A Phase 3 interventional study of Safinamide and Placebo in Parkinson Disease, sponsored by Zambon SpA. Completed at 31 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Zambon SpA · Phase 3, Interventional, and Treatment
This is a Phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the effects of 100 mg safinamide, administered orally once daily (OD), in Chinese Parkinson's disease (PD) patients, experiencing motor fluctuations while on stable doses of Levodopa (L-dopa) (alone or in combination with other anti-Parkinson drugs). Eligible patients are required to meet the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria. The study involves a placebo group. Placebo will be added to the standard stabilized treatment as a control of the safinamide group, hence patients on placebo will have benefit from other ongoing anti-PD medication. A total of 306 patients will be randomised into this study (153 in the safinamide and 153 in the placebo groups).
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 307 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Zambon SpA is the lead sponsor of 23 studies on the registry; none are open to participants now.
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If female, be post-menopausal for at least one year or have undergone hysterectomy or, if of child-bearing potential, must have a negative pregnancy test, must not be breast-feeding nor become pregnant during the study and must use adequate contraception for 1 month prior to randomisation and for up to 1 month after the last dose of study drug. Adequate contraception is defined as:
For all women of child-bearing potential, urine pregnancy test result at screening must be negative.
Exclusion Criteria:
Patient will receive film-coated Safinamide tablets orally at an initial dose of 50 mg once daily (OD) and then will be increased the day after the Visit 3/week 2 (ideally at day 15) to the final dose of 100 mg OD. Treatment will continue daily for a total of 16 weeks.
Drug: Safinamide
Patient will receive matching placebo orally at an initial dose of 50 mg once daily (OD) and then will be increased the day after the Visit 3/week 2 (ideally at day 15) to the final dose of 100 mg OD. Treatment will continue daily for a total of 16 weeks.
Other: Placebo
At baseline (Day 1), eligible patients will be randomised to receive safinamide (initial 50 mg titrated to 100 mg the day after the Visit 3/week 2, ideally at day 15). The investigational medicinal product (IMP) will be taken in the morning at breakfast time, in addition to the morning dose of L-dopa and other (if any) PD medications.
At baseline (Day 1), eligible patients will be randomised to receive matching placebo, orally OD. Placebo will be added to the standard stabilized treatment as a control of the safinamide group, hence patients on placebo will have benefit from other ongoing anti-PD medication
Change From Baseline to Week 16 in the Mean Total Daily "OFF" Time
The mean total daily "OFF" time was assessed by 24-hour patient diary cards, of safinamide 100 mg/day compared to placebo, given as add-on therapy in PD patients with motor fluctuations on stable doses of L-dopa. Patients completed the daily diary by selecting one of the following five options for each 30-minute time period: * "OFF" (Stiffness, marked decrease in mobility, or immobility). * "ON" without dyskinesia (Good or practically normal mobility without dyskinesia). * "ON" with non-troublesome dyskinesia (With dyskinesia but it does not interfere with function/cause meaningful discomfort). * "ON" with troublesome dyskinesia (With dyskinesia which interferes with function/causes meaningful discomfort. Of note, these dyskinesia movements are different from the rhythmic "tremor" (a symptom of Parkinson's Disease itself). * Asleep (Time spent asleep).
Time frame: At baseline and Week 16
Change From Baseline to Week 16 in Pain Severity, as Assessed by an 11 Point Numerical Rating Scale (NRS)
The pain severity, was assessed by an 11-point Numerical Rating Scale (NRS). The NRS is a segmented numeric version of the visual analogue scale (VAS) in which a patient selects a whole number that best reflects the intensity of his/her pain, ranging from '0' ("no pain") to '10' ("worst possible pain").
Time frame: At baseline and Week 16
Change From Baseline to Week 16 in the Mean Total Daily "ON" Time
The mean total daily "ON" time, as assessed by 24-hour patient diary cards. Patients completed the daily diary by selecting one of the following five options for each 30-minute time period: * "OFF" (Stiffness, marked decrease in mobility, or immobility). * "ON" without dyskinesia (Good or practically normal mobility without dyskinesia). * "ON" with non-troublesome dyskinesia (With dyskinesia but it does not interfere with function/cause meaningful discomfort). * "ON" with troublesome dyskinesia (With dyskinesia which interferes with function/causes meaningful discomfort. Of note, these dyskinesia movements are different from the rhythmic "tremor" (a symptom of Parkinson's Disease itself). * Asleep (Time spent asleep).
Time frame: At baseline and Week 16
Change From Baseline to Week 16 in the Mean Daily "ON" Time With no/Non Troublesome Dyskinesia
The mean daily "ON" time with no/non troublesome dyskinesia, as assessed by 24-hour patient diary cards. Patients completed the daily diary by selecting one of the following five options for each 30-minute time period: * "OFF" (Stiffness, marked decrease in mobility, or immobility). * "ON" without dyskinesia (Good or practically normal mobility without dyskinesia). * "ON" with non-troublesome dyskinesia (With dyskinesia but it does not interfere with function/cause meaningful discomfort). * "ON" with troublesome dyskinesia (With dyskinesia which interferes with function/causes meaningful discomfort. Of note, these dyskinesia movements are different from the rhythmic "tremor" (a symptom of Parkinson's Disease itself). * Asleep (Time spent asleep).
Time frame: At baseline and Week 16
Change From Baseline to Week 16 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score During the "ON" Phase
The UPDRS comprises 3 parts that evaluates any complication of treatment: Part I: Evaluation of mentation or cognition, behavior and mood. Part II: Evaluation of the activities of daily life. Part III: Evaluation of motor function. Part IV: Evaluation of complications of therapy. The UPDRS performed by the Investigator with points assigned to each item in the scale based on the patient's response as well as observation and physical examination. Together Parts I-III contain 44 items, with each item scored on a 5-point scale. Part IV contains 11 questions with a scale ranging from 0 to 23. Thus, the final total score may range from 0 (no disability) to 199 (total disability). The UPDRS is the most commonly used scale in clinical studies to follow the longitudinal course of PD. Part I Evaluation of mentation or cognition, behavior and mood contains 4 items with each item scored on a 5 point scale, the scale ranging from 0 to 16.
Time frame: At baseline and Week 16
Change From Baseline to Week 16 in the UPDRS Part II Activities of Daily Living (ADL) Score During the "ON" Phase
The UPDRS= Unified Parkinson's Disease Rating Scale; is the most commonly used scale in clinical studies to follow the longitudinal course of PD. It is divided in 4 sections, each of them with several items. The score of each item is 0-1 or 0-4 (the majority) where 0 is no symptom while the highest score means the most severe symptom. UPDRS part I: 4 items, score 0-16 (total); UPDRS part II: 13 items, score 0-52 (total); UPDRS part III: 14 items, score 0-108 (total) UPDRS part IV: it is dived in 3 sections. Section A=dyskinesias, 4 items, score 0-13 (total); section B=clinical fluctuations, 4 items, score 0-7 (total); section C=other complications, 3 items, score 0-3 (total). The total score of the UPDRS (meaning of all the 4 parts) is 0-199 where 0 means no symptoms, 199 the most severe symptoms.
Time frame: At baseline and Week 16
Change From Baseline to Week 16 in the UPDRS Part III (Motor Function) Score During the "ON" Phase
The UPDRS= Unified Parkinson's Disease Rating Scale; is the most commonly used scale in clinical studies to follow the longitudinal course of PD. It is divided in 4 sections, each of them with several items. The score of each item is 0-1 or 0-4 (the majority) where 0 is no symptom while the highest score means the most severe symptom. UPDRS part I: 4 items, score 0-16 (total); UPDRS part II: 13 items, score 0-52 (total); UPDRS part III: 14 items, score 0-108 (total) UPDRS part IV: it is dived in 3 sections. Section A=dyskinesias, 4 items, score 0-13 (total); section B=clinical fluctuations, 4 items, score 0-7 (total); section C=other complications, 3 items, score 0-3 (total). The total score of the UPDRS (meaning of all the 4 parts) is 0-199 where 0 means no symptoms, 199 the most severe symptoms.
Time frame: At baseline and Week 16
Clinical Global Impression of Severity (CGI-S) Score Assessed at Week 16
The CGI-S scale measures global severity of illness at a given point in time. It is rated on a 7-point Likert-type scale ranging from 1 (normal, not ill at all) to 7 (extremely severe). The CGI-S was assessed at all visits, starting at baseline.
