None listed
Conditions
Interventions
Safinamide Type of group
Safinamide to be taken orally, once a day (50 or 100 mg / day), in the morning, in addition to the morning dose of another medication for PD.
Sponsors
NEWRON PHARMACEUTICALS SpA.,
Eligibility
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: • The subject has completed a previous clinical study with safinamide in PD, and; • The subject successfully completed all the requirements of the previous study, and; • For patients for whom this open study is not yet available due to a longer implementation of the study in the centers, the maximum period of time without safinamide treatment is 12 months. Note: If the last visit of the previous study cannot be used as the baseline evaluation of the open study, a complete baseline examination should be performed. • If you are a woman, you must be postmenopausal for at least 2 years, have been surgically sterilized or have undergone a hysterectomy or, if you are of childbearing age, you must be willing to avoid pregnancy by using an appropriate contraceptive method for four weeks before the study, during the same and four weeks after the last dose of the study medication. For the purpose of this study, women of childbearing age are defined as all women after puberty unless they are postmenopausal for at least 2 years, have been surgically sterilized or sexually inactive, and; • Subjects must be willing and able to participate in this study and give written informed consent.
Exclusion criteria
Exclusion criteria: • The subject presented a clinically significant adverse effect attributable to the medicinal product under investigation during a previous study that could put the subject at risk if he continues with safinamide treatment. • If you are a woman, you are pregnant or breastfeeding • Any medical problem that has arisen from the initial clinical study that, at the discretion of the researcher, prevents the subject from participating in this open study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:All findings observed during physical and neurological exams will be entered into the CRF. Abnormal results must be specified: the neurological examination will include mental status, cranial nerves, motor exam, reflexes, sensory exam, cerebellar exam and gait. Vital signs will be evaluated at all scheduled evaluation visits. The UPDRS is a scoring tool used to follow the longitudinal course of PD. A trained ophthalmologist will perform a complete ophthalmologic examination, including the fundus, of all subjects. A trained dermatologist will perform a complete dermatological examination of each subject Measure:Change from baseline evaluation of physical and neurological exams, vital signs, laboratory analysis, electrocardiograms, AE, UPDRS, dermatological exams and ophthalmological exams. Timepoints:Up to 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:In order to estimate the cost of the treatment regimen used in the study, the study center staff will complete the information related to the use of healthcare resources for all subjects. During the study, the HRU will be evaluated, such as hospitalizations, doctor visits, outpatient treatments and visits to the emergency department. The data will be analyzed and descriptive statistics will be reported (mean, median, standard deviation, minimum and maximum values). Measure:Change from baseline in Health Resource Utilisation Timepoints:Up to 3 years ; Outcome name:The EQ-5D is a standardized instrument to be used as a measure of health outcome. It offers a simple descriptive profile and a unique index of health status and has been used in various health conditions. The EQ-5D includes measures of unique components of five dimensions of health: mobility, self-care, habitual activities, pain / discomfort and anxiety / depression. Measure:Change from baseline in EuroQol Group EQ-5D Quality of Life Scale Timepoints:Up to 3 years ; Outcome name:The PDQ-39 comprises 39 questions that measure eight dimensions of health: mobility, activities of daily living, emotional well-being, stigma, social support, cognitive function, communication and body pain. The scores of the dimensions are assigned on a scale that ranges from 0 (perfect health according to the measure) to 100 (worse state of health according to the measure). It is also possible to calculate a global index score. Measure:Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39) Timepoints:Up to 3 years | — |
Contacts
Public ContactElvira Mogrovejo
IQVIA RDS Peru S.R.L
Outcome results
None listed