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

NCT ID: NCT05312632

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2023-05-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safinamide Mesilate

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.

Group Type: EXPERIMENTAL

Safinamide Mesilate

Intervention Type: DRUG

Safinamide Mesilate oral tablets.

Interventions

Safinamide Mesilate

Safinamide Mesilate oral tablets.

Intervention Type: DRUG

Other Intervention Names

Equfina; ME2125

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Korea Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eisai Site #17

Gyeonggi-do, , South Korea

Eisai Site #5

Gyeonggi-do, , South Korea

Eisai Site #14

Incheon, , South Korea

Eisai Site #13

Seoul, , South Korea

Eisai Site #18

Seoul, , South Korea

Eisai Site #1

Seoul, , South Korea

Eisai Site #4

Seoul, , South Korea

Eisai Site #6

Seoul, , South Korea

Eisai Site #7

Seoul, , South Korea

Eisai Site #8

Seoul, , South Korea

Eisai Site #9

Seoul, , South Korea

Eisai Site #11

Busan, , South Korea

Eisai Site #20

Busan, , South Korea

Eisai Site #3

Busan, , South Korea

Eisai Site #16

Daegu, , South Korea

Eisai Site #2

Daegu, , South Korea

Eisai Site #19

Daejeon, , South Korea

Eisai Site #10

Gwangju, , South Korea

Eisai Site #12

Gyeonggi-do, , South Korea

Eisai Site #15

Gyeonggi-do, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 39540934 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ME2125-M082-401

Identifier Type: -

Identifier Source: org_study_id