Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-12 @ 9:58 AM
Study NCT ID:
NCT05312632
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2022-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's-kwon@eisaikorea.com', 'phone': '+82-10-7409-5623', 'title': 'Serena SoYoun Kwon', 'organization': 'Eisai Korea Inc. Medical department'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of the study drug up to end of the treatment (up to Week 18)', 'description': 'The safety analysis population included participants who received at least 1 dose of study drug and completed at least 1 post-dose safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received safinamide mesilate 50 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks.", 'otherNumAtRisk': 199, 'deathsNumAtRisk': 199, 'otherNumAffected': 56, 'seriousNumAtRisk': 199, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}], 'seriousEvents': [{'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Daily "OFF" Time at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received safinamide mesilate 50 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-11.2', 'upperLimit': '3.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 18', 'description': '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.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included participants who received at least 1 dose of study drug and had at least 1 record of daily "off" time or the Parkinson\'s disease questionnaire (PDQ-39) after dosing. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in PDQ-39 Score at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received safinamide mesilate 50 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'spread': '10.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 18', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least 1 dose of study drug and had at least 1 record of daily "off" time or PDQ-39 after dosing.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating (MDS-UPDRS) Part 3 at Week 18", 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received safinamide mesilate 50 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '8.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 18', 'description': "MDS-UPDRS rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living; Part 2: Motor aspects of experiences of daily living; Part 3: Motor examination; Part 4: Motor complications. Part 3 section of scale consisted of 18 items, with 33 separate ratings being performed on scale from 0 (normal) to 4 (severe). The total score ranged from 0 to 132, with a lower score=better motor function; higher score=more severe motor symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least 1 dose of study drug and had at least 1 record of daily "off" time or PDQ-39 after dosing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MDS-UPDRS Part 4 at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received safinamide mesilate 50 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 18', 'description': "The MDS-UPDRS rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts that assess: Part 1: Non-motor aspects of experiences of daily living; Part 2: Motor aspects of experiences of daily living; Part 3: Motor examination; Part 4: Motor complications. Part 4 raters use historical/objective information to assess 2 motor complications, dyskinesias and motor fluctuations including OFF-state dystonia. Raters use information from participant, caregiver, and the examination to answer 6 questions. The duration of disability caused and functional impact of any dyskinesias experienced by the participant were rated on a scale of 0 to 4. 6 items being performed on scale from 0 (normal) to 4 (severe), where the total score ranged from 0 to 24, lower score indicated better motor function and higher score indicated more severe motor symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least 1 dose of study drug and had at least 1 record of daily "off" time or PDQ-39 after dosing.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in King's Parkinson's Disease Pain Scale (KPPS) at Week 18", 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received safinamide mesilate 50 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '11.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 18', 'description': "KPPS is a Parkinson's Disease-specific pain scale that evaluated the localization, frequency, and intensity of pain. It has 14 items in 7 domains: 1. Musculoskeletal pain; 2. Chronic pain; 3. Fluctuation-related pain; 4. Nocturnal pain; 5. Oro-facial pain; 6. Discoloration, Oedema/Swelling pain; 7. Radicular pain. Each item was scored by severity (0 \\[none\\] to 3 \\[very severe\\]) multiplied by frequency (0 \\[never\\] to 4 \\[all the time\\]), resulting in a subscore of 0 to 12, the sum of which gives the total score which ranged from 0 to 168. Higher scores indicated more severity and frequency of pain.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least 1 dose of study drug and had at least 1 record of daily "off" time or PDQ-39 after dosing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mini-Mental State Examination (MMSE) at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received safinamide mesilate 50 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '1.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.053', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 18', 'description': 'The MMSE is a brief practical screening test for cognitive dysfunction. The test consists of 5 sections (orientation, registration, attention and calculation, recall, and language) and has a total possible score of 30. Total scores ranged from 0 (most impaired) to 30 (no impairment). MMSE used to assess the severity of cognitive dysfunction, with a higher score indicating better cognitive state.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least 1 dose of study drug and had at least 1 record of daily "off" time or PDQ-39 after dosing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily "ON" Time Without Dyskinesia at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received safinamide mesilate 50 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '10.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 18', 'description': 'Participants received diary card and information on daily \'off\' time and \'on\' time was collected. At 30-minute intervals throughout the period, the participant/caregiver recorded whether the participant was in an "on" phase, 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 "on" time was defined as the sum of the time without dyskinesia during the on phase to number of days completed in the diary.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least 1 dose of study drug and had at least 1 record of daily "off" time or PDQ-39 after dosing. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received safinamide mesilate 50 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks."}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of the study drug up to end of the treatment (up to Week 18)', 'description': 'A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. SAE was any untoward medical occurrence that at any dose: results in death, was life-threatening, inpatient hospitalization, requires prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), was a medically significant event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included participants who received at least 1 dose of study drug and completed at least 1 post-dose safety assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}]}, {'type': 'Safety Analysis Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}]}, {'type': 'Full Analysis Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Non-compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 20 investigative sites in South Korea from 05 April 2022 to 25 May 2023.', 'preAssignmentDetails': 'A total of 222 participants were screened, of which 21 were screen failures and 201 were enrolled and treated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Safinamide Mesilate 100 mg', 'description': "Participants with parkinson's disease received safinamide mesilate 50 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 was increased to 100 mg (two tablets of 50 mg each), orally, once daily for up to 18 weeks."