Time frame: At week 16
Clinical Global Impression of Change (CGI-C) Assessed at Week 16
The CGI-C scale measured the change in the patient's clinical status from baseline using a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change. The change from the patient's baseline condition is assessed by the Investigator at all post-baseline visits.
Time frame: At baseline and Week 16
Change From Baseline to Week 16 in the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Score
The PDQ-39 comprises 39 questions measuring eight dimensions of health: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily pain. Dimension scores are coded on a scale of 0 (perfect health as assessed by the measure) to 100 (worst health as assessed by the measure).
Time frame: At baseline and Week 16
Number of Patients With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Event (TESAE)
Evaluation of the safety and tolerability of safinamide compared with placebo in Chinese PD patients with motor fluctuations.
Time frame: From baseline until follow-up visit (1 Week after the end of treatment [Up to 2 Years])
A total of 307 patients were randomized at approximately 31 study centres in China between 01-Aug-2019 to 20-Aug-2021.
| Milestone | Safinamide | Placebo |
|---|---|---|
| Started | 153 | 154 |
| Number treated | 151 | 154 |
| Completed | 137 | 130 |
| Not completed | 16 | 24 |
| Withdrew: Adverse event | 8 | 9 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Non-compliance with study drug | 0 | 2 |
| Withdrew: Physician decision | 3 | 3 |
| Withdrew: Withdrawal by subject | 2 | 10 |
| Withdrew: Discontinuation from study | 1 | 0 |
The mean total daily "OFF" time was assessed by 24-hour patient diary cards, of safinamide 100 mg/day compared to placebo, given as add-on therapy in PD patients with motor fluctuations on stable doses of L-dopa. Patients completed the daily diary by selecting one of the following five options for each 30-minute time period: * "OFF" (Stiffness, marked decrease in mobility, or immobility). * "ON" without dyskinesia (Good or practically normal mobility without dyskinesia). * "ON" with non-troublesome dyskinesia (With dyskinesia but it does not interfere with function/cause meaningful discomfort). * "ON" with troublesome dyskinesia (With dyskinesia which interferes with function/causes meaningful discomfort. Of note, these dyskinesia movements are different from the rhythmic "tremor" (a symptom of Parkinson's Disease itself). * Asleep (Time spent asleep).
| Hours | Safinamide | Placebo |
|---|---|---|
| Change From Baseline to Week 16 in the Mean Total Daily "OFF" Time | -1.93 ± 2.556 | -0.88 ± 2.543 |
The pain severity, was assessed by an 11-point Numerical Rating Scale (NRS). The NRS is a segmented numeric version of the visual analogue scale (VAS) in which a patient selects a whole number that best reflects the intensity of his/her pain, ranging from '0' ("no pain") to '10' ("worst possible pain").
| Score on a Scale | Safinamide | Placebo |
|---|---|---|
| Change From Baseline to Week 16 in Pain Severity, as Assessed by an 11 Point Numerical Rating Scale (NRS) | -0.0 ± 1.89 | -0.0 ± 2.14 |
The mean total daily "ON" time, as assessed by 24-hour patient diary cards. Patients completed the daily diary by selecting one of the following five options for each 30-minute time period: * "OFF" (Stiffness, marked decrease in mobility, or immobility). * "ON" without dyskinesia (Good or practically normal mobility without dyskinesia). * "ON" with non-troublesome dyskinesia (With dyskinesia but it does not interfere with function/cause meaningful discomfort). * "ON" with troublesome dyskinesia (With dyskinesia which interferes with function/causes meaningful discomfort. Of note, these dyskinesia movements are different from the rhythmic "tremor" (a symptom of Parkinson's Disease itself). * Asleep (Time spent asleep).
