13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
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 | 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 |
| 17 | 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 | |||
| 18 | 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 | |||
| 19 | 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 | ||
| 20 | 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 | |||
| 21 | 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 | ||
| 22 | 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 | |||
| 23 | NCT01600716 (ClinicalTrials.gov) | June 13, 2012 | 15/5/2012 | Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS) | Urinary Incontinence;Multiple Sclerosis;Neurogenic Bladder | Biological: OnabotulinumtoxinA;Drug: Placebo (Normal Saline) | Allergan | NULL | Completed | 18 Years | N/A | All | 144 | Phase 3 | United States;Belgium;Canada;Czechia;France;Poland;Portugal;Russian Federation;Czech Republic | |
| 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 | 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 |