Parkinson's Disease
Conditions
Keywords
MAO inhibitors, motor fluctuations, dyskinesia, Parkinson's Disease
Brief summary
Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in humans. Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and tolerability of safinamide in PD patients, that have already completed a previous clinical study with Safinamide. The physical and neurological conditions as well as other safety parameters will get compared from baseline to subsequent visits.
Interventions
DRUGSafinamide
The Investigational Medicinal Product will be provided by the Sponsor in the form of tablets at dosage strengths of safinamide 50 mg (small - 7 mm) or safinamide 100 mg (large - 9 mm). Trial Medication is to be taken once daily, in the morning.
Sponsors
Newron Pharmaceuticals SPA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. the subject has completed a previous clinical study with Safinamide in PD 2. the subject successfully completed all trial requirements of the antecedent trial 3. if female, they must be either post-menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential, they must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of study medication. For the purpose of this trial women of child bearing potential are defined of all female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive 4. subjects must be willing and able to participate in the trial and provide written informed consent
Exclusion criteria
1. the subject experienced a clinically significant adverse effect to attributable to Investigational Medicinal Product (IMP) during a previous trial that could put the subject at risk for further treatment with Safinamide 2. if female, the subject is pregnant or lactating 3. any medical issues, which have emerged since the initial clinical trial, that in the opinion of the investigator precludes a subject's ability to participate in this open-label trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Ophthalmologic Exams | Anticipated time frame up to 3 years |
| Summary of Participants who had Adverse Experiences | Anticipated time frame up to 3 years |
| Change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) | Anticipated time frame up to 3 years |
| Change from baseline in Dermatologic Exams | Anticipated time frame up to 3 years |
| Change from baseline in Physical Exams | Anticipated time frame up to 3 years |
| Change from baseline in Neurologic Exams | Anticipated time frame up to 3 years |
| Change from baseline in Vital Signs | Anticipated time frame up to 3 years |
| Change from baseline in Laboratory Evaluations | Anticipated time frame up to 3 years |
| Change from baseline in Electrocardiograms | Anticipated time frame up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in EuroQol Group EQ-5D™ Quality of Life Scale | Anticipated time frame up to 3 years |
| Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39) | Anticipated time frame up to 3 years |
| Change from baseline in Health Resource Utilisation | Anticipated time frame up to 3 years |
Countries
Romania
Outcome results
None listed