| Hours | Safinamide | Placebo |
|---|---|---|
| Change From Baseline to Week 16 in the Mean Total Daily "ON" Time | 1.30 ± 2.693 | 0.51 ± 2.875 |
The mean daily "ON" time with no/non troublesome dyskinesia, as assessed by 24-hour patient diary cards. Patients completed the daily diary by selecting one of the following five options for each 30-minute time period: * "OFF" (Stiffness, marked decrease in mobility, or immobility). * "ON" without dyskinesia (Good or practically normal mobility without dyskinesia). * "ON" with non-troublesome dyskinesia (With dyskinesia but it does not interfere with function/cause meaningful discomfort). * "ON" with troublesome dyskinesia (With dyskinesia which interferes with function/causes meaningful discomfort. Of note, these dyskinesia movements are different from the rhythmic "tremor" (a symptom of Parkinson's Disease itself). * Asleep (Time spent asleep).
| Hours | Safinamide | Placebo |
|---|---|---|
| Change From Baseline to Week 16 in the Mean Daily "ON" Time With no/Non Troublesome Dyskinesia | 1.30 ± 2.927 | 0.39 ± 3.212 |
The UPDRS comprises 3 parts that evaluates any complication of treatment: Part I: Evaluation of mentation or cognition, behavior and mood. Part II: Evaluation of the activities of daily life. Part III: Evaluation of motor function. Part IV: Evaluation of complications of therapy. The UPDRS performed by the Investigator with points assigned to each item in the scale based on the patient's response as well as observation and physical examination. Together Parts I-III contain 44 items, with each item scored on a 5-point scale. Part IV contains 11 questions with a scale ranging from 0 to 23. Thus, the final total score may range from 0 (no disability) to 199 (total disability). The UPDRS is the most commonly used scale in clinical studies to follow the longitudinal course of PD. Part I Evaluation of mentation or cognition, behavior and mood contains 4 items with each item scored on a 5 point scale, the scale ranging from 0 to 16.
| Change in score | Safinamide | Placebo |
|---|---|---|
| Change From Baseline to Week 16 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score During the "ON" Phase | -12.3 ± 13.59 | -5.8 ± 12.30 |
The UPDRS= Unified Parkinson's Disease Rating Scale; is the most commonly used scale in clinical studies to follow the longitudinal course of PD. It is divided in 4 sections, each of them with several items. The score of each item is 0-1 or 0-4 (the majority) where 0 is no symptom while the highest score means the most severe symptom. UPDRS part I: 4 items, score 0-16 (total); UPDRS part II: 13 items, score 0-52 (total); UPDRS part III: 14 items, score 0-108 (total) UPDRS part IV: it is dived in 3 sections. Section A=dyskinesias, 4 items, score 0-13 (total); section B=clinical fluctuations, 4 items, score 0-7 (total); section C=other complications, 3 items, score 0-3 (total). The total score of the UPDRS (meaning of all the 4 parts) is 0-199 where 0 means no symptoms, 199 the most severe symptoms.
| Change in score | Safinamide | Placebo |
|---|---|---|
| Change From Baseline to Week 16 in the UPDRS Part II Activities of Daily Living (ADL) Score During the "ON" Phase | -2.7 ± 4.45 | -1.2 ± 4.32 |
The UPDRS= Unified Parkinson's Disease Rating Scale; is the most commonly used scale in clinical studies to follow the longitudinal course of PD. It is divided in 4 sections, each of them with several items. The score of each item is 0-1 or 0-4 (the majority) where 0 is no symptom while the highest score means the most severe symptom. UPDRS part I: 4 items, score 0-16 (total); UPDRS part II: 13 items, score 0-52 (total); UPDRS part III: 14 items, score 0-108 (total) UPDRS part IV: it is dived in 3 sections. Section A=dyskinesias, 4 items, score 0-13 (total); section B=clinical fluctuations, 4 items, score 0-7 (total); section C=other complications, 3 items, score 0-3 (total). The total score of the UPDRS (meaning of all the 4 parts) is 0-199 where 0 means no symptoms, 199 the most severe symptoms.
| Change in score | Safinamide | Placebo |
|---|---|---|
| Change From Baseline to Week 16 in the UPDRS Part III (Motor Function) Score During the "ON" Phase | -8.2 ± 9.64 | -3.7 ± 8.71 |
The CGI-S scale measures global severity of illness at a given point in time. It is rated on a 7-point Likert-type scale ranging from 1 (normal, not ill at all) to 7 (extremely severe). The CGI-S was assessed at all visits, starting at baseline.
| Point on scale | Safinamide | Placebo |
|---|---|---|
| Clinical Global Impression of Severity (CGI-S) Score Assessed at Week 16 | 3.6 ± 0.80 | 3.8 ± 0.95 |
The CGI-C scale measured the change in the patient's clinical status from baseline using a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change. The change from the patient's baseline condition is assessed by the Investigator at all post-baseline visits.
| Point on scale | Safinamide | Placebo |
|---|---|---|
| Clinical Global Impression of Change (CGI-C) Assessed at Week 16 | 3.0 ± 1.12 | 3.4 ± 1.03 |
The PDQ-39 comprises 39 questions measuring eight dimensions of health: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily pain. Dimension scores are coded on a scale of 0 (perfect health as assessed by the measure) to 100 (worst health as assessed by the measure).
| Change in score | Safinamide | Placebo |
|---|---|---|
| Change From Baseline to Week 16 in the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Score | -6.42 ± 10.223 | -2.67 ± 10.901 |
Evaluation of the safety and tolerability of safinamide compared with placebo in Chinese PD patients with motor fluctuations.
| Participants | Safinamide | Placebo |
|---|---|---|
| Any TEAE | 105 | 88 |
| Any TEAE Related to study drug | 54 | 40 |
| Any Severe TEAE | 4 | 4 |
| Any Severe TEAE, Related to study drug | 3 | 1 |
| Any TEAE with Outcome of Death | 1 | 0 |
| Any TEAE with Outcome of Death to study drug | 1 | 0 |
| Any TESAE | 8 | 5 |
| Any TESAE, Related to Study Drug | 4 | 3 |
| Any TEAE Leading to Study Withdrawal | 8 | 9 |
| Any TEAE Leading to Discontinuation of Study Drug | 8 | 10 |
| Any TESAE Leading to Study Withdrawal | 3 | 1 |
| Any TESAE Leading to Discontinuation of Study Drug | 3 | 1 |
| Any TEAE Leading to Discontinuation of Study Drug | 7 | 10 |
| Any TEAE Leading to Dose Reduction of Study Drug | 7 | 2 |
Collected over From baseline until follow-up visit (1 Week after the end of treatment [Up to 2 Years]). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safinamide | 1/151 (0.7%) | 8/151 (5.3%) | 42/151 (27.8%) |
| Placebo | 0/154 (0%) | 5/154 (3.2%) | 35/154 (22.7%) |
| Event | Safinamide | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 1/151 | 0/154 |
| Vascular headacheNervous system disorders | 1/151 | 0/154 |
| Ventricular extrasystolesCardiac disorders | 1/151 | 1/154 |
| HaemorrhoidsGastrointestinal disorders | 1/151 | 0/154 |
| Chest discomfortGeneral disorders | 1/151 | 0/154 |
| Completed suicidePsychiatric disorders | 1/151 | 0/154 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/151 | 0/154 |
| HypertensionVascular disorders | 1/151 | 0/154 |
| Parkinson's diseaseNervous system disorders | 0/151 | 1/154 |
| Angina unstableCardiac disorders | 0/151 | 1/154 |
| Event | Safinamide | Placebo |
|---|---|---|
| DyskinesiaNervous system disorders | 18/151 | 6/154 |
| Parkinson's diseaseNervous system disorders | 7/151 | 14/154 |
| DizzinessNervous system disorders | 9/151 | 10/154 |
| Back painMusculoskeletal and connective tissue disorders | 9/151 | 6/154 |
| ConstipationGastrointestinal disorders | 6/151 | 8/154 |
Safety population were included all patients who provided informed consent and received at least 1 dose or partial dose of study drug.
| Age, Continuous(Years) | Safinamide | Placebo | Total |
|---|---|---|---|
| Mean | 61.4 ± 9.29 | 61.8 ± 9.28 | 61.6 ± 9.27 |
| Sex: Female, Male(Participants) | Safinamide | Placebo | Total |
|---|---|---|---|
| Female | 59 | 69 | 128 |
| Male | 92 | 85 | 177 |
| Race/Ethnicity, Customized(Participants) | Safinamide | Placebo | Total |
|---|---|---|---|
| Chinese | 151 | 154 | 305 |
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Zambon SpA