A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients
- Conditions
- •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•A stable (4 weeks since last modification) anti-parkinsonian therapy•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)MedDRA version: 21.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-004892-11-IT
- Lead Sponsor
- OSPEDALE SANTA MARIA DELLA MISERICORDIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 128
•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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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