• Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD • A Modified Hoehn and Yahr stage of = 4 in the “off” state
Conditions
Interventions
Trade Name: XADAGO - 100 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE
Product Name: Xadago
Product Code: [043906039]
Pharmaceutical Form: Tablet
INN or Propo
Sponsors
OSPEDALE SANTA MARIA DELLA MISERICORDIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD according to UK Brain Bank diagnostic criteria; • A Modified Hoehn and Yahr stage of = 4 in the “off” state; • A stable (4 weeks since last modification) anti-parkinsonian therapy, always including levodopa (L- dopa)/dopa-decarboxylase inhibitor (DDI); • 1 month wash out is needed if patient received other MAO-B inhibitors; • The presence of FOG (defined as the persistence of gait hesitation and failure in starting the gait or the reported sensation of having the legs “frozen” or “glued to the ground”) even on an optimized dopaminergic treatment (patients with FOG item 3 score >0) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: Subjects with other severe neurological or systemic concomitant conditions, sensory deficits, clear signs of peripheral neuropathy or orthopaedic comorbidities which may interfere with gait; • Patients for whom Safinamide is contraindicated according to the current SmPC. Female subjects with ongoing or lactating or fertile pregnancy who do not adopt or intend to use adequate methods of contraception for the duration of the study. Individuals who agree to use a reliable contraceptive method during the study will be admitted (for example: more prophylactic oral contraceptive, intrauterine device (DIU or IUD) more prophylactic, diaphragm with more prophylactic spermicide). Subjects with sterile partners (eg vasectomy) and menopausal subjects for at least 1 year or surgically sterile may be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of safinamide, added to standard treatment, on FOG in fluctuating PD patients;Secondary Objective: To verify the impact of safinamide on Quality of life (QoL) and Motor scores in fluctuating PD patients;Primary end point(s): Change from baseline in the FOG-scale (= 3 points);Timepoint(s) of evaluation of this end point: 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in UPDRS, FES-I, TUG and PDQ-39;Timepoint(s) of evaluation of this end point: 14 weeks | — |
Countries
Italy
Contacts
Public ContactS.C. Clinica Neurologica
Azienda Ospedaliera di Perugia
Outcome results
None listed