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

ConditionsPARKINSON DISEASE (Disorder)Pain Pain Management Parkinson Disease (PD)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Safinamide
Drug
Safinamide administered orally once daily, starting at 50 mg for 1 week followed by 100 mg for 11 weeks.
Placebo
Drug
Matching placebo tablets administered orally once daily according to the same schedule.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: SafinamideActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame