Safinamide mesylate NCT07761936 Clinical Landscape 2026

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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.

Data snapshot: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 3

Clinical phase

Recruiting

Recruitment status

60

Planned enrollment

2027-12-01

Primary-completion proxy

Executive view

NCT07761936 evaluates Safinamide mesylate in Young onset Parkinson disease. The disclosed sponsor is University of Verona, the design is Interventional, and the geographic footprint is Italy. The first listed primary endpoint is Change in Pain Intensity on the Numeric Rating Scale (NRS), assessed over Baseline and 12 weeks after treatment initiation.

The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.

PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.

How the MCP evidence stack was assembled

Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07761936 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Young onset Parkinson disease landscape. Drug & Asset MCP drug_fetch was queried for Safinamide mesylate, while Company & Deal Intelligence MCP organization_fetch was queried for University of Verona.

This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.

Trial landscape table

Trial	Asset / intervention	Phase / status	Sponsor	Geography	Primary endpoint	Readout proxy
NCT07761936	Safinamide mesylate	Phase 3 / Recruiting	University of Verona	Italy	Change in Pain Intensity on the Numeric Rating Scale (NRS) Baseline and 12 weeks after treatment initiation	2027-12-01
NCT07781644	RO-7568282	Phase 1/2 / Not yet recruiting	Hoffmann-La Roche Ltd.	Geography not reported	Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score Up to at least Week 104	2028-12-15
NCT07777484	TRB-001 (Tridem Bioscience)	Phase 1 / Recruiting	Tridem Bioscience	Austria	Incidence of local and systemic treatment-emergent adverse events (TEAEs) 6 months	2026-12-01
NCT07718659	ZR001	Phase 1 / Not yet recruiting	Qianfoshan Hospital of Shandong Province	China	The incidence of adverse events and serious adverse events after ZR001 treatment 52 weeks	2029-12-01

The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.

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Protocol design and endpoint interpretation

NCT07761936 is a Phase 3, recruiting study with 60 planned participants. Allocation is Randomized, masking is Triple, and the intervention model is Parallel Assignment.

The primary endpoint is “Change in Pain Intensity on the Numeric Rating Scale (NRS)” over “Baseline and 12 weeks after treatment initiation.” The retrieved endpoint description is: Mean change in pain intensity measured by the 11-point Numeric Rating Scale (NRS) from baseline (T0) to T1.

Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 60 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.

Indexed readouts in the surrounding landscape

5 recent result records were selected as contextual evidence for Young onset Parkinson disease. These records do not establish direct evidence for NCT07761936 unless the registration number matches.

Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study

Phase 2; n=12; 7 days following first drug dose(Mean) = 56.455 Total score (Standard Deviation, 19.154) Source: https://clinicaltrials.gov/ct2/show/results/NCT04932434

A Randomized, Double-blind, Placebo-controlled Trial of Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease

Phase 2; n=45; Bayesian Mean Estimate of the Proportion of Participants Achieving a ≥5-point Improvement on MDS-UPDRS Part III From Screening to Week 62, Compared Between Each Active MSC Dose Arm and Placebo(Mean) = 94.4 percentage of participants (95% Confidence Interval, 74.7 - 99.7); Bayesian Mean Estimate of the Proportion of Participants Achieving a ≥5-point Improvement on MDS-UPDRS Part III From Screening to Week 62, Compare… Source: https://clinicaltrials.gov/ct2/show/results/NCT04506073

Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients

Early Phase 1; n=31; Augmentation Index(Mean) = 30 Percentage (Standard Deviation, 25); Augmentation Index(Mean) = -20 Percentage (Standard Deviation, 7) Source: https://clinicaltrials.gov/ct2/show/results/NCT04620382

Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.

Asset and sponsor context

Safinamide mesylate is indexed as Small molecule drug with MAO-B biology and a global stage of Approved. The asset profile lists Newron Pharmaceuticals SpA as an originator or developer.

University of Verona is indexed in Italy with the website http://www.univr.it. University of Verona is a university located in Verona, Italy. The record lists 4 development-stage drug assets.

For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.

Development white space

Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
Sequencing white space. Clarify whether Safinamide mesylate is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.

White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.

Strategic implications and next readouts

For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.

For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.

Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.

Source trail and bottom line

Anchor trial: NCT07761936
Protocol source: https://clinicaltrials.gov/study/NCT07761936
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 16 September 2026.

Safinamide mesylate in Young onset Parkinson disease is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Change in Pain Intensity on the Numeric Rating Scale (NRS) and 2027-12-01 the leading decision points.

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Safinamide mesylate in Young onset Parkinson disease: NCT07761936 Clinical Landscape Report 2026