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Clinical trials for System safety

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   44336   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.
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    7,065 result(s) found for: System safety. Displaying page 1 of 354.
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    EudraCT Number: 2004-001590-26 Sponsor Protocol Number: MAS QUE NADA Start Date*: 2004-09-15
    Sponsor Name:OSPEDALE S. RAFFAELE
    Full Title: NATIONAL, MULTICENTER, RANDOMIZED,OPEN STUDY TO EVALUATE EFFICACY AND SAFETY OF LAMIVUDINE (300 MG QD) MONOTHERAPY AS AN ALTERNATIVE TO THERAPEUTIC INTERRUPTION IN PAZIENTS AFFECTED BY HIV-1, IN VI...
    Medical condition: HIV MONOTHERAPY TREATMENT , AS THERAPEUTIC MAINTENANCE, DURING INTERRUPTION OF ANTIVIRAL THERAPY
    Disease: Version SOC Term Classification Code Term Level
    6.1 10021428 SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-024270-19 Sponsor Protocol Number: CCD-1014-PR-0053 Start Date*: 2011-05-09
    Sponsor Name:CHIESI
    Full Title: A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/day for up to 12 Weeks) and to Explore the Eff...
    Medical condition: Mild Cognitive Impairment
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001881-14 Sponsor Protocol Number: GIFT/1 Start Date*: 2013-03-01
    Sponsor Name:AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    Full Title: A phase II clinical trial to evaluate the safety and efficacy of interferon gamma in elevating frataxin levels in Friedreich ataxia patients
    Medical condition: Friedreich's Ataxia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002627-10 Sponsor Protocol Number: RILUMEX Start Date*: 2015-11-03
    Sponsor Name:FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
    Full Title: A randomized, double-blind, controlled, monocenter, pivotal phase IIb study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN...
    Medical condition: NDM patients with mutations in SCN4A or CLCN1 gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002217-34 Sponsor Protocol Number: FITO-01/21 Start Date*: 2022-07-26
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI
    Full Title: Tuscany project to investigate on efficacy and safety of Cannabis phytotherapic preparations for the treatment of Aromatase iNhibitor-induced chronic resistaNt pAin in Breast cancer patIents: a pro...
    Medical condition: Aromatase iNhibitor-induced chronic resistaNt pAin in Breast cancer patIents
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-000770-60 Sponsor Protocol Number: CFTY720DIT03 Start Date*: 2011-04-12
    Sponsor Name:NOVARTIS FARMA
    Full Title: “An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists”
    Medical condition: approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-004084-66 Sponsor Protocol Number: om 112 Start Date*: 2002-07-09
    Sponsor Name:OSPEDALE ONCOLOGICO DI BARI
    Full Title: A phase II study on the efficacy and safety of topotecan in the treatment of patients with brain metastases
    Medical condition: Brain metastases
    Disease: Version SOC Term Classification Code Term Level
    6.1 10061287 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-001682-41 Sponsor Protocol Number: HLS03/2011 Start Date*: 2011-05-09
    Sponsor Name:AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
    Full Title: Comparison of the efficacy and the safety of different schedules of administration of sub-lingual immunotherapy in patients with ragweed pollinosis: a phase III randomized and controlled clinical s...
    Medical condition: Subjects who are allergic to Ragweed.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021428 - Immune system disorders 10021428 Immune system disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-000361-11 Sponsor Protocol Number: RD639/24201 Start Date*: 2006-06-23
    Sponsor Name:Fujimoto Pharmaceutical Corporation
    Full Title: A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients
    Medical condition: Treatment of Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    8.0 10029205
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-005749-30 Sponsor Protocol Number: 2015-00887 Start Date*: 2016-06-23
    Sponsor Name:Karolinska Institutet
    Full Title: A randomized, doubleblind, placebo-controlled multicenter trial to evaluate the safety and efficacy of rituximab (Mabthera) in subjects with new onset myasthenia gravis; the RINOMAX study
    Medical condition: New onset myasthenia gravis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000282-37 Sponsor Protocol Number: AIFA-2016-02365063 Start Date*: 2020-02-26
    Sponsor Name:DIPARTIMENTO DI NEUROSCIENZE SALUTE MENTALE E ORGANI DI SENSO - NESMOS - SAPIENZA UNIVERSITÀ DI ROMA
    Full Title: Riluzole (Glentek) in patients with SpinoCerebellar Ataxia type 7: a randomized, double-blind, placebo-controlled pilot trial with a lead in phase
    Medical condition: Spinocerebellar ataxia type 7 (SCA7)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-003034-42 Sponsor Protocol Number: ALX0061-C203 Start Date*: 2015-05-08
    Sponsor Name:Ablynx NV
    Full Title: A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed O...
