ong-term effect of safinamide on motor and non-motor symptoms of Parkinson’s disease
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0008194
- Lead Sponsor
- Jeonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
1. Diagnosis of Parkinson’s disease according to the United Kingdom Parkinson’s Disease Society Brain Bank criteria.
2. Subjects for whom the decision to initiate Safinamide has been made, according to the judgment of the investigator, who is the neurologist specialized in movement disorder. (The judgement is based on existing evidence and reports on symptoms that have previously reported to be improved by safinamide, which includes the presence of motor fluctuation.)
3. Stable dopaminergic treatment in the last 4 weeks. (Patients already taking other iMAO-B, such as rasagiline or selegiline, were switched to safinamide 50 mg after a 2-week wash-out period)
4. To wish to voluntarily participate and to sign a consent form.
1. other disabling concomitant neurological disease (stroke, severe head trauma, neurodegenerative disease, etc.) or other severe and disabling concomitant non-neurological disease (oncological, autoimmune, etc.)
2. incapacity to complete the questionnaires adequately
3. Contraindication to be treated with safinamide according to product data.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The 48-week long-term overall effect of safinamide on motor and non-motor symptoms and the degree of improvement in quality of life : K-NMSS, MDS-UPDRS, PDQ 39
- Secondary Outcome Measures
Name Time Method Effects of Safinamide on Psychiatric Symptoms based on the questionnaire of neuropsychiatric inventory: Korean Version of NPI-Q;Effects of safinamide on individual motor symptoms and individual non-motor symptoms in Parkinson's disease: K-NMSS, MDS-UPDRS