PARKINSON DISEASE (Disorder)Phase 3SAVE PAINNCT07761936
Safinamide vs Placebo for Pain in Patients With Parkinson's Disease and Motor Fluctuations
A Phase 3 study testing Safinamide in people with PARKINSON DISEASE (Disorder) and Pain, run by Universita di Verona at 1 site in Italy.
Trial summary
This is a Phase III, single-center, randomized, double-blind, placebo-controlled clinical trial designed to investigate the superiority of safinamide compared to a placebo in reducing Parkinson's Disease (PD)-related pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Pain, Pain Management
- What is being tested?
- Safinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 28 Apr 2026to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)].
Show all 11Show fewer
- 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.].
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fabio Paio, MD contact
Italy1 site, 1 recruiting
- Recruiting
Azienda ospedaliera universitaria integrata verona
Verona, Veneto, 37134
Michele Tinazzi, MD, PhD, 0458124768 ext. +39, michele.tinazzi@univr.it
Fabio Paio, MD, fabio.paio@univr.it
About this study
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
This is a Phase III, single-center, randomized, double-blind, placebo-controlled clinical trial designed to investigate the superiority of safinamide compared to a placebo in reducing Parkinson's Disease (PD)-related pain.
The trial plans to enroll 60 adult patients diagnosed with PD who experience motor fluctuations and chronic pain (lasting more than 3 months) despite receiving stable doses of levodopa.
Read more
Participants will be randomized in a 1:1 ratio to receive either oral safinamide or a matching placebo as an add-on therapy. The treatment regimen consists of 50 mg/day for the first week, increasing to 100 mg/day for the remaining 11 weeks, for a total treatment duration of 12 weeks.
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 and treatment complications (UPDRS Parts III and IV, Home Diary), quality of life (PDQ-39), and other non-motor symptoms (MDS-NMS).
The total expected duration of the clinical trial is 24 months.
- Being tested
- Safinamide, Placebo
- Medical subject headings
- Parkinson Disease, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafinamideDrug
Safinamide administered orally once daily, starting at 50 mg for 1 week followed by 100 mg for 11 weeks.
PlaceboDrug
Matching placebo tablets administered orally once daily according to the same schedule.
| Study group | Role | What they receive |
|---|---|---|
| Safinamide | Active comparator | 30 Patients with PD and pain will receive oral safinamide once daily, starting at 50 mg for 1 week followed by 100 mg for 11 weeks Receives: Drug: Safinamide |
| Placebo | Placebo comparator | 30 Patients with PD and pain will receive matching placebo tablets administered orally once daily according to the same schedule. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity on the Numeric Rating Scale (NRS)
Mean change in pain intensity measured by the 11-point Numeric Rating Scale (NRS) from baseline (T0) to T1
Measured: Baseline and 12 weeks after treatment initiation
Secondary outcomes (8)
Kings Parkinson's Pain Scale (KPPS)
score
Measured: Baseline and 12 weeks after treatment initiation
Brief Pain Inventory (BPI)
score
Measured: Baseline and 12 weeks after treatment initiation
PD Pain Classification System (PD-PCS)
score
Measured: Baseline and 12 weeks after treatment initiation
Parkinson's disease Quality of Life 39 (PDQ39)
score
Measured: Baseline and 12 weeks after treatment initiation
Unified Parkinson's Disease Rating Scale (UPDRS) parts III
score
Measured: Baseline and 12 weeks after treatment initiation
Unified Parkinson's Disease Rating Scale (UPDRS) parts IV
score
Measured: Baseline and 12 weeks after treatment initiation
MDS Non-Motor Rating Scale (MDS-NMS)
score
Measured: Baseline and 12 weeks after treatment initiation
Clinical Global Impression of Change (CGI)
score
Measured: 12 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start28 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tinazzi, MD, PhD, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Michele Tinazzi, MD, PhD, Principal investigator, Università degli studi di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761936
- Sponsor's protocol ID
- 50200
- Other IDs
- 2025-521512-20-00, 2025
- Acronym
- SAVE PAIN
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07761936
- Acronym / sponsor ID
- SAVE PAIN / 50200
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, single-center, randomized, double-blind, placebo-controlled clinical trial designed to investigate the superiority of safinamide compared to a placebo in reducing Parkinson's Disease (PD)-related pain.
The trial plans to enroll 60 adult patients diagnosed with PD who experience motor fluctuations and chronic pain (lasting more than 3 months) despite receiving stable doses of levodopa.
Participants will be randomized in a 1:1 ratio to receive either oral safinamide or a matching placebo as an add-on therapy. The treatment regimen consists of 50 mg/day for the first week, increasing to 100 mg/day for the remaining 11 weeks, for a total treatment duration of 12 weeks.
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 and treatment complications (UPDRS Parts III and IV, Home Diary), quality of life (PDQ-39), and other non-motor symptoms (MDS-NMS).
The total expected duration of the clinical trial is 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safinamide | Active comparator | Drug: Safinamide30 Patients with PD and pain will receive oral safinamide once daily, starting at 50 mg for 1 week followed by 100 mg for 11 weeks |
| Placebo | Placebo comparator | Drug: Placebo30 Patients with PD and pain will receive matching placebo tablets administered orally once daily according to the same schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafinamideSafinamide administered orally once daily, starting at 50 mg for 1 week followed by 100 mg for 11 weeks. | Drug | Safinamide |
| PlaceboMatching placebo tablets administered orally once daily according to the same schedule. | Drug | Placebo |
Primary outcome
Change in Pain Intensity on the Numeric Rating Scale (NRS)
Time frame: Baseline and 12 weeks after treatment initiation
Mean change in pain intensity measured by the 11-point Numeric Rating Scale (NRS) from baseline (T0) to T1
8 secondary outcomes
Kings Parkinson's Pain Scale (KPPS)
Time frame: Baseline and 12 weeks after treatment initiation
Brief Pain Inventory (BPI)
Time frame: Baseline and 12 weeks after treatment initiation
PD Pain Classification System (PD-PCS)
Time frame: Baseline and 12 weeks after treatment initiation
Parkinson's disease Quality of Life 39 (PDQ39)
Time frame: Baseline and 12 weeks after treatment initiation
Unified Parkinson's Disease Rating Scale (UPDRS) parts III
Time frame: Baseline and 12 weeks after treatment initiation
Unified Parkinson's Disease Rating Scale (UPDRS) parts IV
Time frame: Baseline and 12 weeks after treatment initiation
MDS Non-Motor Rating Scale (MDS-NMS)
Time frame: Baseline and 12 weeks after treatment initiation
Clinical Global Impression of Change (CGI)
Time frame: 12 weeks after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Related trials for PARKINSON DISEASE (Disorder)
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Paio, MD contact
Michele Tinazzi, MD, PhD principal investigator
Università degli studi di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Safinamide in people with PARKINSON DISEASE (Disorder) and Pain, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Tinazzi, MD, PhD (0458124768 ext. +39, michele.tinazzi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity on the Numeric Rating Scale (NRS) (time frame: Baseline and 12 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.