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Safinamide vs Placebo for Pain in Patients With Parkinson's Disease and Motor Fluctuations

NCT07761936 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-13

No results posted yet for this study

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.

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.

Conditions

  • PARKINSON DISEASE (Disorder)
  • Pain
  • Pain Management
  • Parkinson Disease (PD)

Interventions

DRUG

Safinamide

Safinamide administered orally once daily, starting at 50 mg for 1 week followed by 100 mg for 11 weeks.

DRUG

Placebo

Matching placebo tablets administered orally once daily according to the same schedule.

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Michele Tinazzi, MD, PhD · Università degli studi di Verona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761936 on ClinicalTrials.gov