Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Safinamide
Safinamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, PD, Levodopa, Patients with idiopathic Parkinson's disease with motor fluctuations
Eligibility Criteria
Inclusion Criteria:
- Patients are male or female, age 30-80 years, inclusive. If female, they must be either post-menopausal for at least 12 months, surgically sterilized or have undergone hysterectomy. Patients older than 80 years, who meet all other entry criteria, will be considered for enrollment, with approval of the Newron Medical Expert.
- Patients must have a diagnosis of idiopathic Parkinson's disease of more than 5 years duration; the diagnosis should be based on medical history and neurological examination. Patients with a duration of Parkinson's disease of at least 3 years, who meet all other entry criteria, will be considered for enrollment, with approval of the CRO Medical Monitor.
- Patients must have a Hoehn and Yahr stage of I-IV during an "off" phase.
- Patients should be levodopa responsive and must have been receiving treatment with a stable dose of levodopa [4-10 doses per day of any levodopa preparation (including CR, IR or a combination of CR/IR), plus benserazide/carbidopa; with or without addition of a COMT inhibitor] and may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic at the screening visit. Patients will receive the study medication as add-on therapy starting at baseline.
- Patients should have motor fluctuations, with >1.5 hours "off" time during the day.
- Patients must be able to maintain an accurate and complete diary (18-hour), with the help of a caregiver, recording "on" time, "on" time with minor dyskinesia, "on" time with troublesome dyskinesia, "off" time, and time asleep.
- Patients must be able to understand and willing to sign an approved Informed Consent form.
Exclusion Criteria:
- The patient has any indication of forms of parkinsonism other than idiopathic Parkinson's disease.
- If female, the patient is of childbearing potential, pregnant or lactating.
- The patient is in a late stage of Parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms.
- The patient has a current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past 3 months.
- The patient has a current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including acute gastric ulcer, hypertension that is not well-controlled, asthma, chronic obstructive pulmonary disease (COPD), and Type I diabetes. Patients with a history of gastric ulcer who have not had an episode of acute gastritis in the last 6 months and are not currently experiencing gastric pain will be eligible for inclusion.
- The patient has second- or third-degree atrio-ventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or a significant ECG abnormality, including QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method.
- The patient has participated in a previous clinical trial with safinamide.
- The patient has a concomitant disease likely to interfere with the study medication (e.g. capable of altering absorption, metabolism or elimination of the study drug).
- The patient has a history of psychosis (e.g. schizophrenia or psychotic depression), either previously or currently, or a score ≥ 3 on Item 2 (thought disorder) or 3 (depression) of the UPDRS Section I.
- The patient has evidence of dementia or cognitive dysfunction, as indicated by a MMSE score < 22, or a score ≥ 3 on item 1 (mentation) of the UPDRS, Section I.
- The patient is depressed, as indicated by a GRID-HAMD (17-item scale) score > 17.
- The patient has a history of allergic response to anticonvulsants, levodopa, or other anti-parkinsonian agents.
- The patient has a mental or physical condition (e.g., neurotic behaviour, crippling degenerative arthritis, or limb amputation), which would preclude performing efficacy or safety assessments.
- The patient has hypersenstivity or contraindications to MAO B inhibitors.
- The patient has a current history of severe dizziness or fainting on standing, due to postural hypotension.
- The patient has a neoplastic disorder, which is either currently active or has been in remission for less than one year.
- The patient has had stereotactic surgery as a treatment for his/her Parkinson's disease.
- The patient has participated in a previous clinical trial within 30 days of entry into the study (screening visit) or has received treatment with any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to screening. The use of an investigational drug other than safinamide during the study is not permitted.
- The patient is receiving treatment of his/her depression with a MAO inhibitor (e.g., selegiline), a tricyclic, or an SNRI (e.g., venlafaxine, duloxetine) at the screening visit. Note: Use of SSRIs will be permitted, provided the dose is kept as low as possible and remains stable throughout the trial.
- The patient is receiving treatment of his/her parkinsonian symptoms with a MAO inhibitor. Note: Patients receiving amantadine, COMT inhibitors, DA agonists and/or anticholinergics will be eligible to enter the trial, provided they are on a stable dose at screening.
- The patient has received treatment with any agent known to significantly inhibit or induce drug-metabolizing enyzmes (e.g., barbiturates, phenothiazines, etc.) within 4 weeks preceding the screening visit.
- The patient has received treatment with opioids (e.g., tramadol, meperidine derivatives), in the 4 weeks prior to the screening visit.
- The patient has received treatment with a depot neuroleptic within one injection cycle, or oral neuroleptics within 4 weeks prior to the screening visit. Patients who are receiving a low dose of an oral neuroleptic for treatment of psychotic symptoms (e.g., hallucinations) related to their Parkinson's disease or anti-parkinsonian medication, and who meet all other entry criteria, will be considered for enrollment, with approval of the CRO Medical Monitor. The Investigator must agree not to increase the dose of the oral neuroleptic during the trial, unless required for significant worsening.
- The patient has received treatment with a drug that has hepatotoxic potential, e.g., tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g, chemotherapy, within one year prior to the screening visit.
- The patient has a history or a current diagnosis of HIV, tests positive for Hepatitis B surface antigen, tests positive for Hepatitis B core antibody, but negative for Hepatitis B surface antibody, or tests positive for Hepatitis C antibodies.
- The patient has any abnormality that the investigator deems to be clinically relevant, either on medical history, physical examination, ECG or a diagnostic laboratory test.
- In the judgment of the Clinical Investigator the patient is likely to be non-compliant or uncooperative during the study.
- Ophthalmologic history including any of the following conditions: albino patients, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or progressive, severe diabetic retinopathy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
High Dose (100mg/day)
Low dose (50mg/day)
Arm Description
Drug: Placebo
Outcomes
Primary Outcome Measures
Increase in mean daily "on" time
Increase in mean daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia) during 18-hr diary recording period
Secondary Outcome Measures
Decrease in total daily "off" time
Decrease in total daily "off" time, UPDRS Section III during "on" phase (based on diary) - mean change from baseline to endpoint, CGI - Change from baseline - mean score in the course of the study, change in cognition (cognitive test battery), decrease in mean "off" time following first morning dose of levodopa, improvement in the Dyskinesias Rating Scale during "on" phase, UPDRS Section II during "on" phase (based on diary),CGI- Severity of illness - mean change from baseline to endpoint, mean percent change in levodopa dose
Full Information
NCT ID
NCT01187966
First Posted
May 31, 2010
Last Updated
August 23, 2010
Sponsor
Newron Pharmaceuticals SPA
1. Study Identification
Unique Protocol Identification Number
NCT01187966
Brief Title
Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease
Official Title
A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, and/or an Anticholinergic
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Newron Pharmaceuticals SPA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o.), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations who are currently receiving a stable dose of levodopa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, PD, Levodopa, Patients with idiopathic Parkinson's disease with motor fluctuations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
669 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo
Arm Title
High Dose (100mg/day)
Arm Type
Experimental
Arm Title
Low dose (50mg/day)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Safinamide
Intervention Type
Drug
Intervention Name(s)
Safinamide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Increase in mean daily "on" time
Description
Increase in mean daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia) during 18-hr diary recording period
Time Frame
baseline to endpoint
Secondary Outcome Measure Information:
Title
Decrease in total daily "off" time
Description
Decrease in total daily "off" time, UPDRS Section III during "on" phase (based on diary) - mean change from baseline to endpoint, CGI - Change from baseline - mean score in the course of the study, change in cognition (cognitive test battery), decrease in mean "off" time following first morning dose of levodopa, improvement in the Dyskinesias Rating Scale during "on" phase, UPDRS Section II during "on" phase (based on diary),CGI- Severity of illness - mean change from baseline to endpoint, mean percent change in levodopa dose
Time Frame
baseline to endpoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are male or female, age 30-80 years, inclusive. If female, they must be either post-menopausal for at least 12 months, surgically sterilized or have undergone hysterectomy. Patients older than 80 years, who meet all other entry criteria, will be considered for enrollment, with approval of the Newron Medical Expert.
Patients must have a diagnosis of idiopathic Parkinson's disease of more than 5 years duration; the diagnosis should be based on medical history and neurological examination. Patients with a duration of Parkinson's disease of at least 3 years, who meet all other entry criteria, will be considered for enrollment, with approval of the CRO Medical Monitor.
Patients must have a Hoehn and Yahr stage of I-IV during an "off" phase.
Patients should be levodopa responsive and must have been receiving treatment with a stable dose of levodopa [4-10 doses per day of any levodopa preparation (including CR, IR or a combination of CR/IR), plus benserazide/carbidopa; with or without addition of a COMT inhibitor] and may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic at the screening visit. Patients will receive the study medication as add-on therapy starting at baseline.
Patients should have motor fluctuations, with >1.5 hours "off" time during the day.
Patients must be able to maintain an accurate and complete diary (18-hour), with the help of a caregiver, recording "on" time, "on" time with minor dyskinesia, "on" time with troublesome dyskinesia, "off" time, and time asleep.
Patients must be able to understand and willing to sign an approved Informed Consent form.
Exclusion Criteria:
The patient has any indication of forms of parkinsonism other than idiopathic Parkinson's disease.
If female, the patient is of childbearing potential, pregnant or lactating.
The patient is in a late stage of Parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms.
The patient has a current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past 3 months.
