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Clinical trials for Closed Head Injury

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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
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    12 result(s) found for: Closed Head Injury. Displaying page 1 of 1.
    EudraCT Number: 2004-004921-89 Sponsor Protocol Number: 1315 Start Date*: 2005-05-25
    Sponsor Name:North Bristol NHS Trust
    Full Title: Improving diagnosis and treatment of attention deficits in head injured patients
    Medical condition: Attention difficulties after closed head injury
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-018283-16 Sponsor Protocol Number: BHR-100-301 Start Date*: 2010-09-24
    Sponsor Name:BHR Pharma, LLC
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients with Severe Traumatic Brain Injury
    Medical condition: Severe traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022117 - Injury, poisoning and procedural complications 10060690 Traumatic brain injury LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) GB (Completed) CZ (Completed) NL (Completed) AT (Completed) DE (Completed) ES (Completed) IT (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-014545-83 Sponsor Protocol Number: C10953/3067/ES/MN Start Date*: 2010-02-24
    Sponsor Name:Cephalon Inc.
    Full Title: A 12-week, randomized, double-blind, placebo-controlled, parallel-group. fixed-dosage study to evaluate the efficacy and safety of armodafinil (50, 150, and 250 mg/day) as treatment for patients wi...
    Medical condition: Patients with excessive Sleepiness associated with mild or moderate closed Traumatic Brain Injury (TBI)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10060690 Traumatic brain injury LLT
    12.0 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended) FR (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-001409-40 Sponsor Protocol Number: S334.2.002 Start Date*: 2009-03-04
    Sponsor Name:Solvay Pharmaceuticals B.V.
    Full Title: A Randomized, Double blind, Placebo-Controlled Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple Doses of SLV334 in Sequential Cohorts of Patients with ...
    Medical condition: Moderate and severe Traumatic Brain Injury (TBI)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060690 Traumatic brain injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-014544-11 Sponsor Protocol Number: C10953/3069/ES/MN Start Date*: 2010-05-21
    Sponsor Name:Cephalon Inc
    Full Title: Estudio abierto de 12 meses para la evaluación de la seguridad, la tolerabilidad y la eficacia de armodafinil (150 mg/día y 250 mg/día) como tratamiento para pacientes con somnolencia excesiva asoc...
    Medical condition: Pacientes con somnolencia excesiva asociada a un trauma craneo-cerebral no penetrante leve o moderado. Excessive sleepiness accociated with mild or moderate closed traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    12.0 10060690 Traumatic brain injury LLT
    12.0 10015595 Excessive daytime sleepiness LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-000301-40 Sponsor Protocol Number: 009531 Start Date*: 2016-03-11
    Sponsor Name:Queen Mary University of London
    Full Title: A randomised, blinded, placebo-controlled Phase 2a study to evaluate the safety and efficacy of Artesunate treatment in severely injured trauma patients with traumatic haemorrhage.
    Medical condition: Organ Dysfunction and Failure in Traumatic Hemorrhage
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-000219-14 Sponsor Protocol Number: 1957 Start Date*: 2008-03-19
    Sponsor Name:North Bristol NHS Trust
    Full Title: Efficacy of 8.4% sodium bicarbonate in adult patients with closed head injuries and intracranial hypertension.
    Medical condition: Raised intracranial pressure after severe head injury.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10022764 Intracranial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-005587-26 Sponsor Protocol Number: AM-101-CL-12-01 Start Date*: 2014-05-27
    Sponsor Name:Auris Medical Inc.
    Full Title: Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2 (TACTT2)
    Medical condition: Acute peripheral tinnitus following traumatic cochlear injury or otitis media
    Disease: Version SOC Term Classification Code Term Level
    18.0 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-004099-20 Sponsor Protocol Number: AM-101-CL-12-02 Start Date*: 2013-10-30
    Sponsor Name:Auris Medical AG
    Full Title: Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3 (TACTT3)
    Medical condition: acute peripheral tinnitus following traumatic cochlear injury or otitis media
    Disease: Version SOC Term Classification Code Term Level
    18.1 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed) DE (Completed) AT (Completed) GB (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-005588-24 Sponsor Protocol Number: AM-101-CL-12-03 Start Date*: 2014-05-27
    Sponsor Name:Auris Medical Inc.
    Full Title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) – an open-label extension to the TACTT2 study
    Medical condition: Treatment of peripheral tinnitus following traumatic cochlear injury or otitis media
    Disease: Version SOC Term Classification Code Term Level
    19.0 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-001527-39 Sponsor Protocol Number: AM-101-CL-12-04 Start Date*: 2013-11-21
    Sponsor Name:Auris Medical AG
    Full Title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) – an open-label extension to the TACTT3 study
    Medical condition: Treatment of peripheral tinnitus following traumatic cochlear injury or otitis media
    Disease: Version SOC Term Classification Code Term Level
    19.0 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed) DE (Completed) AT (Completed) GB (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-002502-74 Sponsor Protocol Number: NEU-01-02-01 Start Date*: 2012-02-14
    Sponsor Name:Neurophyxia B.V.
    Full Title: A multi-centre, randomised, double-blind, placebo-controlled Phase II study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of 2-iminobiotin (2-IB) in neonates with gestational...
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10004943 Birth asphyxia LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003500 Asphyxia neonatal LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
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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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