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Clinical trials for Botulinum Toxin Type A

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   44343   clinical trials with a EudraCT protocol, of which   7372   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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    228 result(s) found for: Botulinum Toxin Type A. Displaying page 7 of 12.
    EudraCT Number: 2012-000248-91 Sponsor Protocol Number: BTACH2012 Start Date*: 2013-01-08
    Sponsor Name:Institutt for nevromedisin, NTNU
    Full Title: Endoscopic block of the sphenopalatine ganglion with botulinum toxin in intractable cluster headache. Safety issues.
    Medical condition: Pharmacological refractory cluster headache with durations of periods of attacks normally more than 2 months
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10009698 Cluster headaches LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (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: 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: 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: 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: 2014-003841-86 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: 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: 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: 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: 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: 2010-020828-21 Sponsor Protocol Number: 191622-099 Start Date*: Information not available in EudraCT
    Sponsor Name:Allergan Limited
    Full Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects with...
    Medical condition: Treatment of lateral canthal rhytides in the periorbital region (CFL)
    Disease: Version SOC Term Classification Code Term Level
    13.1 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: 2013-002896-17 Sponsor Protocol Number: V1.17.05.2013 Start Date*: Information not available in EudraCT
    Sponsor Name:Orthopädisches Spital Speising
    Full Title: Functional evaluation of two therapy concepts: dynamic orthoses and BoNT
    Medical condition: Infantile cerebral palsy
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001852-43 Sponsor Protocol Number: BTACM2014 Start Date*: 2014-08-11
    Sponsor Name:Department of Neuroscience, NTNU
    Full Title: Botulinum toxin type A block of the sphenopalatine ganglion in chronic migraine. Safety issues
    Medical condition: Chronic migraine
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004852 10066636 Chronic migraine LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: View results
    EudraCT Number: 2009-015868-34 Sponsor Protocol Number: Y-55-52120-140 Start Date*: 2011-02-15
    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 FOR THE TREATMENT OF LOWER LIMB SPASTICITY IN ADULT SUBJ...
    Medical condition: Leg Spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10024132 Leg spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) SK (Completed) IT (Completed) PT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2020-003623-42 Sponsor Protocol Number: D-FR-10200-001 Start Date*: 2021-02-17
    Sponsor Name:Ipsen Innovation
    Full Title: An Integrated Phase I/II, Multicentre, Double-Blind, Randomised, Dysport and Placebo-Controlled, Dose-Escalation and Dose-Finding Study to Evaluate the Safety and Efficacy of IPN10200 in the Treatm...
    Medical condition: Upper limb spasticity after stroke or traumatic brain injury.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10041416 Spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) HU (Trial now transitioned) BG (Trial now transitioned)
    Trial results: (No results available)
    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: 2010-018298-39 Sponsor Protocol Number: botox2010 Start Date*: 2010-02-15
    Sponsor Name:UZLeuven
    Full Title: Prospective Randomised Double-blind Sham Study on the Use of Botox for the Treatment of Diffuse esophageal spasm
    Medical condition: the effect of Botox on symptoms and manometry patterns in patients with diffuse esophageal spasm.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10015390 Esophageal spasm LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    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: 2010-019069-28 Sponsor Protocol Number: Y-52-52120-145 Start Date*: 2011-06-07
    Sponsor Name:Ipsen Innovation
    Full Title: A phase III, multicentre, prospective, double blind, randomised, placebo controlled study, assessing the efficacy and safety of Dysport intramuscular injections used for the treatment of upper limb...
    Medical condition: Arm Spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10048970 Arm spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) SK (Completed) PL (Completed) IT (Completed) HU (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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