The patient has a current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including acute gastric ulcer, hypertension that is not well-controlled, asthma, chronic obstructive pulmonary disease (COPD), and Type I diabetes. Patients with a history of gastric ulcer who have not had an episode of acute gastritis in the last 6 months and are not currently experiencing gastric pain will be eligible for inclusion.
The patient has second- or third-degree atrio-ventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or a significant ECG abnormality, including QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method.
The patient has participated in a previous clinical trial with safinamide.
The patient has a concomitant disease likely to interfere with the study medication (e.g. capable of altering absorption, metabolism or elimination of the study drug).
The patient has a history of psychosis (e.g. schizophrenia or psychotic depression), either previously or currently, or a score ≥ 3 on Item 2 (thought disorder) or 3 (depression) of the UPDRS Section I.
The patient has evidence of dementia or cognitive dysfunction, as indicated by a MMSE score < 22, or a score ≥ 3 on item 1 (mentation) of the UPDRS, Section I.
The patient is depressed, as indicated by a GRID-HAMD (17-item scale) score > 17.
The patient has a history of allergic response to anticonvulsants, levodopa, or other anti-parkinsonian agents.
The patient has a mental or physical condition (e.g., neurotic behaviour, crippling degenerative arthritis, or limb amputation), which would preclude performing efficacy or safety assessments.
The patient has hypersenstivity or contraindications to MAO B inhibitors.
The patient has a current history of severe dizziness or fainting on standing, due to postural hypotension.
The patient has a neoplastic disorder, which is either currently active or has been in remission for less than one year.
The patient has had stereotactic surgery as a treatment for his/her Parkinson's disease.
The patient has participated in a previous clinical trial within 30 days of entry into the study (screening visit) or has received treatment with any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to screening. The use of an investigational drug other than safinamide during the study is not permitted.
The patient is receiving treatment of his/her depression with a MAO inhibitor (e.g., selegiline), a tricyclic, or an SNRI (e.g., venlafaxine, duloxetine) at the screening visit. Note: Use of SSRIs will be permitted, provided the dose is kept as low as possible and remains stable throughout the trial.
The patient is receiving treatment of his/her parkinsonian symptoms with a MAO inhibitor. Note: Patients receiving amantadine, COMT inhibitors, DA agonists and/or anticholinergics will be eligible to enter the trial, provided they are on a stable dose at screening.
The patient has received treatment with any agent known to significantly inhibit or induce drug-metabolizing enyzmes (e.g., barbiturates, phenothiazines, etc.) within 4 weeks preceding the screening visit.
The patient has received treatment with opioids (e.g., tramadol, meperidine derivatives), in the 4 weeks prior to the screening visit.
The patient has received treatment with a depot neuroleptic within one injection cycle, or oral neuroleptics within 4 weeks prior to the screening visit. Patients who are receiving a low dose of an oral neuroleptic for treatment of psychotic symptoms (e.g., hallucinations) related to their Parkinson's disease or anti-parkinsonian medication, and who meet all other entry criteria, will be considered for enrollment, with approval of the CRO Medical Monitor. The Investigator must agree not to increase the dose of the oral neuroleptic during the trial, unless required for significant worsening.
The patient has received treatment with a drug that has hepatotoxic potential, e.g., tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g, chemotherapy, within one year prior to the screening visit.
The patient has a history or a current diagnosis of HIV, tests positive for Hepatitis B surface antigen, tests positive for Hepatitis B core antibody, but negative for Hepatitis B surface antibody, or tests positive for Hepatitis C antibodies.
The patient has any abnormality that the investigator deems to be clinically relevant, either on medical history, physical examination, ECG or a diagnostic laboratory test.
In the judgment of the Clinical Investigator the patient is likely to be non-compliant or uncooperative during the study.
Ophthalmologic history including any of the following conditions: albino patients, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or progressive, severe diabetic retinopathy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohit Bhatt, MD
Organizational Affiliation
Jaslok Hospital, Mumbai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neeta Mehta, MD
Organizational Affiliation
J.J Hospital, Mumbai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sankhla Charulata, MD
Organizational Affiliation
P.D. Hinduja Hospital, Mumbai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ajit Sowani, MD
Organizational Affiliation
Neurology Centre, Ahmedabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prosenjit Chakraborty, MD
Organizational Affiliation
Roby General Hospital, Kolkata
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sudhir Kothari, MD
Organizational Affiliation
Poona Hospital, Pune
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sunil Bandishti, MD
Organizational Affiliation
Ruby Hall Clinic, Pune
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CU Velmurugendran, MD
Organizational Affiliation
Sri Ramachandra Medical College, Chennai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suresh Kumar, MD
Organizational Affiliation
Vijaya Health Centre, Chennai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Devanathan Vasudevan, MD
Organizational Affiliation
Kamakshi Memorial Hospital, Chennai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rupam Borgohain, MD
Organizational Affiliation
Nizams Institute of Medical Sciences, Hyderabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J.K Murthy, MD
Organizational Affiliation
CARE Hospital, Hyderabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vavilikolanu Prasad, MD
Organizational Affiliation
Owasis Hospital & Research Centre, Hyderabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Subashini Prabhakar, MD
Organizational Affiliation
Spectra Clinical Research Centre, Hyderabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keshava Belur, MD
Organizational Affiliation
J.S.S. Hospital Agrahara, Mysore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pramod Pal, MD
Organizational Affiliation
NIMHANS, Bangalore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ajit Kumar Roy, MD
Organizational Affiliation
St. Johns Medical College and Hospital, Bangalore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rangashetti Srinivasa, MD
Organizational Affiliation
M.S. Ramaiah Memoria Hospital, Bangalore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arun B Shah, MD
Organizational Affiliation
T.N.M.C and B.Y.L Nair Hospital, Mumbai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Krishnan Vijayan, MD
Organizational Affiliation
Kovai Medical Centre and Hospital, Coimbatore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neeta Mehta, MD
Organizational Affiliation
Neeta Mehta's Clinic, Mumbai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chandrashekhar Meshram, MD
Organizational Affiliation
Brain and Mind Institute, Nagpur
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nellikunja Shankar, MD
Organizational Affiliation
Mallikatta Neuro and Research Centre, Mangalore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asha Kishore, MD
Organizational Affiliation
Sree Chitra Tirual Institute for Sciences and Technology, Kerela
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ummer Karadan, MD
Organizational Affiliation
Baby Memorial Hospital, Calicut
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad I Sahadulla, MD
Organizational Affiliation
Kerala Institute of Medical Sciences, Trivandrum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Madhuri Behari, MD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prahlad K Sethi, MD
Organizational Affiliation
Sir Ganga Ram Hospital, New Delhi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shamsher Dwivedee, MD
Organizational Affiliation
Vidyasagar Institute of Mental Health and Neurosciences, New Delhi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mukul Varma, MD
Organizational Affiliation
Indraprastha Apollo Hospital, New Delhi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajinder Bansal, MD
Organizational Affiliation
Dayanand Medical College and Hospital, Ludhiana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sudesh Prabhakar, MD
Organizational Affiliation
Post Grad Institute of Medical Education,& Research Dept of Neurology, Chandigarh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sunil Pradhan, MD
Organizational Affiliation
Institute of Human Behaviour and Allied Sciences, Dilshad Garden Delhi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rakesh Shukla, MD
Organizational Affiliation
Chhatrapati Sahuji Maharaj Medical University, Lucknow
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pahari Ghosh, MD
Organizational Affiliation
Sri Aurbindo Seva Kendra, Kolkata
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ovidiu Bajenaru, MD
Organizational Affiliation
University Hospital of Emergency Hospital, Bucuresti
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristina Panea, MD
Organizational Affiliation
Elias University Hospital, Bucuresti
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Campeanu, MD
Organizational Affiliation
Fundeni Hospital, Bucuresti
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marina Ticmeanu, MD
Organizational Affiliation
colentina Hospital, Bucuresti
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dafin Muresanu, MD
Organizational Affiliation
Emergency Hospital Cluj, Cluj
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angelo Bulboaca, MD
Organizational Affiliation
Rehabilitation Hospital Cluj, Cluj
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jozsef Szasz, MD
Organizational Affiliation
Emergency Hospital Targu-Mures, Targu Mures
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristian Dinu Popescu, MD
Organizational Affiliation
Rehabiliation Hospital Iasi, Iasi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mihaela Simu, MD
Organizational Affiliation
Emergency Hospital Timisoara no. 1, Timisoara
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana Chirileanu, MD
Organizational Affiliation
Emergency Hospital Timisoara no.1, Timisoara
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Eleopra, MD
Organizational Affiliation
Ospedale dell'Angelo, Venezia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rocco Quatrale, MD
Organizational Affiliation
Arcispedale S. Anna, Ferrara
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marco Onofri, MD
Organizational Affiliation
Centro dell'invecchiamento, Chieti
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tanina Pia Avarello, MD
Organizational Affiliation
Centro di Riferimento Regionale Malattie Extra Piramidali, Palermo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ubaldo Bonuccelli, MD
Organizational Affiliation
Ospedale di Viareggio, Viareggio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giovanni Fabbrini, MD
Organizational Affiliation
Dip. Scienze Neurologiche, Roma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paolo Stanzione, MD
Organizational Affiliation
University of Rome Tor Vergata
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabrizio Stocchi, MD
Organizational Affiliation
IRCCS S. Raffaele Pisana, Roma
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.newron.com/
Description
Related Info
Learn more about this trial
Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease
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