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '199', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Not Hispanic or Latino', 'measurements': [{'value': '199', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis population included participants who received at least 1 dose of study drug and completed at least 1 post-dose safety assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-24', 'size': 1695783, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-23T08:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2022-03-28', 'resultsFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-23', 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Daily "OFF" Time at Week 18', 'timeFrame': 'Baseline, Week 18', 'description': '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.'}, {'measure': 'Change From Baseline in PDQ-39 Score at Week 18', 'timeFrame': 'Baseline, Week 18', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating (MDS-UPDRS) Part 3 at Week 18", 'timeFrame': 'Baseline, Week 18', 'description': "MDS-UPDRS rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living; Part 2: Motor aspects of experiences of daily living; Part 3: Motor examination; Part 4: Motor complications. Part 3 section of scale consisted of 18 items, with 33 separate ratings being performed on scale from 0 (normal) to 4 (severe). The total score ranged from 0 to 132, with a lower score=better motor function; higher score=more severe motor symptoms."}, {'measure': 'Change From Baseline in MDS-UPDRS Part 4 at Week 18', 'timeFrame': 'Baseline, Week 18', 'description': "The MDS-UPDRS rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts that assess: Part 1: Non-motor aspects of experiences of daily living; Part 2: Motor aspects of experiences of daily living; Part 3: Motor examination; Part 4: Motor complications. Part 4 raters use historical/objective information to assess 2 motor complications, dyskinesias and motor fluctuations including OFF-state dystonia. Raters use information from participant, caregiver, and the examination to answer 6 questions. The duration of disability caused and functional impact of any dyskinesias experienced by the participant were rated on a scale of 0 to 4. 6 items being performed on scale from 0 (normal) to 4 (severe), where the total score ranged from 0 to 24, lower score indicated better motor function and higher score indicated more severe motor symptoms."}, {'measure': "Change From Baseline in King's Parkinson's Disease Pain Scale (KPPS) at Week 18", 'timeFrame': 'Baseline, Week 18', 'description': "KPPS is a Parkinson's Disease-specific pain scale that evaluated the localization, frequency, and intensity of pain. It has 14 items in 7 domains: 1. Musculoskeletal pain; 2. Chronic pain; 3. Fluctuation-related pain; 4. Nocturnal pain; 5. Oro-facial pain; 6. Discoloration, Oedema/Swelling pain; 7. Radicular pain. Each item was scored by severity (0 \\[none\\] to 3 \\[very severe\\]) multiplied by frequency (0 \\[never\\] to 4 \\[all the time\\]), resulting in a subscore of 0 to 12, the sum of which gives the total score which ranged from 0 to 168. Higher scores indicated more severity and frequency of pain."}, {'measure': 'Change From Baseline in Mini-Mental State Examination (MMSE) at Week 18', 'timeFrame': 'Baseline, Week 18', 'description': 'The MMSE is a brief practical screening test for cognitive dysfunction. The test consists of 5 sections (orientation, registration, attention and calculation, recall, and language) and has a total possible score of 30. Total scores ranged from 0 (most impaired) to 30 (no impairment). MMSE used to assess the severity of cognitive dysfunction, with a higher score indicating better cognitive state.'}, {'measure': 'Change From Baseline in Daily "ON" Time Without Dyskinesia at Week 18', 'timeFrame': 'Baseline, Week 18', 'description': 'Participants received diary card and information on daily \'off\' time and \'on\' time was collected. At 30-minute intervals throughout the period, the participant/caregiver recorded whether the participant was in an "on" phase, 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 "on" time was defined as the sum of the time without dyskinesia during the on phase to number of days completed in the diary.'}, {'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)', 'description': 'A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. SAE was any untoward medical occurrence that at any dose: results in death, was life-threatening, inpatient hospitalization, requires prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), was a medically significant event.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '39540934', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, age greater than or equal to (\\>=) 19 years at the time of informed consent\n2. 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\n3. Parkinson\'s Disease participants who are receiving levodopa without Catechol O-methyltransferase (COMT) inhibitor and/or Monoamine oxidase-B (MAO-B) inhibitor\n4. 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\n5. Be able to provide written informed consent\n6. 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)\n\nExclusion Criteria:\n\n1. Females who are planning for pregnancy, pregnant or breastfeeding\n2. Prior use of safinamide\n3. 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)\n4. Use of medications for depression or psychosis within 5 weeks prior to screening\n5. History of allergic response to levodopa, or other anti-Parkinsonian agents\n6. Hypersensitivity or contraindications to MAO-B inhibitors\n7. 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\n8. 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)\n9. 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\n10. Administering central nervous system stimulants (example, methylphenidate hydrochloride, lisdexamfetamine mesilate)\n11. Administering dextromethorphan\n12. 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\n13. Have a history of hypersensitivity to any of the ingredients of the product\n14. 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'}, 'identificationModule': {'nctId': 'NCT05312632', 'briefTitle': "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", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'ME2125-M082-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safinamide Mesilate', 'description': "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.", 'interventionNames': ['Drug: Safinamide Mesilate']}], 'interventions': [{'name': 'Safinamide Mesilate', 'type': 'DRUG', 'otherNames': ['Equfina', 'ME2125'], 'description': 'Safinamide Mesilate oral tablets.', 'armGroupLabels': ['Safinamide Mesilate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Eisai Site #11', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Eisai Site #20', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Eisai Site #3', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Eisai Site #16', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Eisai Site #2', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Eisai Site #19', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Eisai Site #10', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Eisai Site #12', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Eisai Site #15', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Eisai Site #17', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Eisai Site #5', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Eisai Site #14', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Site #13', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Site #18', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Site #1', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Site #4', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Site #6', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Site #7', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Site #8', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eisai Site #9', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Korea Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}