Botulinum Toxin ( DrugBank: - )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 12 |
| 13 | 多発性硬化症／視神経脊髄炎 | 35 |
| 149 | 片側痙攣・片麻痺・てんかん症候群 | 6 |
6. パーキンソン病
臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04277247 (ClinicalTrials.gov) | January 12, 2021 | 10/2/2020 | Botulinum Toxin Type A for Foot Dystonia-associated Pain in Parkinson's Disease | Botulinum Toxin A (Onabotulinumtoxin A) for Foot Dystonia-associated Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Control Study | Dystonia Disorder;Parkinson Disease | Drug: Botulinum toxin type A;Drug: Placebo | University of Calgary | Allergan | Recruiting | 30 Years | 100 Years | All | 40 | Phase 2/Phase 3 | Canada |
| 2 | ChiCTR-INR-17012013 | 2017-09-01 | 2017-07-17 | Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease | Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease | Parkinson‘s disease, Depression | BTX-A:BOTOX Allergan;Placebo:0.9% Sodium Chloride Injection; | Shanghai Tongji Hospital, Tongji University | NULL | Pending | 18 | 80 | Both | BTX-A:40;Placebo:40; | China | |
| 3 | NCT02668497 (ClinicalTrials.gov) | March 2016 | 26/1/2016 | Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy | Kinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A Therapy | Parkinson's Disease | Drug: Botulinum Toxin Type A | Western University, Canada | NULL | Active, not recruiting | 18 Years | 80 Years | All | 50 | Phase 2 | Canada |
| 4 | NCT02472210 (ClinicalTrials.gov) | July 2014 | 11/6/2015 | The Use of Botox in Advanced Parkinson's Patients Experiencing Pain | A Study of the Utility of Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease Double Blind Placebo Control Crossover Pilot Study | Parkinson's Disease | Drug: Botulinum Toxin | University Health Network, Toronto | NULL | Active, not recruiting | 18 Years | N/A | Both | 14 | Phase 4 | NULL |
| 5 | EUCTR2012-005539-10-DE (EUCTR) | 29/04/2014 | 18/12/2013 | Clinical study to investigate the efficacy and safety of two dose levels of NT 201 versus placebo in treating chronic troublesome sialorrhea in various neurological conditions. | 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 dose levels of NT 201 in treating chronic troublesome sialorrhea in various neurological conditions - SIAXI – Sialorrhea in Adults Xeomin Investigation | Chronic troublesome sialorrhea resulting from neurological conditions in adults with Parkinson's disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration or progressive supranuclear palsy), or after stroke or traumatic brain injury. MedDRA version: 18.1;Level: PT;Classification code 10039424;Term: Salivary hypersecretion;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xeomin INN or Proposed INN: NT 101 Other descriptive name: BOTULINUM TOXIN TYPE A Trade Name: Xeomin INN or Proposed INN: NT 101 Other descriptive name: BOTULINUM TOXIN TYPE A | Merz Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Poland;Germany | ||
| 6 | EUCTR2009-017412-32-IT (EUCTR) | 13/12/2011 | 27/04/2010 | RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND | RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND | Parkinson disease MedDRA version: 9.1;Level: LLT;Classification code 10013363 | Trade Name: BOTOX INN or Proposed INN: Botulinum toxin Trade Name: NEUROBLOC INN or Proposed INN: Botulinum toxin | AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 7 | NCT02427646 (ClinicalTrials.gov) | October 2011 | 22/4/2015 | Kinematic-guided BoNT-A Treatment for ET and PD Tremor | Use of Kinematic Assessment of Hand Tremor Pre- and Post- Treatment With Botulinum Toxin Type A in Essential Tremor and Parkinson Disease | Tremor | Drug: BoNT-A | Western University, Canada | NULL | Active, not recruiting | 18 Years | 80 Years | All | 54 | Phase 2 | NULL |
| 8 | NCT00909883 (ClinicalTrials.gov) | September 2009 | 19/5/2009 | Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles) | Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles) | Parkinson's Disease;Foot Dystonia | Drug: Botulinum Toxin: Xeomin;Drug: Placebo | University Hospital, Clermont-Ferrand | Merz Pharma France | Recruiting | 30 Years | 75 Years | Both | 45 | Phase 3 | France |
| 9 | NCT00767546 (ClinicalTrials.gov) | May 2009 | 5/10/2008 | Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients | Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients | Parkinson Disease;Parkinsonism;Seborrheic Dermatitis | Drug: Botulinum toxin | Rabin Medical Center | NULL | Not yet recruiting | 18 Years | N/A | Both | 40 | Phase 1 | NULL |
| 10 | NCT01421719 (ClinicalTrials.gov) | February 2009 | 19/8/2011 | Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's Disease | Onabotulinum Toxin Type A (BTX-A) For Treatment of Neurogenic Overactive Bladder Due to Parkinson's Disease: Safety and Efficacy | Parkinson's Disease;Neurogenic Bladder;Urinary Incontinence;Clostridium Botulinum Toxin Adverse Reaction | Drug: Cystoscopic injection of Botox into the urinary bladder | Stanford University | Allergan | Completed | 50 Years | 85 Years | All | 20 | Phase 4 | United States |
| 11 | NCT00515437 (ClinicalTrials.gov) | July 2007 | 10/8/2007 | A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients | A Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients | Drooling | Biological: Botulinum Toxin Type B (Myobloc);Biological: Matched placebo to Myobloc | Solstice Neurosciences | NULL | Completed | 18 Years | 85 Years | All | 54 | Phase 2 | United States |
| 12 | NCT00477802 (ClinicalTrials.gov) | May 2007 | 22/5/2007 | Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease | Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease: A Double-Blind, Randomized, Placebo Controlled, Cross-Over Design Study | Parkinson Disease | Biological: Botulinum Toxin Type A;Biological: Placebo | University of Cincinnati | Allergan | Terminated | 35 Years | 75 Years | Both | 8 | Phase 4 | United States |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04819360 (ClinicalTrials.gov) | June 1, 2021 | 13/12/2020 | Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With Multiple Sclerosis | Injections of Botulinum Toxin A or Anticholinergic Treatment as First Line Therapy to Treat Neurogenic Overactive Bladder in Patients With Multiple Sclerosis | Urinary Bladder, Neurogenic;Multiple Sclerosis | Drug: VESIcare 10Mg Tablet;Drug: Botox 100 UNT Injection | Brigitte Schürch | Centre Hospitalier Universitaire Vaudois | Recruiting | 18 Years | 75 Years | All | 46 | Phase 4 | Switzerland |
| 2 | EUCTR2018-003231-30-ES (EUCTR) | 19/10/2018 | 17/09/2018 | EFFECTIVENESS OF REPEATED INJECTIONS OF BOTULINUM TOXIN IN THE GAIT AND QUALITY OF LIFE OF ADULT PATIENTS WITH WEAKNESS AND MUSCLE RIGIDITY DUE TO MULTIPLE ESCLEROSIS | EFFECTIVENESS OF THE REPEATED INFILTRATIONS OF BOTULINUM TOXIN A IN THE GAIT AND QUALITY OF LIFE IN ADULTS WITH SPASTIC PARAPARESIA SECONDARY TO MULTIPLE SCLEROSIS - BOTULINUM TOXIN IN PATIENTS WITH SPASTIC PARAPARESIA ASSOCIATED WITH ESCLEROSIS MULTIPLE | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport INN or Proposed INN: BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Aránzazu Vázquez Doce | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | Spain | ||
| 3 | EUCTR2015-003471-30-NL (EUCTR) | 02/11/2016 | 26/04/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Czech Republic;Taiwan;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of | ||
| 4 | EUCTR2015-003471-30-RO (EUCTR) | 26/09/2016 | 23/02/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | United States;Portugal;Czechia;Taiwan;Turkey;Italy;Czech Republic;Canada;Malaysia;Poland;Romania;Netherlands;Korea, Republic of | ||
| 5 | EUCTR2015-003471-30-PL (EUCTR) | 23/09/2016 | 15/07/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Czech Republic;Taiwan;Canada;Malaysia;Poland;Romania;Turkey;Netherlands;Italy;Korea, Republic of | ||
| 6 | EUCTR2015-000507-44-LT (EUCTR) | 11/07/2016 | 16/05/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 7 | NCT02660359 (ClinicalTrials.gov) | July 8, 2016 | 14/1/2016 | Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2 | 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® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis | Urinary Incontinence;Overactive Bladder | Biological: Botulinum toxin type A;Drug: Placebo | Ipsen | NULL | Terminated | 18 Years | 80 Years | All | 258 | Phase 3 | Argentina;Australia;Belgium;Brazil;Chile;Colombia;France;Germany;Israel;Lithuania;Mexico;Peru;Russian Federation;Spain;Ukraine;United Kingdom;New Zealand |
| 8 | EUCTR2015-000507-44-DE (EUCTR) | 29/06/2016 | 23/02/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Spain;Ukraine;Lithuania;Chile;Israel;Russian Federation;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 9 | EUCTR2015-003471-30-IT (EUCTR) | 30/05/2016 | 07/04/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | United States;Portugal;Taiwan;Czech Republic;Canada;Poland;Malaysia;Turkey;Romania;Netherlands;Italy;Korea, Republic of | ||
| 10 | EUCTR2015-003471-30-CZ (EUCTR) | 27/05/2016 | 16/03/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Czech Republic;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of | ||
| 11 | EUCTR2015-003471-30-PT (EUCTR) | 09/05/2016 | 08/03/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Portugal;Taiwan;Czech Republic;Canada;Poland;Malaysia;Turkey;Romania;Netherlands;Italy;Korea, Republic of | ||
| 12 | EUCTR2015-000507-44-ES (EUCTR) | 04/05/2016 | 18/03/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 13 | EUCTR2015-000507-44-FR (EUCTR) | 29/04/2016 | 21/03/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | Spain;Ukraine;Lithuania;Chile;Israel;Russian Federation;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 14 | EUCTR2015-000507-44-BE (EUCTR) | 31/03/2016 | 08/03/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | 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® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 15 | NCT02660138 (ClinicalTrials.gov) | March 2016 | 14/1/2016 | Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1 | 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® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis | Urinary Incontinence;Overactive Bladder | Biological: Botulinum toxin type A;Drug: Placebo | Ipsen | NULL | Terminated | 18 Years | 80 Years | All | 227 | Phase 3 | United States;Canada;Czechia;Italy;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Turkey;Czech Republic;Malaysia |
| 16 | NCT03033355 (ClinicalTrials.gov) | February 2014 | 15/7/2016 | Central Nervous System Changes Following BotulinumtoxinA Injection in the Bladder | A Prospective Study of Higher Neural Control Changes Following Intradetrusor Injection of BotulinumtoxinA in Patients With Multiple Sclerosis and Lower Urinary Tract Symptoms. | Multiple Sclerosis;Lower Urinary Tract Symptoms;Neurogenic Bladder;Detrusor, Overactive;Urge Incontinence | Drug: Intradetrusor injection of Botulinum Toxin-A | Rose Khavari, M.D. | The Methodist Hospital System | Completed | 18 Years | N/A | Female | 28 | United States | |
| 17 | NCT01911377 (ClinicalTrials.gov) | October 2013 | 25/7/2013 | Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS | The Efficacy of Botulinum Toxin Type A in the Treatment of Allodynic-Type Neuropathic Pain in People With Spinal Cord Injury or Multiple Sclerosis | Neuropathic Pain;Allodynia | Drug: Botulinum Toxin Type A;Drug: Normal Saline for Injection | University of Manitoba | Allergan | Terminated | 18 Years | 70 Years | Both | 12 | Phase 2 | Canada |
| 18 | EUCTR2012-000957-30-GB (EUCTR) | 05/03/2013 | 12/12/2012 | BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis | BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis | Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum Toxin Type A | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 184 | France;United States;Portugal;Czech Republic;Canada;Belgium;Poland;Russian Federation;United Kingdom | |||
| 19 | EUCTR2012-000957-30-PT (EUCTR) | 29/01/2013 | 12/11/2012 | BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis | BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis | Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum Toxin Type A | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 184 | France;United States;Portugal;Czech Republic;Canada;Belgium;Poland;Russian Federation;United Kingdom | |||
| 20 | EUCTR2010-023210-31-LT (EUCTR) | 12/09/2012 | 29/05/2012 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 21 | EUCTR2012-000957-30-CZ (EUCTR) | 11/09/2012 | 18/06/2012 | BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis | BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis | Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS) MedDRA version: 17.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum Toxin Type A | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 184 | Portugal;France;United States;Czech Republic;Canada;Poland;Belgium;Russian Federation;United Kingdom | |||
| 22 | EUCTR2010-023210-31-CZ (EUCTR) | 06/09/2012 | 13/06/2012 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 23 | EUCTR2012-000957-30-BE (EUCTR) | 28/08/2012 | 01/06/2012 | BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis | BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis | Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum Toxin Type A | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 184 | France;United States;Portugal;Czech Republic;Canada;Poland;Belgium;Russian Federation;United Kingdom | |||
| 24 | EUCTR2010-023210-31-IT (EUCTR) | 27/04/2012 | 12/03/2012 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: DYSPORT*SC IM 2FL 500U INN or Proposed INN: BOTULINUM TOXIN TYPE A | IPSEN INNOVATION | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 25 | EUCTR2010-023210-31-DE (EUCTR) | 24/02/2012 | 09/11/2011 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 15.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 26 | EUCTR2010-023210-31-AT (EUCTR) | 23/02/2012 | 18/01/2012 | The aim of the study is to assess the efficacy and safety of intra -detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 15.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 27 | NCT01357980 (ClinicalTrials.gov) | May 2011 | 17/5/2011 | Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis | A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis. | Detrusor Muscle Hyperactivity | Biological: Botulinum toxin type A;Drug: Placebo | Ipsen | NULL | Completed | 18 Years | 70 Years | All | 47 | Phase 2 | Czechia;France;Germany;Italy;Poland;Austria;Czech Republic |
| 28 | EUCTR2009-012431-15-CZ (EUCTR) | 21/01/2010 | 02/12/2009 | Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®. | Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®. | Studie se zabývá lécbou hyperaktivního neurogeního detruzoru u pacientu, kterí trpí príznaky hyperaktivního mocového mechýre jako dusledek spinálního poranení nebo roztroušené sklerózy. K lécbe se pužívá botulinumotoxin. Ve studii se porovnávaní dve ruzné formy aplikace studjiního léku. | Trade Name: Botox Other descriptive name: BOTULINUM TOXIN TYPE A | Krajská nemocnice Liberec, a.s. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Czech Republic | |||
| 29 | NCT00876447 (ClinicalTrials.gov) | January 1, 2009 | 1/4/2009 | A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis | Overactive Bladder | Biological: Botulinum Toxin Type A 300U;Biological: Botulinum Toxin Type A 200U | Allergan | NULL | Completed | 18 Years | N/A | All | 397 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Italy;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Singapore;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Czech Republic | |
| 30 | NCT01018485 (ClinicalTrials.gov) | October 2008 | 19/11/2009 | The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor | Double-Blind, Randomized, Controlled, Cross-over Comparison of Efficacy and Safety of Botulinum Toxin Type A in the Targeted Treatment of Disabling Tremor in Multiple Sclerosis | Multiple Sclerosis;Tremor | Drug: Botulinum Toxin Type A | Melbourne Health | Eastern Health | Completed | 18 Years | 80 Years | Both | 30 | Phase 3 | Australia |
| 31 | EUCTR2006-006299-39-FR (EUCTR) | 24/09/2008 | 06/08/2007 | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | Patients with urinary incontinence due to neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment. MedDRA version: 8.1;Level: LLT;Classification code 10046543;Term: Urinary incontinence | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum toxin type A Other descriptive name: Botulinum toxin type A | Allergan | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 3 | France;Netherlands | ||
| 32 | EUCTR2006-006299-39-NL (EUCTR) | 23/04/2008 | 13/06/2007 | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | Patients with urinary incontinence due to neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment. MedDRA version: 8.1;Level: LLT;Classification code 10046543;Term: Urinary incontinence | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum toxin type A Other descriptive name: Botulinum toxin type A | Allergan | NULL | Not Recruiting | Female: yes Male: yes | 135 | Netherlands;France | |||
| 33 | EUCTR2007-000192-42-IT (EUCTR) | 10/03/2008 | 31/07/2007 | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND | urinary incontinence caused by neurogenic detrusor overactivity (spinal lesion or multiple sclerosis) MedDRA version: 9.1;Level: LLT;Classification code 10029279;Term: Neurogenic bladder | Trade Name: BOTOX INN or Proposed INN: Botulinum toxin | ALLERGAN | NULL | Not Recruiting | Female: yes Male: yes | 260 | Portugal;United Kingdom;Germany;Netherlands;France;Spain;Italy | |||
| 34 | EUCTR2007-006268-32-IT (EUCTR) | 23/01/2008 | 23/11/2007 | EFFICACY AND SAFETYOF BOTULINUM TOXIN THERAPY ON UPPER LIMB SPASTICITY IN INFLAMMATORY AND DEMIELINIZZATING DISEASE OF CENTRAL NERVOUS SYSTEM. - ND | EFFICACY AND SAFETYOF BOTULINUM TOXIN THERAPY ON UPPER LIMB SPASTICITY IN INFLAMMATORY AND DEMIELINIZZATING DISEASE OF CENTRAL NERVOUS SYSTEM. - ND | multiple sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive | Trade Name: xeomin INN or Proposed INN: xeomin | OSPEDALE S. RAFFAELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 35 | NCT01091727 (ClinicalTrials.gov) | October 2006 | 22/3/2010 | Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity | Prospective Randomized Double-blind Trial of Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity and Urinary Incontinence Related to Spinal Cord Injury or Multiple Sclerosis | Neurogenic Detrusor Overactivity | Drug: Botulinum toxin A | Sunnybrook Health Sciences Centre | ethica Clinical Research Inc. | Completed | 18 Years | 75 Years | Both | 57 | Phase 3 | Canada |
149. 片側痙攣・片麻痺・てんかん症候群
臨床試験数 : 25 / 薬物数 : 35 - (DrugBank : 13) / 標的遺伝子数 : 16 - 標的パスウェイ数 : 22
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05615987 (ClinicalTrials.gov) | December 1, 2022 | 2/11/2022 | Comparison of Botulinum Toxin Injection Techniques in Spasticity | Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-blind Controlled Study. | Spastic Hemiplegia | Drug: Onabotulinumtoxina for Injection | Konya Beyhekim Training and Research Hospital | NULL | Not yet recruiting | 18 Years | 90 Years | All | 60 | Phase 4 | Turkey |
| 2 | NCT04630873 (ClinicalTrials.gov) | November 20, 2020 | 31/10/2020 | Low or High Botox Dilution for the Hemiplegic Gait? | Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait | Post Stroke Spastic Hemiplegia | Drug: Botulinum toxin;Diagnostic Test: gait analysis | University of Ioannina | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 1 | Greece |
| 3 | NCT03860662 (ClinicalTrials.gov) | May 26, 2018 | 8/2/2019 | The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex | Doctor, Physical Medicine and Rehabilitation | Stroke Sequelae;Spastic Hemiplegia | Diagnostic Test: Nociceptor flexor reflex;Drug: Botox;Drug: Baclofen | Mustafa Kemal University | NULL | Completed | 18 Years | 60 Years | All | 29 | Phase 4 | Turkey |
| 4 | ChiCTR-ICR-15007022 | 2014-05-01 | 2015-09-06 | A research of biomechanic stimulation and healing of hemiplegia gait | A research of biomechanic stimulation and healing of hemiplegia gait | stroke | botulinum toxin A type group:inject botulinum toxin A type;conventional treatment A group :conventional treatment;Dynamic electrical stimulation treatment group:Dynamic electrical stimulation;conventional treatment B group :conventional treatment;blank control group:null;validation group :botulinum toxin A type ; | Nanjing Sports Institude | NULL | Recruiting | 40 | 70 | Both | botulinum toxin A type group:30;conventional treatment A group :30;Dynamic electrical stimulation treatment group:30;conventional treatment B group :30;blank control group:30;validation group :30; | China | |
| 5 | EUCTR2009-015620-29-BE (EUCTR) | 08/03/2010 | 09/02/2010 | The efficacy of the Botulinum toxin-A on the manual abilities in children with congenital spastic hemiplegia. Interest of the measure of the bimanual task performance. | The efficacy of the Botulinum toxin-A on the manual abilities in children with congenital spastic hemiplegia. Interest of the measure of the bimanual task performance. | The main objective of this study is to investigate the effect of Botulinum toxin A to improve the Upper Limb dysfunction in Hemiplegic Cerebral Palsy Children and in particular, its impact on Upper limb activity performance and how this might be translate in bimanual activities. MedDRA version: 12.0;Level: LLT;Classification code 10019475;Term: Hemiplegic infantile cerebral palsy | Trade Name: BOTOX Product Name: BOTOX Product Code: 9060X Other descriptive name: BOTULINUM TOXIN TYPE A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Belgium | ||||
| 6 | NCT00276185 (ClinicalTrials.gov) | December 2005 | 12/1/2006 | HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke | Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke | Hemiplegia | Drug: Time delay treatment of botulinum toxin | University Hospital, Clermont-Ferrand | J. Rebeyrol Hospital in Limoges;Rennes University Hospital;Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes);Saint Jacques Hospital in Nantes;Centre Hospitalier Universitaire de Saint Etienne;Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers;Centre Hospitalier Universitaire de Besancon | Recruiting | 18 Years | N/A | Both | 180 | Phase 3 | France |