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RECRUITING
NCT07761936
PHASE3

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

Sponsor: Universita di Verona

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-04-28

Completion Date

2027-12

Last Updated

2026-08-13

Healthy Volunteers

No

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.

Locations (1)

Azienda ospedaliera universitaria integrata verona

Verona, Veneto, Italy