Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease

NCT01187966 | Completed Phase 3 DMC

• 1 other identifier: NW-1015/016/III/2006
• Study Type: interventional
• Target: 669
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; PD; Levodopa; Patients with idiopathic Parkinson's disease with motor fluctuations

Outcome Measures

Primary Outcomes (1)

• 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

  baseline to endpoint

Secondary Outcomes (1)

• Decrease in total daily "off" time

  baseline to endpoint

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Drug: Placebo

High Dose (100mg/day)

EXPERIMENTAL

Drug: Safinamide

Low dose (50mg/day)

EXPERIMENTAL

Drug: Safinamide

Interventions

Safinamide DRUG

Low dose (50mg/day)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Newron Pharmaceuticals SPA: lead

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Interventions

safinamide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mohit Bhatt, MD

  Jaslok Hospital, Mumbai

  PRINCIPAL INVESTIGATOR

• Neeta Mehta, MD

  J.J Hospital, Mumbai

  PRINCIPAL INVESTIGATOR

• Sankhla Charulata, MD

  P.D. Hinduja Hospital, Mumbai

  PRINCIPAL INVESTIGATOR

• Ajit Sowani, MD

  Neurology Centre, Ahmedabad

  PRINCIPAL INVESTIGATOR

• Prosenjit Chakraborty, MD

  Roby General Hospital, Kolkata

  PRINCIPAL INVESTIGATOR

• Sudhir Kothari, MD

  Poona Hospital, Pune

  PRINCIPAL INVESTIGATOR

• Sunil Bandishti, MD

  Ruby Hall Clinic, Pune

  PRINCIPAL INVESTIGATOR

• CU Velmurugendran, MD

  Sri Ramachandra Medical College, Chennai

  PRINCIPAL INVESTIGATOR

• Suresh Kumar, MD

  Vijaya Health Centre, Chennai

  PRINCIPAL INVESTIGATOR

• Devanathan Vasudevan, MD

  Kamakshi Memorial Hospital, Chennai

  PRINCIPAL INVESTIGATOR

• Rupam Borgohain, MD

  Nizams Institute of Medical Sciences, Hyderabad

  PRINCIPAL INVESTIGATOR

• J.K Murthy, MD

  CARE Hospital, Hyderabad

  PRINCIPAL INVESTIGATOR

• Vavilikolanu Prasad, MD

  Owasis Hospital & Research Centre, Hyderabad

  PRINCIPAL INVESTIGATOR

• Subashini Prabhakar, MD

  Spectra Clinical Research Centre, Hyderabad

  PRINCIPAL INVESTIGATOR

• Keshava Belur, MD

  J.S.S. Hospital Agrahara, Mysore

  PRINCIPAL INVESTIGATOR

• Pramod Pal, MD

  NIMHANS, Bangalore

  PRINCIPAL INVESTIGATOR

• Ajit Kumar Roy, MD

  St. Johns Medical College and Hospital, Bangalore

  PRINCIPAL INVESTIGATOR

• Rangashetti Srinivasa, MD

  M.S. Ramaiah Memoria Hospital, Bangalore

  PRINCIPAL INVESTIGATOR

• Arun B Shah, MD

  T.N.M.C and B.Y.L Nair Hospital, Mumbai

  PRINCIPAL INVESTIGATOR

• Krishnan Vijayan, MD

  Kovai Medical Centre and Hospital, Coimbatore

  PRINCIPAL INVESTIGATOR

• Neeta Mehta, MD

  Neeta Mehta's Clinic, Mumbai

  PRINCIPAL INVESTIGATOR

• Chandrashekhar Meshram, MD

  Brain and Mind Institute, Nagpur

  PRINCIPAL INVESTIGATOR

• Nellikunja Shankar, MD

  Mallikatta Neuro and Research Centre, Mangalore

  PRINCIPAL INVESTIGATOR

• Asha Kishore, MD

  Sree Chitra Tirual Institute for Sciences and Technology, Kerela

  PRINCIPAL INVESTIGATOR

• Ummer Karadan, MD

  Baby Memorial Hospital, Calicut

  PRINCIPAL INVESTIGATOR

• Mohammad I Sahadulla, MD

  Kerala Institute of Medical Sciences, Trivandrum

  PRINCIPAL INVESTIGATOR

• Madhuri Behari, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Prahlad K Sethi, MD

  Sir Ganga Ram Hospital, New Delhi

  PRINCIPAL INVESTIGATOR

• Shamsher Dwivedee, MD

  Vidyasagar Institute of Mental Health and Neurosciences, New Delhi

  PRINCIPAL INVESTIGATOR

• Mukul Varma, MD

  Indraprastha Apollo Hospital, New Delhi

  PRINCIPAL INVESTIGATOR

• Rajinder Bansal, MD

  Dayanand Medical College and Hospital, Ludhiana

  PRINCIPAL INVESTIGATOR

• Sudesh Prabhakar, MD

  Post Grad Institute of Medical Education,& Research Dept of Neurology, Chandigarh

  PRINCIPAL INVESTIGATOR

• Sunil Pradhan, MD

  Institute of Human Behaviour and Allied Sciences, Dilshad Garden Delhi

  PRINCIPAL INVESTIGATOR

• Rakesh Shukla, MD

  Chhatrapati Sahuji Maharaj Medical University, Lucknow

  PRINCIPAL INVESTIGATOR

• Pahari Ghosh, MD

  Sri Aurbindo Seva Kendra, Kolkata

  PRINCIPAL INVESTIGATOR

• Ovidiu Bajenaru, MD

  University Hospital of Emergency Hospital, Bucuresti

  PRINCIPAL INVESTIGATOR

• Cristina Panea, MD

  Elias University Hospital, Bucuresti

  PRINCIPAL INVESTIGATOR

• Ana Campeanu, MD

  Fundeni Hospital, Bucuresti

  PRINCIPAL INVESTIGATOR

• Marina Ticmeanu, MD

  colentina Hospital, Bucuresti

  PRINCIPAL INVESTIGATOR

• Dafin Muresanu, MD

  Emergency Hospital Cluj, Cluj

  PRINCIPAL INVESTIGATOR

• Angelo Bulboaca, MD

  Rehabilitation Hospital Cluj, Cluj

  PRINCIPAL INVESTIGATOR

• Jozsef Szasz, MD

  Emergency Hospital Targu-Mures, Targu Mures

  PRINCIPAL INVESTIGATOR

• Cristian Dinu Popescu, MD

  Rehabiliation Hospital Iasi, Iasi

  PRINCIPAL INVESTIGATOR

• Mihaela Simu, MD

  Emergency Hospital Timisoara no. 1, Timisoara

  PRINCIPAL INVESTIGATOR

• Dana Chirileanu, MD

  Emergency Hospital Timisoara no.1, Timisoara

  PRINCIPAL INVESTIGATOR

• Roberto Eleopra, MD

  Ospedale dell'Angelo, Venezia

  PRINCIPAL INVESTIGATOR

• Rocco Quatrale, MD

  Arcispedale S. Anna, Ferrara

  PRINCIPAL INVESTIGATOR

• Marco Onofri, MD

  Centro dell'invecchiamento, Chieti

  PRINCIPAL INVESTIGATOR

• Tanina Pia Avarello, MD

  Centro di Riferimento Regionale Malattie Extra Piramidali, Palermo

  PRINCIPAL INVESTIGATOR

• Ubaldo Bonuccelli, MD

  Ospedale di Viareggio, Viareggio

  PRINCIPAL INVESTIGATOR

• Giovanni Fabbrini, MD

  Dip. Scienze Neurologiche, Roma

  PRINCIPAL INVESTIGATOR

• Paolo Stanzione, MD

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

• Fabrizio Stocchi, MD

  IRCCS S. Raffaele Pisana, Roma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 31, 2010
• First Posted: August 24, 2010
• Study Start: January 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: February 1, 2009
• Last Updated: August 24, 2010

Record last verified: 2010-08