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Long-term effect of safinamide on motor and non-motor symptoms of Parkinson’s disease

Long-term effect of safinamide on motor and non-motor symptoms of Parkinson’s disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0008194
Enrollment
50
Registered
2023-02-16
Start date
2023-03-08
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Jeonbuk National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactYun Su Hwang

Jeonbuk National University Hospital

ghkddbstn11@gmail.com+82-63-250-1590

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026