BOTULINUM TOXIN TYPE A ( DrugBank: Botulinum toxin type A )


10 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症2
5進行性核上性麻痺1
6パーキンソン病8
7大脳皮質基底核変性症1
13多発性硬化症/視神経脊髄炎31
15封入体筋炎1
17多系統萎縮症1
70広範脊柱管狭窄症1
113筋ジストロフィー1
149片側痙攣・片麻痺・てんかん症候群1

2. 筋萎縮性側索硬化症


臨床試験数 : 624 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01551940
(ClinicalTrials.gov)
February 20129/3/2012Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related SialorrheaEvaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS)Sialorrhea;Amyotrophic Lateral SclerosisDrug: Botox injection;Drug: Placebo injectionHospices Civils de LyonNULLCompleted18 YearsN/ABoth18Phase 2France
2EUCTR2010-023161-21-FR
(EUCTR)
23/11/201106/09/2011Sclérose Latérale Amyotrophique (SLA) – toxine botulinique A (Botox®)Evaluation de la toxine botulinique dans le traitement du trouble salivaire chez le patient atteint de sclérose latérale amyotrophique - SLA-TOX Sclérose Latérale Amyotrophique (SLA)
MedDRA version: 14.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BOTOX 100 UNITES ALLERGAN (PR1)
Other descriptive name: BOTULINUM TOXIN TYPE A
Hospices Civils de LyonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2France

5. 進行性核上性麻痺


臨床試験数 : 95 薬物数 : 119 - (DrugBank : 40) / 標的遺伝子数 : 65 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-005539-10-DE
(EUCTR)
29/04/201418/12/2013Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Poland;Germany

6. パーキンソン病


臨床試験数 : 2,298 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04277247
(ClinicalTrials.gov)
November 2, 202010/2/2020Botulinum Toxin Type A for Foot Dystonia-associated Pain in Parkinson's DiseaseBotulinum Toxin A (Onabotulinumtoxin A) for Foot Dystonia-associated Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Control StudyDystonia Disorder;Parkinson DiseaseDrug: Botulinum toxin type A;Drug: PlaceboUniversity of CalgaryAllerganRecruiting30 Years100 YearsAll40Phase 2/Phase 3Canada
2ChiCTR-INR-17012013
2017-09-012017-07-17Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's diseaseClinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease Parkinson‘s disease, DepressionBTX-A:BOTOX Allergan;Placebo:0.9% Sodium Chloride Injection;Shanghai Tongji Hospital, Tongji UniversityNULLPending1880BothBTX-A:40;Placebo:40;China
3NCT02668497
(ClinicalTrials.gov)
March 201626/1/2016Kinematic-based BoNT-A Bilateral Upper Limb PD TherapyKinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A TherapyParkinson's DiseaseDrug: Botulinum Toxin Type AWestern University, CanadaNULLActive, not recruiting18 Years80 YearsAll50Phase 2Canada
4NCT02472210
(ClinicalTrials.gov)
July 201411/6/2015The Use of Botox in Advanced Parkinson's Patients Experiencing PainA Study of the Utility of Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease Double Blind Placebo Control Crossover Pilot StudyParkinson's DiseaseDrug: Botulinum ToxinUniversity Health Network, TorontoNULLActive, not recruiting18 YearsN/ABoth14Phase 4NULL
5EUCTR2012-005539-10-DE
(EUCTR)
29/04/201418/12/2013Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Poland;Germany
6EUCTR2009-017412-32-IT
(EUCTR)
13/12/201127/04/2010RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - NDRANDOMISED 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.SALESINULLNot RecruitingFemale: yes
Male: yes
Italy
7NCT02427646
(ClinicalTrials.gov)
October 201122/4/2015Kinematic-guided BoNT-A Treatment for ET and PD TremorUse of Kinematic Assessment of Hand Tremor Pre- and Post- Treatment With Botulinum Toxin Type A in Essential Tremor and Parkinson DiseaseTremorDrug: BoNT-AWestern University, CanadaNULLActive, not recruiting18 Years80 YearsAll54Phase 2NULL
8NCT00477802
(ClinicalTrials.gov)
May 200722/5/2007Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's DiseaseBotulinum 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 StudyParkinson DiseaseBiological: Botulinum Toxin Type A;Biological: PlaceboUniversity of CincinnatiAllerganTerminated35 Years75 YearsBoth8Phase 4United States

