Safinamide vs Placebo for Pain in Patients With Parkinson's Disease and Motor Fluctuations
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversita di Verona
About this 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.
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Safinamide
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universita di Verona
Lead sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Sponsor institution
Source ClinicalTrials.gov