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

NCT05312632 | Completed Phase 4 Results

• 1 other identifier: ME2125-M082-401
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 20

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Daily "OFF" Time at Week 18

  Participants received diary card and information on daily 'off' time and 'on' time was collected. At 30-minutes intervals throughout the period, the participant/caregiver recorded whether the participant was in an "on" phase, in an "on" phase with dyskinesia, in an "off" phase, or asleep. An "off" phase was defined as lack of mobility, bradykinesia, or akinesia whereas in an "on" phase, the participant functioned as well as can be expected for that participant, irrespective of whether or not he or she is having dyskinesia. The daily "off" time was defined as the mean of the total daily "off" time during the last two 24 hours dairy recording periods.

  Baseline, Week 18

• Change From Baseline in PDQ-39 Score at Week 18

  The PDQ-39 was a self-reported outcome or rater-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-30), cognition (Questions 31-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question was answered on a 5-point scale from 0 (Never) to 4 (Always/Cannot Do At All). Scores were calculated by summing the answers to the questions in the domain and converting to a total score scale from 0 to 100. Higher scores were associated with the more severe symptoms of the disease such as tremor and stiffness.

  Baseline, Week 18

Secondary Outcomes (6)

• Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating (MDS-UPDRS) Part 3 at Week 18

  Baseline, Week 18

• Change From Baseline in MDS-UPDRS Part 4 at Week 18

  Baseline, Week 18

• Change From Baseline in King's Parkinson's Disease Pain Scale (KPPS) at Week 18

  Baseline, Week 18

• Change From Baseline in Mini-Mental State Examination (MMSE) at Week 18

  Baseline, Week 18

• Change From Baseline in Daily "ON" Time Without Dyskinesia at Week 18

  Baseline, Week 18

Study Arms (1)

Safinamide Mesilate

EXPERIMENTAL

Participants with parkinson's disease will be administered Safinamide Mesilate 50 milligram (mg) tablet, orally, once daily as add-on therapy to levodopa for up to 2 weeks. After 2 weeks, at the discretion of an investigator, dose of Safinamide Mesilate will be increased to 100 mg tablets (two tablets of 50 mg each), orally, once daily for up to 18 weeks.

Drug: Safinamide Mesilate

Interventions

Safinamide Mesilate DRUG

Safinamide Mesilate oral tablets.

Also known as: Equfina, ME2125

Safinamide Mesilate

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age greater than or equal to (\>=) 19 years at the time of informed consent
• 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
• Parkinson's Disease participants who are receiving levodopa without Catechol O-methyltransferase (COMT) inhibitor and/or Monoamine oxidase-B (MAO-B) inhibitor
• 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
• Be able to provide written informed consent
• 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)

You may not qualify if:

• Females who are planning for pregnancy, pregnant or breastfeeding
• Prior use of safinamide
• 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)
• Use of medications for depression or psychosis within 5 weeks prior to screening
• History of allergic response to levodopa, or other anti-Parkinsonian agents
• Hypersensitivity or contraindications to MAO-B inhibitors
• 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
• 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)
• 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
• Administering central nervous system stimulants (example, methylphenidate hydrochloride, lisdexamfetamine mesilate)
• Administering dextromethorphan
• 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
• Have a history of hypersensitivity to any of the ingredients of the product
• 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

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (20)

Eisai Site #11

Busan, South Korea

Location

Eisai Site #20

Busan, South Korea

Location

Eisai Site #3

Busan, South Korea

Location

Eisai Site #16

Daegu, South Korea

Location

Eisai Site #2

Daegu, South Korea

Location

Eisai Site #19

Daejeon, South Korea

Location

Eisai Site #10

Gwangju, South Korea

Location

Eisai Site #12

Gyeonggi-do, South Korea

Location

Eisai Site #15

Gyeonggi-do, South Korea

Location

Eisai Site #17

Gyeonggi-do, South Korea

Location

Eisai Site #5

Gyeonggi-do, South Korea

Location

Eisai Site #14

Incheon, South Korea

Location

Eisai Site #13

Seoul, South Korea

Location

Eisai Site #18

Seoul, South Korea

Location

Eisai Site #1

Seoul, South Korea

Location

Eisai Site #4

Seoul, South Korea

Location

Eisai Site #6

Seoul, South Korea

Location

Eisai Site #7

Seoul, South Korea

Location

Eisai Site #8

Seoul, South Korea

Location

Eisai Site #9

Seoul, South Korea

Location

Related Publications (1)

• Oh E, Cheon SM, Cho JW, Sung YH, Kim JS, Shin HW, Kim JM, Park MY, Kwon DY, Ma H 2nd, Park JH, Koh SB, Choi SM, Park J, Lee PH, Ahn TB, Kim SJ, Lyoo CH, Lee HW, Kim J, Lee Y, Baik JS. Efficacy and safety of safinamide in Parkinson's disease patients with motor fluctuations without levodopa dosage escalation over 18 weeks: KEEP study. J Neural Transm (Vienna). 2025 Mar;132(3):431-441. doi: 10.1007/s00702-024-02851-6. Epub 2024 Nov 14.

  PMID: 39540934 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Serena SoYoun Kwon
• Organization: Eisai Korea Inc. Medical department

s-kwon@eisaikorea.com

+82-10-7409-5623

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: April 5, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

KR (20)