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Clinical trials for Botulinum toxin

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
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    • 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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    265 result(s) found for: Botulinum toxin. Displaying page 2 of 14.
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    EudraCT Number: 2015-000162-59 Sponsor Protocol Number: PHRCN2014DURIF Start Date*: 2015-05-15
    Sponsor Name:CHU Clermont-Ferrand
    Full Title: Evaluation of botulinum toxin injection efficacy in the treatment of head essential tremor by a multi-center, randomized, double–blind, parallel-group, placebo-controlled study
    Medical condition:
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004650-93 Sponsor Protocol Number: botuline5 Start Date*: 2007-10-10
    Sponsor Name:University Medical Center Groningen
    Full Title: The effect of Botulinum toxin A injections for overactive bladder on detrusor contractility
    Medical condition: Neurogenic or idiopathic overactive bladder, not adequately responding to anticholinergic therapy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004636-66 Sponsor Protocol Number: KP-2011-0077 Start Date*: 2011-12-05
    Sponsor Name:Uppsala University Hospital
    Full Title: Single-blinded randomized trial of Botulinumtoxin A (Vistabel®) and its objective paralytic effect in the facial muscles of healthy women: development of new neurophysiological measurements.
    Medical condition: The treatment of glabellar lines in healthy women by muscle paralysis from injection of botulinum toxin
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-006169-15 Sponsor Protocol Number: ALLCD001 Start Date*: 2006-05-18
    Sponsor Name:Allergan Limited
    Full Title: A Double-Blind, Randomised, Cross-over, Safety and Efficacy Pilot Study Comparing Two Botulinum Toxin Type-A Products in the Treatment of Moderate to Severe Cervical Dystonia.
    Medical condition: Cervical dystonia is the most common form of focal dystonia prevalent at a rate of 89 per million individuals. Sustained involuntary contractions of the neck muscles, lead to painful and disabling ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-006170-10 Sponsor Protocol Number: ALLBL001 Start Date*: 2006-06-22
    Sponsor Name:Allergan Limited
    Full Title: A Double-Blind, Randomised, Parallel group, Safety and Efficacy Pilot Study Comparing Two Botulinum Toxin Type-A Products in the Treatment of Blepharospasm
    Medical condition: Blepharospasm is a focal dystonia characterised by excessive involuntary contraction of the orbicularis oculi muscles. In severe cases, tonic eyelid closure can lead to functional blindness and can...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-002981-39 Sponsor Protocol Number: v1.1aug05 Start Date*: 2008-09-19
    Sponsor Name:University Hospitals of Leicester NHS Trust
    Full Title: Randomised trial of detrusor botulinum toxin injection (BOTOX®) compared to placebo in women with idiopathic detrusor overactivity
    Medical condition: Detrusor overactivity which is a disease of bladder function where unprovoked contractions of the detrusor muscle are generated during the storage phase of micturition. Symptoms include frequency, ...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-004011-30 Sponsor Protocol Number: 987654321 Start Date*: 2005-12-02
    Sponsor Name:Gwent Healthcare NHS Trust
    Full Title: A prospective open study evaluating the use of botulinum toxin in patients with overactive bladder as an alternative to other conservative treatments.
    Medical condition: Overactive bladder syndrome is characterized by a combination of urinary frequency, urgency and urge incontinence.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-020057-13 Sponsor Protocol Number: 034-002 Start Date*: 2010-06-11
    Sponsor Name:Dermatologikum Hamburg
    Full Title: Proof-of-concept-study to Evaluate the Efficacy and Tolerability of Repeated Versus Single Treatment with Botulinum-Toxin (Vistabel®) Treatment in Combination with a Hyaluronic Acid (Juvederm-Ultra...
    Medical condition: moderate to severe glabellar frown lines
    Disease: Version SOC Term Classification Code Term Level
    12.1 10052609 Glabellar frown lines LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004637-17 Sponsor Protocol Number: 191622-080-00 Start Date*: 2006-04-04
    Sponsor Name:ALLERGAN LTD
    Full Title: A Multicenter Study Evaluating the Efficacy and Safety of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Migraine Patients with 15 or More Headache Days per ...
    Medical condition: Headache prophylaxis in migraine patients with 15 or more headache days per month
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-004646-42 Sponsor Protocol Number: 05PF1311 Start Date*: 2014-03-17
    Sponsor Name:Q-MED AB
    Full Title: A randomized, evaluator-blinded, comparative study to evaluate the efficacy and safety of different injection volumes of botulinum toxin type A, Azzalure®, in the glabellar lines.
    Medical condition: Glabella frown lines
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004858 10052609 Glabellar frown lines LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2022-003817-12 Sponsor Protocol Number: 2021/0384/HP Start Date*: 2023-05-15
    Sponsor Name:CHU de Rouen
    Full Title: Mechanisms of action on rectal motility of intrarectal botulinum toxin injections in patients with fecal incontinence
    Medical condition: Patients with fecal incontinence who have failed conservative treatments and are candidates for intrarectal botulinum toxin injections.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10016296 Fecal incontinence LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002929-36 Sponsor Protocol Number: TBFP2018 Start Date*: 2019-04-30
    Sponsor Name:Dra. Virginia Raquel Céspedes Nava
    Full Title: COMPARATIVE STUDY OF THE EFFICACY OF THE TREATMENT OF PLANTAR FASCITIS WITH INFILTRATION OF CORTICOIDS VS BOTULINIC TOXIN. ECOGRAPHIC FINDINGS
    Medical condition: Plantar fasciitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000842-14 Sponsor Protocol Number: TBCH2022 Start Date*: 2022-07-01
    Sponsor Name:Dra.Margarita Ramirez&Dra.Ifara Sánchez
    Full Title: Trial study to evaluate the effectiveness of botulinum toxin A (incobotulinumtoxin) injection in reducing the pain and size of painful scars (including hypertrophic and keloid scars)
    Medical condition: painful scars
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015125-36 Sponsor Protocol Number: NCT00934687 Start Date*: Information not available in EudraCT
    Sponsor Name:Medical School Hannover. Department of Psychiatry, Social Psychiatry and Psychotherapy
    Full Title: Clostridium botulinum Typ A Neurotoxinkomplex zur adjuvanten Behandlung von depressiven Störungen – Eine randomisierte, kontrollierte Pilotstudie
    Medical condition: Botulinum Toxin for the Treatment of Depression
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-000709-70 Sponsor Protocol Number: Y-47-52120-051 Start Date*: 2005-12-21
    Sponsor Name:Ipsen Ltd
    Full Title: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
    Medical condition: Cervical Dystonia (CD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-005194-27 Sponsor Protocol Number: 240672 Start Date*: 2005-03-09
    Sponsor Name:Department of Neurology, Medical University of Vienna
    Full Title: Anti-inflammatory and/or antinociceptive effects of botulinum toxin A in an experimental inflammatory human skin pain model: a randomised, double blinded, placebo controlled study
    Medical condition: not applicable In this trial a potential antinociceptive potency af the IMP (Dysport) will be testet i9n a human inflammatory pain model. The present study will only include heathy volunteers.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-009868-31 Sponsor Protocol Number: 80-82310-98-09088 Start Date*: 2009-06-18
    Sponsor Name:ZonMW
    Full Title: Quality of life, gross motor function, and actual everyday physical activity level in children with spastic Cerebral Palsy: (cost)effectiveness of combined treatment with multilevel botulinum-toxin...
    Medical condition: Spastic Cerebral Palsy, GMFCS levels I-III
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-005068-82 Sponsor Protocol Number: OZR-2012-07 Start Date*: 2013-04-08
    Sponsor Name:The Rotterdam Eye Hospital
    Full Title: An alternative approach for treatment of infantile esotropia with botulinum toxin A.
    Medical condition: infantile esotropia
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005653-24 Sponsor Protocol Number: IRB00003099 Start Date*: 2021-06-28
    Sponsor Name:Clínica Integral del pie-Ana Sans
    Full Title: Effectiveness of botulinum toxin infiltration in spasticity of the 1st toe in patients with neurological pathology
    Medical condition: The application of Botox is described in the technical sheet for spasticity and has already been applied to the foot. This is how we speak of a phase IV clinical trial, with a low level of interven...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-004858-33 Sponsor Protocol Number: Version 2.0 (03Nov2010) Start Date*: 2009-01-09
    Sponsor Name:University College London
    Full Title: Open label pilot study to treat women with chronic urinary retention or voiding dysfunction due to a primary disorder of sphincter relaxation (Fowler’s syndrome) with outpatient urethral sphincter ...
    Medical condition: Primary abnormality of the urethral sphincter or Fowlers Syndrome
    Disease: Version SOC Term Classification Code Term Level
    9.1 10046456 Urethral instrinsic sphincter deficiency LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    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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