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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
  • 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   44349   clinical trials with a EudraCT protocol, of which   7376   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 6 of 14.
    EudraCT Number: 2005-001794-10 Sponsor Protocol Number: Y-97-52120-727 Start Date*: 2006-05-17
    Sponsor Name:Ipsen Ltd
    Full Title: A Phase IV, Randomised, Double-blind, Dose-ranging, Study in Children and Young People to determine the Optimal Dose of Botulinum Toxin Type-A (Dysport®) in Managing the Symptoms of Hip Muscle Spas...
    Medical condition: Chronic Hip Pain due to Cerebral Palsy
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-017709-12 Sponsor Protocol Number: Y-55-52120-141 Start Date*: Information not available in EudraCT
    Sponsor Name:Ipsen Pharma SAS
    Full Title: A PHASE III, MULTICENTRE, DOUBLE BLIND, PROSPECTIVE, RANDOMISED, PLACEBO CONTROLLED STUDY ASSESSING THE EFFICACY AND SAFETY OF DYSPORT USED IN THE TREATMENT OF LOWER LIMB SPASTICITY IN CHILDREN WIT...
    Medical condition: Lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10024132 Leg spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-001815-38 Sponsor Protocol Number: 191622-143 Start Date*: 2014-12-16
    Sponsor Name:Allergan Limited
    Full Title: Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canth...
    Medical condition: Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004858 10048043 Wrinkling LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004530-16 Sponsor Protocol Number: 191622-090 Start Date*: 2008-02-27
    Sponsor Name:Allergan, Ltd.
    Full Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Single Treatment Cycle, Parallel Evaluation of the Safety, Efficacy and Immunogenicity of Two Formulations of BOTOX® (Botulinum Toxin Ty...
    Medical condition: Cervical dystonia: cervical dystonia that have never received treatment with botulinum toxin of any serotype for cervical dystonia or for any other indication
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) GB (Completed) PT (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002321-34 Sponsor Protocol Number: Y-52-52120-189 Start Date*: 2014-12-04
    Sponsor Name:Ipsen Innovation
    Full Title: A phase III, double blind, randomised, placebo controlled study to assess the efficacy and safety of a single treatment of Clostridium botulinum toxin type A to improve the appearance of moderate t...
    Medical condition: Moderate to severe Glabellar lines
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004858 10052609 Glabellar frown lines LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (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: 2022-000259-35 Sponsor Protocol Number: 2020_03 Start Date*: 2022-04-29
    Sponsor Name:Centre Hospitalier Universitaire de Lille
    Full Title: Assessment of the interest of a peri-operative antibiotic strategy applied to patients with asymptomatic bacteriuria undergoing intra-vesical botulinum toxin A injections
    Medical condition: Overactive bladder (OAB) and/or detrusor overactivity (DO) in multiple sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000554-38 Sponsor Protocol Number: D-FR-52120-221 Start Date*: 2015-07-24
    Sponsor Name:Ipsen Innovation
    Full Title: A Phase III, Multicenter, Double Blind, Randomised, Placebo Controlled Study to Assess the Efficacy and the Safety of a Single Cycle of Dysport Solution in the Treatment of Upper Limb Spasticity in...
    Medical condition: upper limb spastic hemiparesis due to stroke
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10058978 Spastic hemiparesis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000161-32 Sponsor Protocol Number: CLIN-52120-452 Start Date*: 2021-08-11
    Sponsor Name:Ipsen Pharma
    Full Title: A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison with Onabotulinu...
    Medical condition: upper limb spasticity (ULS) of any aetiology (in US and France) or post-stroke ULS (in Canada)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-009216-53 Sponsor Protocol Number: 191622-094 Start Date*: 2009-04-04
    Sponsor Name:Allergan Ltd
    Full Title: A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Ne...
    Medical condition: Urinary incontinence due to neurogenic detrusor overactivity
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029279 Neurogenic bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) NL (Completed) GB (Completed) FR (Completed) DE (Completed) IT (Completed) ES (Completed) BE (Completed) AT (Completed) CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2010-023240-33 Sponsor Protocol Number: POPPIES Start Date*: 2011-04-21
    Sponsor Name:Guys and St Thomas' NHS Foundation Trust
    Full Title: Post-operative pain in children with cerebral palsy following major hip surgery: a double blind randomised placebo controlled trial of pre-operative Botulinum toxin type A. [The Post-Operative Pain...
    Medical condition: Post Operative Pain in Cerebral Palsy
    Disease: Version SOC Term Classification Code Term Level
    10054710 Post Operative Hip Pain LLT
    10008129 Cerebral Palsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-002175-40 Sponsor Protocol Number: no number Start Date*: 2008-12-17
    Sponsor Name:
    Full Title: Effect of Botulinum Toxin A Injections and Specific Intensive Rehabilitation Therapy in Children with Hemiparetic Cerebral Palsy on Upper Limb Functions and Skills
    Medical condition: Study design: a factorial design with four study groups in which btA alone, intensive rehabilitation therapy aimed at improving bimanual skills alone, a combination of these two and continuing the ...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004682-32 Sponsor Protocol Number: 2011-09 Start Date*: 2012-02-07
    Sponsor Name:FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO
    Full Title: Intra-articular injection of botulinum toxin type A in hemiplegic shoulder pain: a multicentric, double blind randomised, versus steroid study.
    Medical condition: hemiplegic shoulder pain
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10028395 Musculoskeletal and connective tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004890-25 Sponsor Protocol Number: BOLD01 Start Date*: 2013-01-14
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA S. MARIA DELLA MISERICORDIA DI UDINE
    Full Title: Botulinum Toxin Serotype A randomized double-blind, placebo controlled multicentre study for degenerative coxarthrosis.
    Medical condition: coxarthrosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10028395 Musculoskeletal and connective tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-004821-26 Sponsor Protocol Number: MRZ60201_3074_1 Start Date*: 2013-04-01
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, double-blind, placebo-controlled, randomized, parallel-group, multi-center study with an open-label extension period to investigate the efficacy and safety of two different doses of NT...
    Medical condition: Bilateral Blepharospasm (BEB)
    Disease: Version SOC Term Classification Code Term Level
    15.1 10015919 - Eye disorders 10005159 Blepharospasm PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
    EudraCT Number: 2014-001860-36 Sponsor Protocol Number: 191622-142 Start Date*: 2014-12-19
    Sponsor Name:Allergan Limited
    Full Title: Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Forehead and Glabellar Facial Rhytides
    Medical condition: Facial Rhytides (Forehead Lines, Glabellar Lines)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004858 10048043 Wrinkling LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000575-32 Sponsor Protocol Number: 1 Start Date*: 2018-12-18
    Sponsor Name:Isabel Maria Ruiz
    Full Title: Results of the injection of botulinum toxin vs platelet rich plasma for the treatment of plantar fasciitis
    Medical condition: Plantar fasciitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10035155 Plantar fasciitis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003939-38 Sponsor Protocol Number: P160404J Start Date*: 2017-12-19
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Short-term efficacy of a single ultrasound-guided intra-articular injection of botulinum toxin A associated with splinting for base-of-thumb osteoarthritis on pain at 3 months: A randomized placebo...
    Medical condition: Patients referred to our Physical Medicine Rehabilitation Department of a tertiary care center in Paris, France, for the management of Base-of-thumb osteoarthritis (BTOA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10062893 Rhizarthrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000375-25 Sponsor Protocol Number: BotA-KKDS2016 Start Date*: 2016-04-19
    Sponsor Name:Danderyds sjukhus AB
    Full Title: Double blind placebo-controlled RCT of the efficacy and safety of intramuscular injections of Botulinum Toxin A as a treatment for provoked vestibulodynia
    Medical condition: Provoked vestibulodynia
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002541-11 Sponsor Protocol Number: P170912J Start Date*: 2019-06-06
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Prevention of post-operative Atrial Fibrillation by BOTulinum toxin injections into epicardial fat pads around pulmonary veins in patients undergoing cardiac surgery
    Medical condition: Adult patients with indication for conventional cardiac surgery (CABG, aortic replacement, or ascending aorta surgery) will be eligible
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004865 10067824 Prophylaxis against atrial fibrillation LLT
    Population Age: Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    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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