A Phase 4 interventional study of Safinamide Mesilate in Parkinson Disease, sponsored by Eisai Korea Inc.. Completed at 20 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Eisai Korea Inc. (part of Eisai Co., Ltd.) · Phase 4, Interventional, and Treatment
Among 17 studies testing safinamide in Parkinson Disease — 1 open to participants now, 1 under way, 1 of them phase 3. safinamide · Parkinson Disease.
Among the 17 studies testing safinamide in Parkinson Disease, this one is the 8th largest by enrollment, is the only one that started in 2022, is one of 4 in phase 4, and was the 16th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →1 of the 17 studies testing safinamide in Parkinson Disease is open now, in 1 country. Recruiting first, the newest first:
Universita di Verona · Sites in Italy
Ages 18+
By country, each count listing its studies:
safinamide: first FDA approval 2017 (XADAGO), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 9 · Phase 4 4
First in 2004; this study’s year is marked. 1 started in 2022.
This study's enrollment of 201 is above the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 103 across the 17 interventional studies. Of the 15 that completed or were terminated, 3 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 17 have an industry lead sponsor. The 6 most frequent:
This study is registered under Eisai Korea Inc., one of the names counted as Eisai Co., Ltd.. Under that name alone:
Eisai Korea Inc. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
18 studies in Parkinson Disease by Eisai Co., Ltd.: none open now, none under way, none of them phase 3. Of 17 finished, 10 (59%) have results posted.
Among the 18 studies in Parkinson Disease by Eisai Co., Ltd., this one is the 7th largest by enrollment of the 15 interventional ones that give a count, is the only one that started in 2022, is the only one in phase 4, and was the 18th registered.
Eisai Co., Ltd.’s Parkinson Disease studies by the year they started, since 2002.
None of the studies under way reaches primary completion within a year.
Among the 17 studies testing safinamide in Parkinson Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Eisai Co., Ltd.’s 18 in Parkinson Disease:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Safinamide Mesilate oral tablets.
Also known as: Equfina, ME2125
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.
Time frame: 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.
Time frame: Baseline, Week 18
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating (MDS-UPDRS) Part 3 at Week 18
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.
Time frame: Baseline, Week 18
Change From Baseline in MDS-UPDRS Part 4 at Week 18
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.
Time frame: Baseline, Week 18
Change From Baseline in King's Parkinson's Disease Pain Scale (KPPS) at Week 18
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.
Time frame: Baseline, Week 18
Change From Baseline in Mini-Mental State Examination (MMSE) at Week 18
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.
Time frame: Baseline, Week 18
Change From Baseline in Daily "ON" Time Without Dyskinesia at Week 18
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.
Time frame: Baseline, Week 18
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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.
Time frame: From the first dose of the study drug up to end of the treatment (up to Week 18)
Participants took part in the study at 20 investigative sites in South Korea from 05 April 2022 to 25 May 2023.
| Milestone | Safinamide Mesilate 100 mg |
|---|---|
| Started | 201 |
| Safety analysis population | 199 |
| Full analysis population | 196 |
| Completed | 162 |
| Not completed | 39 |
| Withdrew: Adverse event | 12 |
| Withdrew: Withdrawal by subject | 10 |
| Withdrew: Lack of efficacy | 4 |
| Withdrew: Non-compliance with study procedures | 9 |
| Withdrew: Other | 4 |
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.
| hours | Safinamide Mesilate 100 mg |
|---|---|
| Change From Baseline in Daily "OFF" Time at Week 18 | -0.8 (-11.2 to 3.7) |
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.
| score on a scale | Safinamide Mesilate 100 mg |
|---|---|
| Change From Baseline in PDQ-39 Score at Week 18 | -2.7 ± 10.3 |
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.
| score on a scale | Safinamide Mesilate 100 mg |
|---|---|
| Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating (MDS-UPDRS) Part 3 at Week 18 | -1.7 ± 8.4 |
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.
| score on a scale | Safinamide Mesilate 100 mg |
|---|---|
| Change From Baseline in MDS-UPDRS Part 4 at Week 18 | -0.7 ± 2.1 |
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.
| score on a scale | Safinamide Mesilate 100 mg |
|---|---|
| Change From Baseline in King's Parkinson's Disease Pain Scale (KPPS) at Week 18 | -1.5 ± 11.3 |
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.
| score on a scale | Safinamide Mesilate 100 mg |
|---|---|
| Change From Baseline in Mini-Mental State Examination (MMSE) at Week 18 | 0.2 ± 1.7 |
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.
| hours | Safinamide Mesilate 100 mg |
|---|---|
| Change From Baseline in Daily "ON" Time Without Dyskinesia at Week 18 | 0.7 (-6.2 to 10.0) |
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.
| Participants | Safinamide Mesilate 100 mg |
|---|---|
| TEAEs | 80 |
| SAEs | 4 |
Collected over From the first dose of the study drug up to end of the treatment (up to Week 18). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safinamide Mesilate 100 mg | 0/199 (0%) | 4/199 (2%) | 56/199 (28.1%) |
| Event | Safinamide Mesilate 100 mg |
|---|---|
| Cartilage injuryInjury, poisoning and procedural complications | 1/199 |
| Muscle ruptureInjury, poisoning and procedural complications | 1/199 |
| Skin lacerationInjury, poisoning and procedural complications | 1/199 |
| Condition aggravatedGeneral disorders | 1/199 |
| COVID-19Infections and infestations | 1/199 |
| Event | Safinamide Mesilate 100 mg |
|---|---|
| OverdoseInjury, poisoning and procedural complications | 13/199 |
| DyskinesiaNervous system disorders | 11/199 |
| DizzinessNervous system disorders | 5/199 |
| NauseaGastrointestinal disorders | 5/199 |
| COVID-19Infections and infestations | 5/199 |
| Drug ineffectiveGeneral disorders | 4/199 |
| Decreased appetiteMetabolism and nutrition disorders | 4/199 |
| TremorNervous system disorders | 3/199 |
| ConstipationGastrointestinal disorders | 3/199 |
| DystoniaNervous system disorders | 2/199 |
The safety analysis population included participants who received at least 1 dose of study drug and completed at least 1 post-dose safety assessment.
| Age, Continuous(years) | Safinamide Mesilate 100 mg |
|---|---|
| Mean | 63.6 ± 7.8 |
| Sex: Female, Male(Participants) | Safinamide Mesilate 100 mg |
|---|---|
| Female | 104 |
| Male | 95 |
| Race/Ethnicity, Customized(Participants) | Safinamide Mesilate 100 mg |
|---|---|
| Asian | 199 |
| Race/Ethnicity, Customized(Participants) | Safinamide Mesilate 100 mg |
|---|---|
| Not Hispanic or Latino | 199 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Ran from Apr 2022 to primary completion in May 2023, 13 months.
Results were first posted in Sep 2024, 1 year 3 months after primary completion.
Of 56 phase 4 interventional studies under Parkinson Disease, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 65. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Safinamide