7. 大脳皮質基底核変性症


臨床試験数 : 18 薬物数 : 35 - (DrugBank : 13) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 38
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-005539-10-DE
(EUCTR)
29/04/201418/12/2013Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Poland;Germany

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04595045
(ClinicalTrials.gov)
January 24, 20199/9/2020Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated With Multiple SclerosisEffectiveness of Botulinum Toxin Type A Infiltrations in the Gait and Quality of Life in Adults With Spastic Lower Limb Paresis Secondary to Multiple SclerosisMultiple SclerosisDrug: Botulinum toxin type A infiltrationsAránzazu Vázquez DoceNULLActive, not recruiting18 Years80 YearsAll84Phase 3Spain
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-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
5EUCTR2015-000507-44-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
6NCT02660359
(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
7EUCTR2015-000507-44-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
8EUCTR2015-003471-30-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 InnovationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
408Phase 3Portugal;United States;Czech Republic;Taiwan;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of
9EUCTR2015-003471-30-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
10EUCTR2015-003471-30-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
11EUCTR2015-000507-44-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
12EUCTR2015-000507-44-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
13EUCTR2015-000507-44-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
14NCT02660138
(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
15NCT01911377
(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
16EUCTR2012-000957-30-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
17EUCTR2012-000957-30-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
18EUCTR2010-023210-31-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
19EUCTR2012-000957-30-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
20EUCTR2010-023210-31-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
21EUCTR2012-000957-30-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
22EUCTR2010-023210-31-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
23EUCTR2010-023210-31-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
24EUCTR2010-023210-31-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
25NCT01357980
(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
26EUCTR2009-012431-15-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
27NCT00876447
(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
28NCT01018485
(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
29EUCTR2006-006299-39-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
AllerganNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Netherlands;France
30EUCTR2006-006299-39-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
31EUCTR2007-000192-42-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

15. 封入体筋炎


臨床試験数 : 42 薬物数 : 60 - (DrugBank : 16) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 123
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-002210-23-DK
(EUCTR)
14/10/201402/06/2014Can local botulinum toxin improve swallowing difficulties in persons with msucle disease?Can local intramuscular botulinum toxin improve dysphagia in patients with myopathic dysphagia and constriction of the cricoid muscle? Oculopharyngesl muscle dystrophy, inclusion body myositis
MedDRA version: 18.1;Level: LLT;Classification code 10019897;Term: Hereditary progressive muscular dystrophy;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Xeomin
Product Name: Xeomin
Other descriptive name: BOTULINUM TOXIN TYPE A
RigshospitaletNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noDenmark

17. 多系統萎縮症


臨床試験数 : 118 薬物数 : 163 - (DrugBank : 49) / 標的遺伝子数 : 61 - 標的パスウェイ数 : 112
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-005539-10-DE
(EUCTR)
29/04/201418/12/2013Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Poland;Germany

70. 広範脊柱管狭窄症


臨床試験数 : 96 薬物数 : 203 - (DrugBank : 60) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 89
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02444351
(ClinicalTrials.gov)
June 26, 201528/4/2015Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal StenosisSpinal Stenosis With Nocturnal Calf CrampsDrug: botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle;Other: no interventionYonsei UniversityNULLCompleted20 Years80 YearsAll50N/AKorea, Republic of

113. 筋ジストロフィー


臨床試験数 : 622 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-002210-23-DK
(EUCTR)
14/10/201402/06/2014Can local botulinum toxin improve swallowing difficulties in persons with msucle disease?Can local intramuscular botulinum toxin improve dysphagia in patients with myopathic dysphagia and constriction of the cricoid muscle? Oculopharyngesl muscle dystrophy, inclusion body myositis
MedDRA version: 18.1;Level: LLT;Classification code 10019897;Term: Hereditary progressive muscular dystrophy;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Xeomin
Product Name: Xeomin
Other descriptive name: BOTULINUM TOXIN TYPE A
RigshospitaletNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noDenmark

149. 片側痙攣・片麻痺・てんかん症候群


臨床試験数 : 25 薬物数 : 40 - (DrugBank : 14) / 標的遺伝子数 : 17 - 標的パスウェイ数 : 20
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-015620-29-BE
(EUCTR)
08/03/201009/02/2010The 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
NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Belgium