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Clinical trials for Drooling

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    14 result(s) found for: Drooling. Displaying page 1 of 1.
    EudraCT Number: 2013-000863-94 Sponsor Protocol Number: 6474 Start Date*: 2013-08-29
    Sponsor Name:Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: A single blind study comparing the efficacy of Glycopyrronium and Hyoscine on drooling in children with neurodisability - DRI Trial (Drooling Reduction Intervention)
    Medical condition: Excessive drooling in children with non-progressive neurodisability
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10013642 Drooling PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-004057-23 Sponsor Protocol Number: 2021-12945 Start Date*: 2022-02-28
    Sponsor Name:Radboudumc
    Full Title: Ethanol submandibular duct ligation for drooling in children with neurodisabilities
    Medical condition: Drooling or sialorrhea
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-000095-10 Sponsor Protocol Number: 69HCL18_0235 Start Date*: 2021-07-20
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Evaluation of the long-term efficacy of the injection of botulinum toxin A into the salivary glands versus scopolamine patches in the treatment of drooling in children over 4 years old with cerebra...
    Medical condition: Children with cerebral palsy aged 4 years old and over, presenting a pathological drooling
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10008129 Cerebral palsy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-003017-14 Sponsor Protocol Number: 132998 Start Date*: 2008-01-08
    Sponsor Name:Käkkliniken, Universitetssjukhuset i Linköping
    Full Title: A comparison of the effect of Atropine and Botulinum-toxin in patients with severe drooling
    Medical condition: Patients with ALS, Parkinson´s disease, brain-damage cerebral paralysis or other neurological conditions often have an impaired swallowing, resulting in drooling. This adds a social handicap and o...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005534-15 Sponsor Protocol Number: PRO-GLY-002/E2013 Start Date*: 2021-04-01
    Sponsor Name:Proveca Pharma LTD
    Full Title: Double-blind, placebo-controlled, randomized clinical trial comparing the efficacy and safety of Sialanar plus oral rehabilitation against placebo plus oral rehabilitation for children and adolesce...
    Medical condition: Severe sialorrhoea and neurodisabilties in children
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021691-28 Sponsor Protocol Number: DAMS-7 Start Date*: 2011-11-04
    Sponsor Name:Hospital Vall d'Hebron
    Full Title: PILOT CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF BOTULINUM NEUROTOXIN TYPE- A IN SALIVARY GLANDS IN THE TREATMENT OF CHRONIC DROOLING IN PATIENTS WITH CEREBRAL PALSY: A CONTROLLED CLINIC...
    Medical condition: Hypersalivation (chronic sialorrhea)in patients with cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10039424 Salivary hypersecretion PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004532-30 Sponsor Protocol Number: MRZ60201_3091_1 Start Date*: 2014-12-09
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of...
    Medical condition: Chronic troublesome sialorrhea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in children and adolescents
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10039424 Salivary hypersecretion PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) Outside EU/EEA
    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: 2014-001631-36 Sponsor Protocol Number: CPL061-01 Start Date*: 2015-02-02
    Sponsor Name:Colonis Pharma Limited
    Full Title: A Double-blind, Randomised, Placebo Controlled Study of the Efficacy of Glycopyrronium bromide 1mg /5ml in the Treatment of Non-drug Induced Hypersalivation with an Open Single-arm Extension to Inv...
    Medical condition: Neurodevelopmental disability associated with hypersalivation
    Disease: Version SOC Term Classification Code Term Level
    17.1 10037175 - Psychiatric disorders 10064062 Neurodevelopmental disorder PT
    17.1 100000004856 10020746 Hypersalivation LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002299-15 Sponsor Protocol Number: FIO11-05 Start Date*: 2012-10-03
    Sponsor Name:Universitair Medisch Centrum Utrecht
    Full Title: The effect of glycopyrroniumbromide on nocturnal clozapine induced sialorrhea in psychiatric patients: a randomized, cross-over, double blind, placebo controlled trial with an extended open label p...
    Medical condition: Nocturnal sialorrhea caused by the use of clozapine
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-002557-30 Sponsor Protocol Number: PRO/GLY/001 Start Date*: 2014-03-18
    Sponsor Name:Proveca Ltd
    Full Title: A two-staged, open label, single dose, two period, two-sequence, crossover study to compare the bioavailability of 2 mg Glycopyrronium Bromide from a new oral solution (2 mg/5 ml) (Test Product) wi...
    Medical condition: Sialorrhoea (chronic pathological drooling)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2012-005539-10 Sponsor Protocol Number: MRZ60201_3090_1 Start Date*: 2014-04-29
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter study, with an extension period of dose-blinded active treatment, to investigate the efficacy and safety of two...
    Medical condition: Chronic troublesome sialorrhea resulting from neurological conditions in adults with Parkinson's disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration or progressive ...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10017947 - Gastrointestinal disorders 10039424 Salivary hypersecretion PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000682-30 Sponsor Protocol Number: 01-09.02.15. Start Date*: 2015-04-27
    Sponsor Name:Tartu University Hospital
    Full Title: Botulinum neurotoxin type A treatment for sialorrhea in central nervous system diseases
    Medical condition: Hypersalivation
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004856 10020746 Hypersalivation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023161-21 Sponsor Protocol Number: 2010.607/11 Start Date*: 2011-11-23
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Evaluation de la toxine botulinique dans le traitement du trouble salivaire chez le patient atteint de sclérose latérale amyotrophique
    Medical condition: Sclérose Latérale Amyotrophique (SLA)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10002026 Amyotrophic lateral sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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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