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Clinical trials for Restlessness

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 ).  
     
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    29 result(s) found for: Restlessness. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-001466-10 Sponsor Protocol Number: MY-clonidin-1 Start Date*: 2014-10-10
    Sponsor Name:Copenhagen University Hospital, Rigshospitalet, Juliane Marie Centre, Department of Anaesthesiology
    Full Title: does intraoperative clonidine reduce postoperative agitation in children anaesthetized with sevofluran? A RCT including pharmacokinetic investigation
    Medical condition: postoperative agitation
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10056436 Psychomotor agitation LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2022-000943-59 Sponsor Protocol Number: 280482 Start Date*: 2022-12-22
    Sponsor Name:Odense University Hospital, anaeshtesiologic intensive ward V
    Full Title: Autonome-nervous system regulated anaesthesia: A randomized controlled trial comparing dexmedetomedine and placebo in heart rate variability monitored children
    Medical condition: Postoperative agitation
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10001499 Agitation mental LLT
    21.1 100000004852 10056436 Psychomotor agitation LLT
    20.1 100000004863 10079742 Agitation on recovery from sedation LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-001157-17 Sponsor Protocol Number: PSI-HAL-2014 Start Date*: 2014-07-29
    Sponsor Name:Fundació Parc Taulí
    Full Title: Efficacy and safety of intranasal administration of haloperidol in agitated schizophrenic patients: a controlled, blinded, randomized and single-center clinical trial
    Medical condition: Agitation in schizophrenic patients
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-003975-35 Sponsor Protocol Number: 750201.01.014 Start Date*: 2005-05-18
    Sponsor Name:Dr. Willmar Schwabe GmbH & Co. KG
    Full Title: Multi-center, double-blind, placebo-controlled, randomized phase III study to prove the efficacy, safety and tolerability of Lavender oil WS 1265 (Lavandula angustifolia) in patients with restlessn...
    Medical condition: restlessness and sleep disturbances MedDRA Code for RESTLESSNESS: 10038743 MedDRA Code für SLEEP DISTURBANCES: 10040997
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003331-36 Sponsor Protocol Number: FER-Loxapine-2015-01 Start Date*: 2016-03-16
    Sponsor Name:FERRER INTERNACIONAL SA
    Full Title: A Phase IV, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety of self-administered ADASUVE(R) (Staccato loxapine for inhalation) in Agitated Patients outside the hospital setting
    Medical condition: Mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2017-001339-38 Sponsor Protocol Number: 17-AVP-786-305 Start Date*: 2018-01-22
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-design study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/qui...
    Medical condition: Agitation Associated with Dementia of the Alzheimer's Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) FR (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-007384-17 Sponsor Protocol Number: 3005099 Start Date*: 2009-11-30
    Sponsor Name:Sten Walther
    Full Title: A prospective, multi-centre, randomised, double-blind, placebo-controlled comparison of intravenous dexmedetomidine with haloperidol in treatment of hyperactive delirium after heart surgery.
    Medical condition: Postoperative hyperactive delirium
    Disease: Version SOC Term Classification Code Term Level
    12.0 10000702 Acute delirium LLT
    12.0 10049989 Agitation postoperative LLT
    12.0 10056436 Psychomotor agitation LLT
    12.0 10049987 Confusion postoperative LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-002455-29 Sponsor Protocol Number: 15-AVP-786-303 Start Date*: 2018-07-31
    Sponsor Name:Avanir Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multicenter, Long-term, Extension Study of the Safety and Efficacy of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the Treatment of Agitation...
    Medical condition: Agitation Associated with Dementia of the Alzheimer's Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) FR (Completed) PL (Completed) BG (Completed) CZ (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001056-17 Sponsor Protocol Number: 3606 Start Date*: 2020-08-14
    Sponsor Name:Kings's College London [...]
    1. Kings's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: A randomised feasibility trial investigating Sativex® for the treatment of the Agitation & Aggression (A/A) in Alzheimer’s Dementia.
    Medical condition: Clinically significant agitation in Alzheimer's Diseases
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001499 Agitation mental LLT
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2012-004627-20 Sponsor Protocol Number: 176S11NB Start Date*: 2013-04-05
    Sponsor Name:Pascoe pharmazeutische Präparate GmbH
    Full Title: Randomized double-blind, placebo controlled study with NEURAPAS® balance in addition to psychoeducation or psychotherapy in adolescents from 12 to 17 years suffering from mild depressive episodes w...
    Medical condition: Mild depressive episodes with nervous restlessness
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10012402 Depressive episode LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-004789-36 Sponsor Protocol Number: 173-01 Start Date*: 2022-06-29
    Sponsor Name:Universität Heidelberg
    Full Title: Randomized, controlled trial of the use of intranasal midazolam for the treatment of terminal agitation in palliative care patients
    Medical condition: Terminal agitation in the final phase
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003942-32 Sponsor Protocol Number: NXEEG-05/01 Start Date*: 2005-12-12
    Sponsor Name:Biologische Heilmittel Heel GmbH
    Full Title:
    Medical condition: Sleep disturbances and nervous states of restlessness
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-002780-16 Sponsor Protocol Number: 8.4 Start Date*: 2012-06-11
    Sponsor Name:Karolinska Institutet
    Full Title: PROLOGUES - Prehospital lowering of glucose in Stroke
    Medical condition: Patients with hyperglycemia and symptoms of acute stroke will be randomized to either subcutaneous injection with 10ug of Byetta or standard care.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2011-006129-17 Sponsor Protocol Number: 178S11PF Start Date*: 2012-05-18
    Sponsor Name:PASCOE Pharmazeutische Präparate GmbH
    Full Title: A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora incarnata L. in an acute stressful situation
    Medical condition: Since only healthy volunteers will be included in this study, there is no medical condition to be examined. The indication for PASCOFLAIR® is nervous restlessness, a subclinical state of stress-sen...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-011112-37 Sponsor Protocol Number: 2009-3 Start Date*: 2009-08-04
    Sponsor Name:Dept. of Anaesthesia, Oslo University Hospital, Ullevål
    Full Title: Dexmedetomidine versus midazolam til sedasjon av pediatriske intensivpasienter ved Oslo Universitetssykehus.
    Medical condition: Paediatric patients requiring mecanical ventilation and sedation in PICU.
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002287-14 Sponsor Protocol Number: Reutelen Start Date*: 2016-12-23
    Sponsor Name:Erasmus MC Cancer Institute
    Full Title: Death rattle in the dying phase: is prophylactic treatment useful?
    Medical condition: Death rattle in the dying phase
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10031920 Other diseases of trachea and bronchus, not elsewhere classified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003541-17 Sponsor Protocol Number: FIMHCSBR-2017 Start Date*: 2018-10-24
    Sponsor Name:FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud [...]
    1. FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    2. APES Costa del Sol (Agencia Pública Empresarial Sanitaria)
    Full Title: Neuropsiquiatric Evolution After Introduction of Raltegravir QD in substitution of dolutegravir: NEAR QD Study
    Medical condition: Human Inmunodeficiency Virus Infection (HIV)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001101-14 Sponsor Protocol Number: 750253.01.030 Start Date*: 2016-03-09
    Sponsor Name:Dr. Willmar Schwabe GmbH & Co. KG
    Full Title: Driving fitness under acute and subchronic application of Silexan® (WS® 1265) in comparison to placebo and Lorazepam with healthy volunteers in two successive, randomized, double-blind, crossover d...
    Medical condition: Investigation in healthy volunteers. The investigational medicinal product has a marketing authorisation in Germany for the treatment of restlessness related to anxious mood.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-003941-42 Sponsor Protocol Number: B4Z-SO-LY15 Start Date*: 2005-02-11
    Sponsor Name:Eli Lilly Sweden AB
    Full Title: A Randomised, Double Blind Placebo Controlled Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Swedish Children and ...
    Medical condition: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common psychiatric disorder that has its onset in childhood, and that is estimated to occur in 3% to 6% of school-age children. ADHD is characte...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2013-000905-22 Sponsor Protocol Number: 5505 Start Date*: 2013-07-09
    Sponsor Name:Hôpitaux Universitaires de Strasbourg
    Full Title: à compléter
    Medical condition: akathisia
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029205 - Nervous system disorders 10001540 Akathisia PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed)
    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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