Xeomin ( DrugBank: - )


7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
5進行性核上性麻痺1
6パーキンソン病5
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2
15封入体筋炎1
17多系統萎縮症1
113筋ジストロフィー1

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
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
2NCT02419313
(ClinicalTrials.gov)
August 201227/1/2014Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized ApproachInvestigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized ApproachParkinson;TremorDrug: incobotulinumtoxinA;Drug: SalineYale UniversityNULLCompleted18 YearsN/AAll33Phase 2United States
3NCT01565395
(ClinicalTrials.gov)
March 201226/3/2012Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)Parkinson Disease;Amyotrophic Lateral SclerosisDrug: Incobotulinum Toxin A;Drug: placeboBeth Israel Deaconess Medical CenterMerz PharmaceuticalsWithdrawn20 Years80 YearsAll0Phase 2United States
4NCT01653132
(ClinicalTrials.gov)
March 201225/7/2012Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/ParkinsonismRandomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/ParkinsonismSialorrheaDrug: Incobotulinum Toxin A;Drug: PlaceboBeth Israel Deaconess Medical CenterNULLCompleted18 Years90 YearsAll10Phase 2United States
5NCT00909883
(ClinicalTrials.gov)
September 200919/5/2009Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles)Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles)Parkinson's Disease;Foot DystoniaDrug: Botulinum Toxin: Xeomin;Drug: PlaceboUniversity Hospital, Clermont-FerrandMerz Pharma FranceRecruiting30 Years75 YearsBoth45Phase 3France

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
1NCT01968902
(ClinicalTrials.gov)
November 201321/10/2013Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis PatientsA Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Incobotulinumtoxin Type A for the Functional Improvement of Lower Extremity Spasticity in Patients With Multiple SclerosisMuscle Spasticity;Multiple SclerosisBiological: incabotulinumtoxinA;Biological: PlaceboMultiple Sclerosis Center of Northeastern New YorkMerz North America, Inc.Completed18 Years65 YearsAll27Phase 4United States
2EUCTR2007-006268-32-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

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

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