodeficiency virus (HIV) infection. * Treatment with monoamine oxidase inhibitors (MAOIs), pethidine, opiates, opioids, fluoxetine, fluvoxamine within 4 weeks prior to the screening visit. These drugs are not allowed throughout the study and up 2 weeks after the last dose of study drug. * History of ophthalmologic conditions including any of the following: albinism, uveitis, retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive diabetic retinopathy, inherited retinopathy or family history of hereditary retinal disease. * Pregnancy and breastfeeding. ``` ## Locations (1) - Azienda ospedaliera universitaria integrata verona, Verona, Veneto, Italy _(45.4385, 10.9938)_ - Michele Tinazzi, MD, PhD, (CONTACT), 0458124768, michele.tinazzi@univr.it - Fabio Paio, MD, (CONTACT), fabio.paio@univr.it ## Central Contacts - Michele Tinazzi, MD, PhD, (CONTACT), 0458124768, michele.tinazzi@univr.it - Fabio Paio, MD, (CONTACT), fabio.paio@univr.it ## 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. --- *Canonical: https://parkinsonspathways.com/trial/NCT07761936* *HTML version: https://parkinsonspathways.com/trial/NCT07761936* *Source data: https://clinicaltrials.gov/study/NCT07761936*