Clinical trial NCT05312632: A Study to Evaluate the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Participants With Motor Fluctuation in South Korea
Official title: A Multi-center, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Patients With Motor Fluctuation in South Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-05
Enrollment: 201
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the change at the 18th week from baseline in daily "off" time measured by participant diary and Parkinson's Disease Questionnaire-39 (PDQ-39) in participants with Parkinson's Disease who are receiving levodopa.


Eligibility criteria: Inclusion Criteria:

1. Male or female, age greater than or equal to (\>=) 19 years at the time of informed consent
2. Participants who meet the clinical diagnostic criteria of Movement Disorder Society (MDS) diagnostic criteria 2015 for Parkinson's disease, have motor fluctuations with \>=1.5 hours of "off" time throughout the day which is confirmed at the time of Screening, and take levodopa 3 or more times a day
3. Parkinson's Disease participants who are receiving levodopa without Catechol O-methyltransferase (COMT) inhibitor and/or Monoamine oxidase-B (MAO-B) inhibitor
4. Be able to maintain an accurate and complete diary with the help of a caregiver as needed, recording "on" time, "on" time with dyskinesia, "off" time, and time asleep
5. Be able to provide written informed consent
6. Participants whose cognitive function, at the discretion of an investigator, is at a level appropriate to participate in the clinical trial (that is., with a Global Deterioration Scale \[GDS\] score of 3 or less or a Clinical Dementia Rating \[CDR\] of 0.5 or less within 3 months prior to screening)

Exclusion Criteria:

1. Females who are planning for pregnancy, pregnant or breastfeeding
2. Prior use of safinamide
3. If participants have previously taken medication such as COMT inhibitor and/or MAO-B inhibitor, they have to take appropriate wash-out period for each medication (3 days for COMT inhibitor; 14 days for MAO-B inhibitor)
4. Use of medications for depression or psychosis within 5 weeks prior to screening
5. History of allergic response to levodopa, or other anti-Parkinsonian agents
6. Hypersensitivity or contraindications to MAO-B inhibitors
7. Confirmed ophthalmologic history including any of the following conditions: albino participants, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (that is, 20/70 on Snellen Chart), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy
8. Participants who did not consent to having at least 7 days of washout period prior to visit 2, if known to take narcotic analgesics 7 days prior to screening visit (example, pethidine hydrochloride-containing products, tramadol hydrochloride, or tapentadol hydrochloride)
9. History of serotonergic medications administration (example, tricyclic antidepressants, tetracyclic antidepressants, selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, selective noradrenaline reuptake inhibitor, or noradrenergic and serotonergic antidepressant) within 5 weeks prior to screening visit
10. Administering central nervous system stimulants (example, methylphenidate hydrochloride, lisdexamfetamine mesilate)
11. Administering dextromethorphan
12. Participants with clinically significant liver function abnormalities defined as greater than (\>) 1.5 times of the upper limit of the normal range of total bilirubin or \>3 times of the upper limit of the normal range of Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST); re-examination and re-screening are allowed once within the screening period
13. Have a history of hypersensitivity to any of the ingredients of the product
14. Currently enrolled in another clinical trial or used any investigational drug/biologics or device within 30 days or 5\*the half-life, whichever is longer, preceding informed consent

Primary outcomes:
measure: Change From Baseline in Daily "OFF" Time at Week 18
timeFrame: Baseline, Week 18
measure: Change From Baseline in PDQ-39 Score at Week 18
timeFrame: Baseline, Week 18
Secondary outcomes:
measure: Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating (MDS-UPDRS) Part 3 at Week 18
timeFrame: Baseline, Week 18
measure: Change From Baseline in MDS-UPDRS Part 4 at Week 18
timeFrame: Baseline, Week 18
measure: Change From Baseline in King's Parkinson's Disease Pain Scale (KPPS) at Week 18
timeFrame: Baseline, Week 18
measure: Change From Baseline in Mini-Mental State Examination (MMSE) at Week 18
timeFrame: Baseline, Week 18
measure: Change From Baseline in Daily "ON" Time Without Dyskinesia at Week 18
timeFrame: Baseline, Week 18
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From the first dose of the study drug up to end of the treatment (up to Week 18)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Eisai Site #11
city: Busan
country: Korea, Republic of
facility: Eisai Site #20
city: Busan
country: Korea, Republic of
facility: Eisai Site #3
city: Daegu
country: Korea, Republic of
facility: Eisai Site #16
city: Daegu
country: Korea, Republic of
facility: Eisai Site #2
city: Daejeon
country: Korea, Republic of
facility: Eisai Site #19
city: Gwangju
country: Korea, Republic of
facility: Eisai Site #10
city: Gyeonggi-do
country: Korea, Republic of
facility: Eisai Site #12
city: Gyeonggi-do
country: Korea, Republic of
facility: Eisai Site #15
city: Gyeonggi-do
country: Korea, Republic of
facility: Eisai Site #17
city: Gyeonggi-do
country: Korea, Republic of
facility: Eisai Site #5
city: Incheon
country: Korea, Republic of
facility: Eisai Site #14
city: Seoul
country: Korea, Republic of
facility: Eisai Site #13
city: Seoul
country: Korea, Republic of
facility: Eisai Site #18
city: Seoul
country: Korea, Republic of
facility: Eisai Site #1
city: Seoul
country: Korea, Republic of
facility: Eisai Site #4
city: Seoul
country: Korea, Republic of
facility: Eisai Site #6
city: Seoul
country: Korea, Republic of
facility: Eisai Site #7
city: Seoul
country: Korea, Republic of
facility: Eisai Site #8
city: Seoul
country: Korea, Republic of
facility: Eisai Site #9
Study officials:
References: