Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease
Launched by NEWRON PHARMACEUTICALS SPA · Aug 23, 2010
Trial Information
Current as of May 04, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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.
About Newron Pharmaceuticals Spa
Newron Pharmaceuticals S.p.A. is a biopharmaceutical company focused on the development of innovative therapies for patients with central nervous system (CNS) disorders and pain. Headquartered in Italy, Newron is dedicated to addressing unmet medical needs through advanced research and clinical trials. The company’s pipeline includes a range of novel compounds designed to improve treatment outcomes for conditions such as schizophrenia, Parkinson's disease, and neuropathic pain. With a commitment to excellence in scientific rigor and patient care, Newron Pharmaceuticals aims to enhance the quality of life for individuals affected by debilitating neurological conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Mohit Bhatt, MD
Principal Investigator
Jaslok Hospital, Mumbai
Neeta Mehta, MD
Principal Investigator
J.J Hospital, Mumbai
Sankhla Charulata, MD
Principal Investigator
P.D. Hinduja Hospital, Mumbai
Ajit Sowani, MD
Principal Investigator
Neurology Centre, Ahmedabad
Prosenjit Chakraborty, MD
Principal Investigator
Roby General Hospital, Kolkata
Sudhir Kothari, MD
Principal Investigator
Poona Hospital, Pune
Sunil Bandishti, MD
Principal Investigator
Ruby Hall Clinic, Pune
CU Velmurugendran, MD
Principal Investigator
Sri Ramachandra Medical College, Chennai
Suresh Kumar, MD
Principal Investigator
Vijaya Health Centre, Chennai
Devanathan Vasudevan, MD
Principal Investigator
Kamakshi Memorial Hospital, Chennai
Rupam Borgohain, MD
Principal Investigator
Nizams Institute of Medical Sciences, Hyderabad
J.K Murthy, MD
Principal Investigator
CARE Hospital, Hyderabad
Vavilikolanu Prasad, MD
Principal Investigator
Owasis Hospital & Research Centre, Hyderabad
Subashini Prabhakar, MD
Principal Investigator
Spectra Clinical Research Centre, Hyderabad
Keshava Belur, MD
Principal Investigator
J.S.S. Hospital Agrahara, Mysore
Pramod Pal, MD
Principal Investigator
NIMHANS, Bangalore
Ajit Kumar Roy, MD
Principal Investigator
St. Johns Medical College and Hospital, Bangalore
Rangashetti Srinivasa, MD
Principal Investigator
M.S. Ramaiah Memoria Hospital, Bangalore
Arun B Shah, MD
Principal Investigator
T.N.M.C and B.Y.L Nair Hospital, Mumbai
Krishnan Vijayan, MD
Principal Investigator
Kovai Medical Centre and Hospital, Coimbatore
Neeta Mehta, MD
Principal Investigator
Neeta Mehta's Clinic, Mumbai
Chandrashekhar Meshram, MD
Principal Investigator
Brain and Mind Institute, Nagpur
Nellikunja Shankar, MD
Principal Investigator
Mallikatta Neuro and Research Centre, Mangalore
Asha Kishore, MD
Principal Investigator
Sree Chitra Tirual Institute for Sciences and Technology, Kerela
Ummer Karadan, MD
Principal Investigator
Baby Memorial Hospital, Calicut
Mohammad I Sahadulla, MD
Principal Investigator
Kerala Institute of Medical Sciences, Trivandrum
Madhuri Behari, MD
Principal Investigator
All India Institute of Medical Sciences, New Delhi
Prahlad K Sethi, MD
Principal Investigator
Sir Ganga Ram Hospital, New Delhi
Shamsher Dwivedee, MD
Principal Investigator
Vidyasagar Institute of Mental Health and Neurosciences, New Delhi
Mukul Varma, MD
Principal Investigator
Indraprastha Apollo Hospital, New Delhi
Rajinder Bansal, MD
Principal Investigator
Dayanand Medical College and Hospital, Ludhiana
Sudesh Prabhakar, MD
Principal Investigator
Post Grad Institute of Medical Education,& Research Dept of Neurology, Chandigarh
Sunil Pradhan, MD
Principal Investigator
Institute of Human Behaviour and Allied Sciences, Dilshad Garden Delhi
Rakesh Shukla, MD
Principal Investigator
Chhatrapati Sahuji Maharaj Medical University, Lucknow
Pahari Ghosh, MD
Principal Investigator
Sri Aurbindo Seva Kendra, Kolkata
Ovidiu Bajenaru, MD
Principal Investigator
University Hospital of Emergency Hospital, Bucuresti
Cristina Panea, MD
Principal Investigator
Elias University Hospital, Bucuresti
Ana Campeanu, MD
Principal Investigator
Fundeni Hospital, Bucuresti
Marina Ticmeanu, MD
Principal Investigator
colentina Hospital, Bucuresti
Dafin Muresanu, MD
Principal Investigator
Emergency Hospital Cluj, Cluj
Angelo Bulboaca, MD
Principal Investigator
Rehabilitation Hospital Cluj, Cluj
Jozsef Szasz, MD
Principal Investigator
Emergency Hospital Targu-Mures, Targu Mures
Cristian Dinu Popescu, MD
Principal Investigator
Rehabiliation Hospital Iasi, Iasi
Mihaela Simu, MD
Principal Investigator
Emergency Hospital Timisoara no. 1, Timisoara
Dana Chirileanu, MD
Principal Investigator
Emergency Hospital Timisoara no.1, Timisoara
Roberto Eleopra, MD
Principal Investigator
Ospedale dell'Angelo, Venezia
Rocco Quatrale, MD
Principal Investigator
Arcispedale S. Anna, Ferrara
Marco Onofri, MD
Principal Investigator
Centro dell'invecchiamento, Chieti
Tanina Pia Avarello, MD
Principal Investigator
Centro di Riferimento Regionale Malattie Extra Piramidali, Palermo
Ubaldo Bonuccelli, MD
Principal Investigator
Ospedale di Viareggio, Viareggio
Giovanni Fabbrini, MD
Principal Investigator
Dip. Scienze Neurologiche, Roma
Paolo Stanzione, MD
Principal Investigator
University of Rome Tor Vergata
Fabrizio Stocchi, MD
Principal Investigator
IRCCS S. Raffaele Pisana, Roma
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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