Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Safinamide

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    21 result(s) found for: Safinamide. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-005492-94 Sponsor Protocol Number: 28850 Start Date*: 2009-04-30
    Sponsor Name:MERCK SERONO SA
    Full Title: OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS
    Medical condition: IDIOPATHIC PARKINSON`S DISEASE
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061536 Parkinson's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed) BE (Completed) GB (Completed) AT (Completed) EE (Completed) ES (Completed) HU (Completed) NL (Completed) FR (Completed) SK (Prematurely Ended) CZ (Completed) FI (Completed) PT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2007-002964-90 Sponsor Protocol Number: 27919 Start Date*: 2011-05-05
    Sponsor Name:Newron Pharmaceuticals SpA
    Full Title: A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathi...
    Medical condition: Idiopathic Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FI (Prematurely Ended) FR (Completed) HU (Completed) ES (Completed) NL (Completed) EE (Completed) AT (Completed) SK (Completed) DE (Completed) GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2018-004145-16 Sponsor Protocol Number: Z7219K01 Start Date*: 2019-07-24
    Sponsor Name:Zambon SpA
    Full Title: A 12-weeks, multicentre, randomized, double-blind, placebo-controlled, exploratory, pilot study to evaluate the safety and efficacy of safinamide 200 mg once daily, as add-on therapy, in patients w...
    Medical condition: Parkinsonian variant of Multiple System Atrophy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10064060 Multiple system atrophy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002239-41 Sponsor Protocol Number: SC17.01 Start Date*: 2018-02-16
    Sponsor Name:I.R.C.C.S. FONDAZIONE S.LUCIA
    Full Title: Effects of Safinamide therapy on reuroplasticity in patients with Parkinson's disease
    Medical condition: Parkinson's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-003254-17 Sponsor Protocol Number: IIBSP-SAF-2017-75 Start Date*: 2017-12-21
    Sponsor Name:Institut de Recerca Hospital de la Santa Creu i Sant Pau
    Full Title: A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Safinamide on Apathy in Patients With Parkinson's Disease
    Medical condition: Parkinson's disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-002600-24 Sponsor Protocol Number: Z7219L02 Start Date*: 2015-11-03
    Sponsor Name:Zambon S.P.A.
    Full Title: A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSO...
    Medical condition: Idiopathic Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Prematurely Ended) AT (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-002769-30 Sponsor Protocol Number: 28780 Start Date*: 2009-04-30
    Sponsor Name:MERCK SERONO SA
    Full Title: A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson�s dis...
    Medical condition: Parkinson Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013113 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-000833-12 Sponsor Protocol Number: NW-1015/015/III/2003 Start Date*: 2004-12-02
    Sponsor Name:Newron Pharmaceuticals S.p.A.
    Full Title: A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients ...
    Medical condition: Early idiopathic Parkinson’s disease
    Disease: Version SOC Term Classification Code Term Level
    7.0 10013113 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-000835-27 Sponsor Protocol Number: NW-1015/017/III/2003 Start Date*: 2004-12-03
    Sponsor Name:NEWRON PHARMACEUTICALS
    Full Title: A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with ear...
    Medical condition: Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    6.1 10061536 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-004146-88 Sponsor Protocol Number: 27938 Start Date*: 2009-05-19
    Sponsor Name:Newron Pharmaceuticals
    Full Title: A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subject...
    Medical condition: Idiopathic Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) CZ (Completed) PT (Completed) ES (Completed) IT (Completed) SK (Completed) BG (Completed) PL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002963-28 Sponsor Protocol Number: 27918 Start Date*: 2007-12-12
    Sponsor Name:Newron Pharmaceuticals SpA
    Full Title: A phase III, double-blind, placebo-controlled randomised trial 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 subjects wit...
    Medical condition: Idiopathic Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) CZ (Completed) ES (Completed) IT (Completed) SK (Completed) PT (Completed) PL (Completed) BG (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-001966-10 Sponsor Protocol Number: 27937 Start Date*: 2009-05-04
    Sponsor Name:Merck Serono SA - Geneva
    Full Title: A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parki...
    Medical condition: Idiopathic Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061536 Parkinson's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) AT (Completed) GB (Prematurely Ended) EE (Prematurely Ended) SK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004892-11 Sponsor Protocol Number: SteP-on Start Date*: 2021-04-22
    Sponsor Name:OSPEDALE SANTA MARIA DELLA MISERICORDIA
    Full Title: A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients
    Medical condition: • Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD • A Modified Hoehn and Yahr stage of = 4 in the “off” state; • A stable (4 weeks since last modification)...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-002426-20 Sponsor Protocol Number: Z7219M01 Start Date*: 2018-10-19
    Sponsor Name:Zambon SpA
    Full Title: A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with mo...
    Medical condition: Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the “ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbid...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-017174-20 Sponsor Protocol Number: EMR701165_023 Start Date*: 2010-03-15
    Sponsor Name:Merck Serono S.A. - Geneva
    Full Title: A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering...
    Medical condition: Idiopathic Parkinson's disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2016-000973-19 Sponsor Protocol Number: SWH-MAOB Start Date*: Information not available in EudraCT
    Sponsor Name:IRCCS SAN RAFFAELE PISANA GESTITO DA SAN RAFFAELE ROMA SRL
    Full Title: OVERNIGHT SWITCH FROM RASAGILINE TO SAFINAMIDE IN FLUCTUATING PATIENTS WITH PARKINSON’S DISEASE: A TOLERABILITY AND SAFETY STUDY
    Medical condition: Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-020109-34 Sponsor Protocol Number: EMR701165-024 Start Date*: 2010-11-29
    Sponsor Name:Merck Serono S.A. - Geneva
    Full Title: Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes co...
    Medical condition: Cognition in non-demented patients with idiopathic Parkinson's disease Cognición en sujetos no dementes con Enfermedad de Parkinson idiopática
    Disease: Version SOC Term Classification Code Term Level
    12.1 10061536 Parkinson's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-005860-14 Sponsor Protocol Number: NW-1015/016/III/2006 Start Date*: 2006-12-19
    Sponsor Name:NEWRON PHARMACEUTICALS
    Full 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 idiopathi...
    Medical condition: PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE WITH MOTOR FLUCTUATIONS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061536 Parkinson's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-005861-21 Sponsor Protocol Number: NW-1015/018/III/2006 Start Date*: 2007-06-11
    Sponsor Name:NEWRON PHARMACEUTICALS
    Full Title: A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON TH...
    Medical condition: Patients with idiopathic Parkinson's disease with motor fluctuations
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000135-14 Sponsor Protocol Number: PXT-CL17-001 Start Date*: 2017-05-26
    Sponsor Name:Prexton Therapeutics B.V.
    Full Title: A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in ...
    Medical condition: Parkinson’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 02 04:20:41 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA