Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Botulinum toxin A injection

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   44338   clinical trials with a EudraCT protocol, of which   7368   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    263 result(s) found for: Botulinum toxin A injection. Displaying page 8 of 14.
    EudraCT Number: 2014-005114-33 Sponsor Protocol Number: s57283 Start Date*: 2015-03-10
    Sponsor Name:UZ Leuven
    Full Title: Effectiveness of Botulinum Toxin Infiltration for treatment of upper limb dysfunctions after treatment for breast cancer
    Medical condition: The aim of this study is to examine the effect of Botolinum Toxine infiltration in the pectoral muscle, in combination with an individual physical therapy programme, on pain and upper limb dysfunct...
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-003036-30 Sponsor Protocol Number: MRZ 60201-0607/1 Start Date*: 2007-03-08
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Ensaio clínico prospectivo, randomizado, de observador cego, com grupos paralelos e multicêntrico, para avaliar a eficácia e a segurança de duas diluições diferentes de NT 201 em pacientes com espa...
    Medical condition: Chronic upper limb spasticity caused by diverse etiologies
    Disease: Version SOC Term Classification Code Term Level
    9.0 10028335 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) DE (Completed) GB (Completed) AT (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-000901-77 Sponsor Protocol Number: A/220/05 Start Date*: 2007-07-12
    Sponsor Name:POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    Full Title: Treatment of sialorrhoea with botulinum toxin in patients with neurodegenerative diseases
    Medical condition: sialorrhoea in patients with neurodegenerative diseases
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039424 Salivary hypersecretion LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004399-68 Sponsor Protocol Number: 1925-201-008 Start Date*: 2019-03-29
    Sponsor Name:Allergan Ltd.
    Full Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN 151607) Injections into the Epicardial F...
    Medical condition: Post-operative atrial fibrillation (POAF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Completed) AT (Completed) SE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-012431-15 Sponsor Protocol Number: KNL:URO-2009/1 Start Date*: 2010-01-21
    Sponsor Name:Krajská nemocnice Liberec, a.s.
    Full Title: Možnosti terapeutického ovlivnění neurogenního hyperaktivního detruzoru u pacientů po spinálním poranění a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevřená studie porovná...
    Medical condition: Studie se zabývá léčbou hyperaktivního neurogeního detruzoru u pacientů, kteří trpí příznaky hyperaktivního močového měchýře jako důsledek spinálního poranění nebo roztroušené sklerózy. K léčbě se...
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001013-81 Sponsor Protocol Number: ProBaBle Start Date*: 2014-10-10
    Sponsor Name:Centro Hospitalar de São João, EPE
    Full Title: Treatment of Bladder Pain Syndrome with Onabotulinum toxin A
    Medical condition: Bladder Pain Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10071166 Bladder pain syndrome LLT
    Population Age: Adults Gender: Female
    Trial protocol: PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004834-42 Sponsor Protocol Number: 191622-057-02 Start Date*: 2006-09-11
    Sponsor Name:Allergan
    Full Title: A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Safety Study of Pulmonary Function in Patients with Reduced Lung Function Treated with BOTOX® (Botulinum Toxin Type A) Purified Neur...
    Medical condition: Focal upper limb spasticity due to upper motor neuron syndrome including poststroke spasticity. (for the objective of this study patients must also have stable compromised baseline respiratory status)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10028335 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2021-006048-29 Sponsor Protocol Number: INjECT Start Date*: 2022-02-21
    Sponsor Name:AOU MATERDOMINI
    Full Title: BotulInum toxin type A for peripheral Neuropathic pain in subjEcts with Carpal Tunnel syndrome: a multicenter, randomized, double-blind, placebo-controlled study
    Medical condition: Peripheral neuropathic pain in subjects with carpal tunnel syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10007698 Carpel tunnel syndrome LLT
    20.0 100000004852 10077974 Peripheral neuropathic pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001318-39 Sponsor Protocol Number: UNIHHSkinQuality202000401 Start Date*: 2021-04-30
    Sponsor Name:Prof. Dr. Martina Kerscher, University of Hamburg
    Full Title: Skin perception after intradermal application of IncobotulinumtoxinA within upper and midface (Interventional Phase II)
    Medical condition: Skin perception after intradermal application of INCOBOTULINUMTOXIN A within upper and midface
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001296-23 Sponsor Protocol Number: 61409 Start Date*: 2019-06-03
    Sponsor Name:Radboudumc
    Full Title: The efficacy of botulinum toxin A injection in pelvic floor muscles in chronic pelvic pain patients: a double-blinded randomised controlled trial
    Medical condition: Patients with >6 months or recurrent episodes of abdomino-perineo-pelvic pain, hypersensitivity or discomfort often associated with elimination changes, and sexual dysfunction in the absence of org...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003068-47 Sponsor Protocol Number: UROBOTOX 1 Start Date*: 2005-09-22
    Sponsor Name:Region Skåne, Universitetssjukhuset i Lund, Urologiska kliniken
    Full Title: Behandling med botulinumtoxin vid neurogen blåsfunktionsstörning
    Medical condition: The trial addresses patients with severe symptoms of neurogenic detrusor overactivity (urgency and/or urge incontinence). Eligible are those patients who have failed conservative treatment such as ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-002999-34 Sponsor Protocol Number: Y-79-52120-126 Start Date*: 2007-12-04
    Sponsor Name:Ipsen Limited
    Full Title: A phase II, international, multi-centre, prospective, randomised, parallel-group, double-blind, dose-ranging, placebo-controlled, 12-week, princeps study to assess the efficacy and safety of a one ...
    Medical condition: Idiopathic overactive bladder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020853 Hypertonic bladder LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) NL (Prematurely Ended) BE (Completed) FR (Completed) CZ (Completed) IT (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-001988-24 Sponsor Protocol Number: M602011069 Start Date*: 2021-09-07
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, randomized, double-blind, placebo-controlled, parallel-group trial with an open-label period to investigate the efficacy and safety of NT201 in the unilateral and bilateral treatment o...
    Medical condition: Essential tremor [ET] of the upper limb [UL]
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10015496 Essential tremor PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-003770-16 Sponsor Protocol Number: MRZ60201_3100_1 Start Date*: 2015-04-16
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: A prospective, open-label, multicenter, repeat-dose trial to investigate the safety and efficacy of NT 201 (incobotulinumtoxinA) in the combined treatment of upper facial lines (horizontal forehead...
    Medical condition: Upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral periorbital lines)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10040785 - Skin and subcutaneous tissue disorders 10040954 Skin wrinkling PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-019102-17 Sponsor Protocol Number: Y-55-52120-147 Start Date*: Information not available in EudraCT
    Sponsor Name:Ipsen Pharma SAS
    Full Title: A PHASE III, PROSPECTIVE, MULTICENTRE, OPEN LABEL, EXTENSION STUDY ASSESSING THE LONG TERM SAFETY AND EFFICACY OF REPEATED TREATMENT WITH DYSPORT USED IN THE TREATMENT OF LOWER LIMB SPASTICITY IN C...
    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 (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-005632-32 Sponsor Protocol Number: 2008TOXINA Start Date*: 2009-08-18
    Sponsor Name:Fundació privada de l'Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Full Title: INYECCIÓN FRECUENTE DE TOXINA BOTULÍNICA SIN PROTEÍNAS COMPLEJANTES: EVALUACIÓN DEL EFECTO SOBRE EL DOLOR EN DISTONÍA CERVICAL
    Medical condition: Distonía Cervical
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064124 Cervical dystonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003481-41 Sponsor Protocol Number: CPH-201-201461 Start Date*: 2020-01-17
    Sponsor Name:Croma-Pharma GmbH
    Full Title: A Double-Blinded Randomized Controlled Study to Compare the Efficacy, Time to Onset, and Duration of Effect of Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines
    Medical condition: moderate to severe glabellar frown lines at maximum frown
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10052609 Glabellar frown lines LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003841-86 Sponsor Protocol Number: Y-52-52120-214 Start Date*: 2015-04-30
    Sponsor Name:Ipsen Innovation
    Full Title: A phase III, randomised, double blind, placebo controlled and open label phase, multicentre study to investigate the efficacy and safety of BTX-A-HAC NG in the treatment of moderate to severe glabe...
    Medical condition: Moderate to severe Glabellar lines
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004858 10052609 Glabellar frown lines LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-000507-44 Sponsor Protocol Number: D-FR-52120-223 Start Date*: 2016-06-29
    Sponsor Name:Ipsen Innovation
    Full Title: A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT...
    Medical condition: Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10046543 Urinary incontinence PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) FR (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2012-005054-30 Sponsor Protocol Number: MRZ60201_3070_1 Start Date*: 2013-04-08
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, multicenter, randomized, double-blind, parallel-group, dose-response study of three doses Xeomin® (incobotulinumtoxinA, NT 201) for the treatment of lower limb spasticity in children a...
    Medical condition: Lower limb spasticity due to cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10058977 Spastic paresis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed) AT (Completed) DE (Completed) SK (Completed) CZ (Completed) ES (Completed) Outside EU/EEA FR (Ongoing)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 27 21:19:53 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA