Observational study of Safinamide as add-on to levodopa monotherapy for Parkinson's disease patients with wearing-off in Japan

Observational study of Safinamide as add-on to levodopa monotherapy for Parkinson's disease patients with wearing-off in Japan - J-SILVER study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044341

Enrollment

Registered

2021-05-28

Start date

2021-04-23

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Parkinson&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients who have fully understood the research contents and voluntarily provided a written informed consent to participate in this study. (2)Patients over 20 years old at the time of informed consent. (No upper age limit.) (3)Patients diagnosed with Parkinson's disease based on the International Parkinson and Movement Disorder Society (MDS) diagnostic criteria (2015) (4)Patients who are using oral levodopa-containing formulation(excluding levodopa/carbidopa hydrate/entacapone combination drug) and have a predictable wearing-off phenomenon at the time of disappearance of drug efficacy, and whose effects of monotherapy with levodopa-containing formulation are insufficient. (5)Patients who will receive combination therapy with safinamide. (6)Be able to record patient diary for 4 days or more of the last 7 days at baseline (week 0)

Exclusion criteria

Exclusion criteria: (1)Patients who received treatment with antiparkinsonian drugs other than oral levodopa-containing formulation within 4 weeks prior to baseline (week 0). (2)Patients who are planning brain surgery (destructive surgery, deep brain stimulation, etc.) for Parkinson's disease (3)Patients with severe liver dysfunction (Child-Pugh classification C) (4)Patients with a history of hypersensitivity to safinamide components (5)Patients with psychiatric disorders that may affect performance of scheduled examination. (6)Patients who are pregnant or may be pregnant. (7)Patients who principal investigator / coordinator have judged inappropriate to participate in this study

Design outcomes

Primary

Measure	Time frame
<Parkinson's disease symptom assessment> Patient diary (Off-time, On-time) MDS-UPDRS(MDS-Unified Parkinson's Disease Rating Scale) part I, III, IV <QOL assessment> PDQ-39(Parkinson's disease questionnaire-39) <Overall improvement assessment> CGI-I(Clinical Global Impression-Improvement) PGI-I(Patient Global Impression-Improvement) <Pain assessment> NRS(Numerical Rating Scale) KPPS(King's Parkinson's Disease Pain Scale) <Actigraph assessment> Body movement, Energy consumption, Strength-related indicators, Walking, Sleep	—

Measure

Time frame

<Parkinson's disease symptom assessment> Patient diary (Off-time, On-time) MDS-UPDRS(MDS-Unified Parkinson's Disease Rating Scale) part I, III, IV <QOL assessment> PDQ-39(Parkinson's disease questionnaire-39) <Overall improvement assessment> CGI-I(Clinical Global Impression-Improvement) PGI-I(Patient Global Impression-Improvement) <Pain assessment> NRS(Numerical Rating Scale) KPPS(King's Parkinson's Disease Pain Scale) <Actigraph assessment> Body movement, Energy consumption, Strength-related indicators, Walking, Sleep

—

Countries

Japan

Contacts

Public ContactFumio Kusano

APO PLUS STATION CO., LTD. Clinical Operations Department

f-kusano@apoplus.co.jp03-6386-8800

Outcome results