    Medical condition: Rheumatoid Arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021428 - Immune system disorders 10021428 Immune system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) ES (Completed) BG (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-017412-32 Sponsor Protocol Number: NEURO1 Start Date*: 2011-12-13
    Sponsor Name:AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
    Full Title: RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE
    Medical condition: Parkinson disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013363 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2023-000604-19 Sponsor Protocol Number: R2810-ONC-1690 Start Date*: 2023-08-30
    Sponsor Name:Regeneron Pharmaceuticals Inc.
    Full Title: A Safety and Pharmacokinetic Study of Single Agent REGN2810 in Pediatric Patients with Relapsed or Refractory Solid or Central Nervous System (CNS) Tumors and a Safety and Efficacy Trial of REGN281...
    Medical condition: Relapsed Solid Tumor Refractory Solid Tumor Relapsed Central Nervous System Tumor Refractory Central Nervous System Tumor Diffuse Intrinsic Pontine Glioma High Grade Glioma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007958 Central nervous system neoplasm PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-020319-34 Sponsor Protocol Number: DGD 44-050 Start Date*: 2010-09-30
    Sponsor Name:GUERBET
    Full Title: SAFETY AND EFFICACY EVALUATION OF DOTAREM® IN MAGNETIC RESONANCE IMAGING (MRI) IN PATIENTS WITH CENTRAL NERVOUS SYSTEM (CNS) LESIONS
    Medical condition: Patient with Central Nervous System (CNS) Lesions
    Disease: Version SOC Term Classification Code Term Level
    12.1 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) ES (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-001587-30 Sponsor Protocol Number: GU11SU387 Start Date*: 2013-09-26
    Sponsor Name:NHS Greater Glasgow and Clyde
    Full Title: The role of pre-emptive analgesia with Qutenza (topical capsaicin 8%) in preventing neuropathic pain following lower limb amputation: a pilot randomised controlled study
    Medical condition: Chronic neuropathic pain following limb amputation
    Disease: Version SOC Term Classification Code Term Level
    16.0 10029205 - Nervous system disorders 10054095 Neuropathic pain LLT
    16.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-003697-27 Sponsor Protocol Number: CS2/713 Start Date*: 2020-05-04
    Sponsor Name:AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO
    Full Title: Effect of inhalatory sedation on cerebral perfusion in subarchnoid hemorrhage
    Medical condition: Patients with non traumatic subarachnoid hemorrhage (WFNS = 3 -5)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002257-28 Sponsor Protocol Number: 2021-002257-28 Start Date*: 2021-11-09
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA UDINE
    Full Title: Randomised controlled trial to evaluate the efficacy of local anaesthetic application in spray for the repair of 1st- 2nd perineal lacerations following vaginal delivery
    Medical condition: Considering the high percentage of grade 1 and 2 perineal lacerations, it is evident that another route of administration of the anaesthetic could be of great help in further reducing the discomfor...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10021428 Immune system disorders SOC
    Population Age: Adults Gender: Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-019421-33 Sponsor Protocol Number: 183/10 Start Date*: 2012-10-31
    Sponsor Name:POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    Full Title: Plasma sostitution in paediatric neurosurgery: comparison between two sinthetic colloids: HES 130/0,42/6:1 in normal salin solution (Voluven)vs HES 130/0,42/6:1 in balanced electrolitic solution (p...
    Medical condition: pediatric patients undergoing major neurosurgical procedures
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016066-91 Sponsor Protocol Number: EPO200901 Start Date*: 2010-03-10
    Sponsor Name:ISTITUTO NEUROLOGICO "CARLO BESTA"
    Full Title: SAFETY AND EFFICACY OF ERYTHROPOIETIN IN AMYOTROPHIC LATERAL SCLEROSIS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL
    Medical condition: ALS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029205 SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
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    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.

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