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

  
35 trials found
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PhaseCountries
1NCT04819360
(ClinicalTrials.gov)
June 1, 202113/12/2020Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With Multiple SclerosisInjections of Botulinum Toxin A or Anticholinergic Treatment as First Line Therapy to Treat Neurogenic Overactive Bladder in Patients With Multiple SclerosisUrinary Bladder, Neurogenic;Multiple SclerosisDrug: VESIcare 10Mg Tablet;Drug: Botox 100 UNT InjectionBrigitte SchürchCentre Hospitalier Universitaire VaudoisRecruiting18 Years75 YearsAll46Phase 4Switzerland
2EUCTR2018-003231-30-ES
(EUCTR)
19/10/201817/09/2018EFFECTIVENESS OF REPEATED INJECTIONS OF BOTULINUM TOXIN IN THE GAIT AND QUALITY OF LIFE OF ADULT PATIENTS WITH WEAKNESS AND MUSCLE RIGIDITY DUE TO MULTIPLE ESCLEROSISEFFECTIVENESS 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 DoceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3Spain
3EUCTR2015-003471-30-NL
(EUCTR)
02/11/201626/04/2016A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosisA 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 InnovationNULLNot 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): noPortugal;United States;Czech Republic;Taiwan;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of
4EUCTR2015-003471-30-RO
(EUCTR)
26/09/201623/02/2016A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosisA 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 InnovationNULLNot RecruitingFemale: yes
Male: yes
408Phase 3United States;Portugal;Czechia;Taiwan;Turkey;Italy;Czech Republic;Canada;Malaysia;Poland;Romania;Netherlands;Korea, Republic of
5EUCTR2015-003471-30-PL
(EUCTR)
23/09/201615/07/2016A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosisA 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 InnovationNULLNot 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): noPortugal;United States;Czech Republic;Taiwan;Canada;Malaysia;Poland;Romania;Turkey;Netherlands;Italy;Korea, Republic of
6EUCTR2015-000507-44-LT
(EUCTR)
11/07/201616/05/2016A 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 sclerosisA 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 InnovationNULLNot 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): noSpain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand
7NCT02660359
(ClinicalTrials.gov)
July 8, 201614/1/2016Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2A 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 SclerosisUrinary Incontinence;Overactive BladderBiological: Botulinum toxin type A;Drug: PlaceboIpsenNULLTerminated18 Years80 YearsAll258Phase 3Argentina;Australia;Belgium;Brazil;Chile;Colombia;France;Germany;Israel;Lithuania;Mexico;Peru;Russian Federation;Spain;Ukraine;United Kingdom;New Zealand
8EUCTR2015-000507-44-DE
(EUCTR)
29/06/201623/02/2016A 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 sclerosisA 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 InnovationNULLNot RecruitingFemale: yes
Male: yes
330Phase 3Spain;Ukraine;Lithuania;Chile;Israel;Russian Federation;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand
9EUCTR2015-003471-30-IT
(EUCTR)
30/05/201607/04/2016A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosisA 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 InnovationNULLNot RecruitingFemale: yes
Male: yes
408Phase 3United States;Portugal;Taiwan;Czech Republic;Canada;Poland;Malaysia;Turkey;Romania;Netherlands;Italy;Korea, Republic of
10EUCTR2015-003471-30-CZ
(EUCTR)
27/05/201616/03/2016A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosisA 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 InnovationNULLNot 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): noPortugal;United States;Taiwan;Czech Republic;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of
11EUCTR2015-003471-30-PT
(EUCTR)
09/05/201608/03/2016A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosisA 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 InnovationNULLNot RecruitingFemale: yes
Male: yes
330Phase 3United States;Portugal;Taiwan;Czech Republic;Canada;Poland;Malaysia;Turkey;Romania;Netherlands;Italy;Korea, Republic of
12EUCTR2015-000507-44-ES
(EUCTR)
04/05/201618/03/2016A 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 sclerosisA 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 InnovationNULLNot RecruitingFemale: yes
Male: yes
408Phase 3Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand
13EUCTR2015-000507-44-FR
(EUCTR)
29/04/201621/03/2016A 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 sclerosisA 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 InnovationNULLNot RecruitingFemale: yes
Male: yes
408Phase 3Spain;Ukraine;Lithuania;Chile;Israel;Russian Federation;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand
14EUCTR2015-000507-44-BE
(EUCTR)
31/03/201608/03/2016A 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 sclerosisA 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 InnovationNULLNot 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): noSpain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand
15NCT02660138
(ClinicalTrials.gov)
March 201614/1/2016Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1A 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 SclerosisUrinary Incontinence;Overactive BladderBiological: Botulinum toxin type A;Drug: PlaceboIpsenNULLTerminated18 Years80 YearsAll227Phase 3United States;Canada;Czechia;Italy;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Turkey;Czech Republic;Malaysia
16NCT03033355
(ClinicalTrials.gov)
February 201415/7/2016Central Nervous System Changes Following BotulinumtoxinA Injection in the BladderA 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 IncontinenceDrug: Intradetrusor injection of Botulinum Toxin-ARose Khavari, M.D.The Methodist Hospital SystemCompleted18 YearsN/AFemale28United States
17NCT01911377
(ClinicalTrials.gov)
October 201325/7/2013Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MSThe Efficacy of Botulinum Toxin Type A in the Treatment of Allodynic-Type Neuropathic Pain in People With Spinal Cord Injury or Multiple SclerosisNeuropathic Pain;AllodyniaDrug: Botulinum Toxin Type A;Drug: Normal Saline for InjectionUniversity of ManitobaAllerganTerminated18 Years70 YearsBoth12Phase 2Canada
18EUCTR2012-000957-30-GB
(EUCTR)
05/03/201312/12/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® 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.NULLNot RecruitingFemale: yes
Male: yes
184France;United States;Portugal;Czech Republic;Canada;Belgium;Poland;Russian Federation;United Kingdom
19EUCTR2012-000957-30-PT
(EUCTR)
29/01/201312/11/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® 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.NULLNot RecruitingFemale: yes
Male: yes
184France;United States;Portugal;Czech Republic;Canada;Belgium;Poland;Russian Federation;United Kingdom
20EUCTR2010-023210-31-LT
(EUCTR)
12/09/201229/05/2012The 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 InnovationNULLNot RecruitingFemale: yes
Male: yes
56Phase 2Czech Republic;Lithuania;Austria;Germany;Italy
21EUCTR2012-000957-30-CZ
(EUCTR)
11/09/201218/06/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® 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.NULLNot RecruitingFemale: yes
Male: yes
184Portugal;France;United States;Czech Republic;Canada;Poland;Belgium;Russian Federation;United Kingdom
22EUCTR2010-023210-31-CZ
(EUCTR)
06/09/201213/06/2012The 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 InnovationNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Czech Republic;Lithuania;Austria;Germany;Italy
23EUCTR2012-000957-30-BE
(EUCTR)
28/08/201201/06/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® 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.NULLNot RecruitingFemale: yes
Male: yes
184France;United States;Portugal;Czech Republic;Canada;Poland;Belgium;Russian Federation;United Kingdom
24EUCTR2010-023210-31-IT
(EUCTR)
27/04/201212/03/2012The 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 sclerosisA 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 INNOVATIONNULLNot RecruitingFemale: yes
Male: yes
56Phase 2Czech Republic;Lithuania;Austria;Germany;Italy
25EUCTR2010-023210-31-DE
(EUCTR)
24/02/201209/11/2011The 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 InnovationNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Czech Republic;Lithuania;Austria;Germany;Italy
26EUCTR2010-023210-31-AT
(EUCTR)
23/02/201218/01/2012The 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 InnovationNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Czech Republic;Lithuania;Austria;Germany;Italy
27NCT01357980
(ClinicalTrials.gov)
May 201117/5/2011Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple SclerosisA 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 HyperactivityBiological: Botulinum toxin type A;Drug: PlaceboIpsenNULLCompleted18 Years70 YearsAll47Phase 2Czechia;France;Germany;Italy;Poland;Austria;Czech Republic
28EUCTR2009-012431-15-CZ
(EUCTR)
21/01/201002/12/2009Možnosti 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Czech Republic
29NCT00876447
(ClinicalTrials.gov)
January 1, 20091/4/2009A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple SclerosisOveractive BladderBiological: Botulinum Toxin Type A 300U;Biological: Botulinum Toxin Type A 200UAllerganNULLCompleted18 YearsN/AAll397Phase 3United 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
30NCT01018485
(ClinicalTrials.gov)
October 200819/11/2009The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) TremorDouble-Blind, Randomized, Controlled, Cross-over Comparison of Efficacy and Safety of Botulinum Toxin Type A in the Targeted Treatment of Disabling Tremor in Multiple SclerosisMultiple Sclerosis;TremorDrug: Botulinum Toxin Type AMelbourne HealthEastern HealthCompleted18 Years80 YearsBoth30Phase 3Australia
31EUCTR2006-006299-39-FR
(EUCTR)
24/09/200806/08/2007A 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 ImpairmentA 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
AllerganNULLNot RecruitingFemale: yes
Male: yes
135Phase 3France;Netherlands
32EUCTR2006-006299-39-NL
(EUCTR)
23/04/200813/06/2007A 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 ImpairmentA 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
AllerganNULLNot RecruitingFemale: yes
Male: yes
135Netherlands;France
33EUCTR2007-000192-42-IT
(EUCTR)
10/03/200831/07/2007A 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 - NDA 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
ALLERGANNULLNot RecruitingFemale: yes
Male: yes
260Portugal;United Kingdom;Germany;Netherlands;France;Spain;Italy
34EUCTR2007-006268-32-IT
(EUCTR)
23/01/200823/11/2007EFFICACY AND SAFETYOF BOTULINUM TOXIN THERAPY ON UPPER LIMB SPASTICITY IN INFLAMMATORY AND DEMIELINIZZATING DISEASE OF CENTRAL NERVOUS SYSTEM. - NDEFFICACY 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. RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
35NCT01091727
(ClinicalTrials.gov)
October 200622/3/2010Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor OveractivityProspective 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 SclerosisNeurogenic Detrusor OveractivityDrug: Botulinum toxin ASunnybrook Health Sciences Centreethica Clinical Research Inc.Completed18 Years75 YearsBoth57Phase 3Canada