Parkinson DiseasePhase 3NCT03881371
A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa
A Phase 3 study testing Safinamide in people with Parkinson Disease, run by Zambon SpA at 31 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Safinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 307 participants
- Where
- 31 sitesChina
- Study dates
- 1 Aug 2019to 20 Aug 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years old.
- Chinese ethnicity.
- Able to understand and willing to provide written informed consent.
- Able to maintain an accurate and complete 24-hour diary with the help of a caregiver.
- Diagnosis of idiopathic Parkinson's Disease (IPD) using the United Kingdom Parkinson's Disease Society Brain Bank criteria of more than 3 years duration.
- Be levodopa responsive and receiving treatment with stable daily doses of oral L-dopa, with or without benserazide/carbidopa, with or without addition of a catechol-O-methyltransferase (COMT) inhibitor and may be receiving concomitant treatment with stable doses of dopamine agonists, anticholinergics and/or amantadine for at least 4 weeks prior to the screening visit.
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- A Hoehn and Yahr stage between 1-4 inclusive during the "ON" phase.
- Experiencing motor fluctuations with a minimum of 1.5 hours/day of "OFF" time during the day (excluding morning akinesia), based on historical data.
- 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:
- Hormonal oral, implantable, transdermal, or injectable contraceptives or a non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit;
- a male sexual partner who agrees to use a male condom with spermicide or a sterile sexual partner . For all women of child-bearing potential, urine pregnancy test result at screening must be negative.
- For all women of child-bearing potential, urine pregnancy test result at screening must be negative.
Who cannot join
- Any form of Parkinsonism other than IPD.
- Diagnosis of chronic migraine (>15 days per month) or cancer pain.
- L-dopa infusion.
- Hoehn and Yahr stage 5 during the "ON" phase.
- If female, pregnancy or breast-feeding.
- Neurosurgical intervention of PD or stereotactic brain surgery.
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- Severe peak dose or biphasic dyskinesia, unpredictable or widely swinging fluctuations.
- History of major depression or other clinically significant psychotic disorder which compromise the ability to provide the informed consent or to participate to the study.
- Drug and/or alcohol abuse within 12 months prior to the screening visit.
- History of dementia or severe cognitive dysfunction.
- Use of any investigational drug or device within 30 days prior to screening or 5 half-lives, whichever is the longest, or during the study.
- Allergy/sensitivity or contraindications to the investigational medicinal products (IMPs) or their excipients, to anticonvulsants or to anti-Parkinson drugs.
- Any clinically significant condition (including laboratory values) which, in the opinion of the Investigator, would not be compatible with study participation or represent a risk for patients while in the study.
- Moderate or severe liver failure using the Child-Pugh classification score, or human immunodeficiency virus (HIV) infection.
- Treatment with monoamine oxidase inhibitors (MAOIs), pethidine, opiates, opioids, fluoxetine, fluvoxamine in the 4 weeks prior to the screening visit. These drugs are not allowed throughout the study and up 2 weeks after the last dose of study drug.
- Ophthalmologic history including any of the following conditions: albinism, uveitis, retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive diabetic retinopathy, inherited retinopathy or family history of hereditary retinal disease.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
China31 sites
The First Affiliated Hospital of Baotou Medical University 内蒙古科技大学包头医学院第一附属医院
Baotou, No.41 Linyin Road
Baotou City Central Hospital 包头市中心医院
Baotou, No.61, Huancheng Road, Donghe District
Beijing Friendship Hospital 首都医科大学附属北京友谊医院
Beijing, No. 6, Tiantan XI Li, Chongwen District
Beijing Tiantan Hospital Affiliated to Capital Medical University 首都医科大学附属北京天坛医院
Beijing, No. 6, Tiantan XI Li, Chongwen District
The First Bethune Hospital of Jilin University
Changchun, No. 71, Xin Min Street
The Third Xiangya Hospital of Central South University 中南大学湘雅三医院
Changsha, No. 138, Tong Zi Po Road, He XI Yue Lu District
Sichuan Provincial People's Hospital 四川省医学科学院·四川省人民医院
Chengdu, No. 32 XI Er Duan, First Ring Road, Qing Yang District
West China Hospital, Sichuan University 四川大学华西医院
Chengdu, No. 37, Guoxue Alley
Chongqing Three Gorges Central Hospital 重庆三峡中心医院
Chongqing, No.165 Xincheng Rd, Wanzhou District
Daqing Oilfield General Hospital 大庆油田总医院
Daqing
Fujian Medical University Union Hospital 福建医科大学附属协和医院
Fuzhou
Guangzhou First People's Hospital 广州市第一人民医院
Guangzhou, No.1 Panfu Rd.
Sun Yat-sen Memorial Hospital 中山大学孙逸仙纪念医院
Guangzhou, No.107, Yanjiang West Road
The First Affiliated Hospital of Guangzhou Medical University 广州医科大学附属第一医院
Guangzhou, Number 151, Yanjiang Road
The Affiliated Hospital Of Guiyang Medical College 贵州医科大学附属医院
Guiyang, No28. Guiyi Street
Sir Run Run Shaw Hospital, Zhejiang University 浙江大学医学院附属邵逸夫医院
Hangzhou, No 3, Qing Chun East Road
The Second Affiliated Hospital of Zhejiang University 浙江大学医学院附属第二医院
Hangzhou, No. 88, Jie Fang Rd.
Qilu Hospital of Shandong University 山东大学齐鲁医院
Jinan
The Second Affiliated Hospital of Nanchang University 南昌大学第二附属医院
Nanchang, No.1 Minde Road of Nanchang
Nanjing Drum Tower Hospital 南京鼓楼医院
Nanjing
Shanghai Ninth People's Hospital 上海交通大学医学院附属第九人民医院
Shanghai, No 639, Zhizaoju Road
Shanghai General Hospital 上海市第一人民医院
Shanghai, No.100 Haining Road
Shanghai Ruijin Hospital 上海交通大学医学院附属瑞金医院
Shanghai, No.197 Ruijin Er Road
The Third Hospital of Hebei Medical University 河北医科大学第三医院
Shijiazhuang, No.139.Zi Qiang Rd
The second affiliated hospital of Soochow University 苏州大学附属第二医院
Suzhou
The First Hospital of Shanxi Medical University 山西医科大学第一医院
Taiyuan, No. 85, Jie Fang South Road
Tianjin Union Medicine Center 天津市人民医院
Tianjin, No. 130, Jie Yuan Rd., Hong Qiao District
Wenzhou Medical College-The First Affiliated Hospital 温州医科大学附属第一医院
Wenzhou, Shangcai Burg, Ouhai District
Renmin Hospital of Wuhan University 武汉大学人民医院
Wuhan, No. 238, Jie Fang Road
Tongji Hospital of Tongji University 同济大学附属同济医院
Wuhan, No.1095 Jiefang Avenue
The Affiliated Hospital of Xuzhou Medical University 徐州医科大学附属医院
Xuzhou, No.99, Huaihai West Road, Xuzhou, Jiangsu
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa
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).
- Conditions
- Parkinson Disease
- Being tested
- Safinamide, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafinamideDrug
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.
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| Safinamide | Experimental | 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. Receives: Drug: Safinamide |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline and Week 16
Secondary outcomes (9)
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").
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Aug 2019
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zambon SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881371
- Sponsor's protocol ID
- Z7219L05
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2019
- Last updated
- 20 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dei Cas A, Micheli MM, Aldigeri R, Gardini S, Ferrari-Pellegrini F, Perini M, Messa G, Antonini M, Spigoni V, Cinquegrani G, Vazzana A, Moretti V, Caffarra P, Bonadonna RC. Long-acting exenatide does not prevent cognitive decline in mild cognitive impairment: a proof-of-concept clinical trial. J Endocrinol Invest. 2024 Sep;47(9):2339-2349. doi: 10.1007/s40618-024-02320-7. Epub 2024 Apr 2.
PubMed 38565814Cattaneo C, Kulisevsky J. The Effects of Safinamide in Chinese and Non-Chinese Patients with Parkinson's Disease. Adv Ther. 2024 Feb;41(2):638-648. doi: 10.1007/s12325-023-02736-2. Epub 2023 Dec 9.
PubMed 38070039Wei Q, Tan Y, Xu P, Tao E, Lu Z, Pan X, Wang B, Liu C, Dong X, Tian Y, Sun X, Cattaneo C, Chen S, Shang H; XINDI Study Investigators Group. The XINDI Study: A Randomized Phase III Clinical Trial Evaluating the Efficacy and Safety of Safinamide as Add-On Therapy to Levodopa in Chinese Patients with Parkinson's Disease with Motor Fluctuations. CNS Drugs. 2022 Nov;36(11):1217-1227. doi: 10.1007/s40263-022-00958-6. Epub 2022 Nov 8.
PubMed 36346534
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa
- ClinicalTrials.gov ID
- NCT03881371
- Acronym / sponsor ID
- Z7219L05
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Zambon SpAIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 20 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safinamide | Experimental | Drug: SafinamidePatient 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. |
| Placebo | Placebo comparator | Other: PlaceboPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patients aged ≥18 years old.
- Chinese ethnicity.
- Able to understand and willing to provide written informed consent.
- Able to maintain an accurate and complete 24-hour diary with the help of a caregiver.
- Diagnosis of idiopathic Parkinson's Disease (IPD) using the United Kingdom Parkinson's Disease Society Brain Bank criteria of more than 3 years duration.
Key exclusion criteria (16 listed)
- Any form of Parkinsonism other than IPD.
- Diagnosis of chronic migraine (>15 days per month) or cancer pain.
- L-dopa infusion.
- Hoehn and Yahr stage 5 during the "ON" phase.
- If female, pregnancy or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafinamideAt 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. | Drug | Safinamide |
| PlaceboAt 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 | Other | Placebo |
Primary outcome
Change From Baseline to Week 16 in the Mean Total Daily "OFF" Time
Time frame: At baseline and Week 16
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).
9 secondary outcomes
Change From Baseline to Week 16 in Pain Severity, as Assessed by an 11 Point Numerical Rating Scale (NRS)
Time frame: At baseline and Week 16
Change From Baseline to Week 16 in the Mean Total Daily "ON" Time
Time frame: At baseline and Week 16
Change From Baseline to Week 16 in the Mean Daily "ON" Time With no/Non Troublesome Dyskinesia
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
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
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
Time frame: At baseline and Week 16
Clinical Global Impression of Severity (CGI-S) Score Assessed at Week 16
Time frame: At week 16
Clinical Global Impression of Change (CGI-C) Assessed at Week 16
Time frame: At baseline and Week 16
Change From Baseline to Week 16 in the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Score
Time frame: At baseline and Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38565814Dei Cas A, Micheli MM, Aldigeri R, Gardini S, Ferrari-Pellegrini F, Perini M, Messa G, Antonini M, Spigoni V, Cinquegrani G, Vazzana A, Moretti V, Caffarra P, Bonadonna RC. Long-acting exenatide does not prevent cognitive decline in mild cognitive impairment: a proof-of-concept clinical trial. J Endocrinol Invest. 2024 Sep;47(9):2339-2349. doi: 10.1007/s40618-024-02320-7. Epub 2024 Apr 2.
- Derived from this study: PubMed 38070039Cattaneo C, Kulisevsky J. The Effects of Safinamide in Chinese and Non-Chinese Patients with Parkinson's Disease. Adv Ther. 2024 Feb;41(2):638-648. doi: 10.1007/s12325-023-02736-2. Epub 2023 Dec 9.
- Derived from this study: PubMed 36346534Wei Q, Tan Y, Xu P, Tao E, Lu Z, Pan X, Wang B, Liu C, Dong X, Tian Y, Sun X, Cattaneo C, Chen S, Shang H; XINDI Study Investigators Group. The XINDI Study: A Randomized Phase III Clinical Trial Evaluating the Efficacy and Safety of Safinamide as Add-On Therapy to Levodopa in Chinese Patients with Parkinson's Disease with Motor Fluctuations. CNS Drugs. 2022 Nov;36(11):1217-1227. doi: 10.1007/s40263-022-00958-6. Epub 2022 Nov 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Safinamide in people with Parkinson Disease, run by Zambon SpA at 31 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 16 in the Mean Total Daily "OFF" Time (time frame: At baseline and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03881371, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.