EUCTR2007-004530-16-GB进行中（未招募）不适用
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Single Treatment Cycle, Parallel Evaluation of the Safety, Efficacy and Immunogenicity of Two Formulations of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex (Formulation Nos. 9060X and 9525X) Followed by a Blinded Active Treatment Extension of Up to Two Additional Treatment Cycles in Patients with Cervical Dystonia
Allergan, Ltd.0 个研究点目标入组 200 人开始时间: 2007年11月26日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female patients, 18 - 75 years of age with clinically diagnosed idiopathic cervical dystonia or segmental or generalized dystonia in which cervical dystonia is the predominant feature
- •2.Knowledge and ability (were it not for the cervical dystonia) to participate in all activities except driving mentioned in the TWSTRS Disability subscale.
- •3.A total score of = 20 on the total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
- •4.A TWSTRS torticollis severity score of = 10
- •5.A TWSTRS pain subscale score of =1
- •6.One of the following:
- •(a) no treatment for cervical dystonia (CD) within 6 weeks prior to Day 1
- •(b) existing treatment for CD is stable (ie, no changes within 6 weeks) prior to Day 1 (randomization) and is anticipated to remain stable throughout the study. This includes any pharmacological or non-pharmacological treatment
- •7.Negative urine pregnancy test on Day 1 immediately prior to injection for female patients of child-bearing potential
- •8.Screening laboratory values (hematology and chemistry) either within the reference ranges as defined by the central laboratory or in the investigator’s opinion out–of range test results that are acceptable to the investigator with the agreement from the medical monitor
- •9.Written informed consent has been obtained
- •10.Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained
- •11.Written Data Protection Consent (European sites only) has been obtained
- •12.Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
- •13.Ability to be readily contactable by telephone for the duration of the study
- •14.Ability to follow study instructions and likely to complete all study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Uncontrolled medical condition other than the condition under evaluation
- •2.Concurrent or previous botulinum toxin treatment of any serotype for any condition, or immunization to any botulinum toxin serotype
- •3.Any medical condition that may place the patient at increased risk with exposure to BOTOX® or BOTOX® rHA-R including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other condition that might interfere with neuromuscular function
- •4.Known allergy or sensitivity to the study medication(s) or its components
- •5.Previous surgical procedure involving bone or muscle for the management of cervical dystonia
- •6.Previous injections of phenol or alcohol that, in the investigator’s opinion, have altered muscle anatomy
- •7.Profound atrophy of the muscles to be injected
- •8.Presence of pure latero and/or antero/retrocollis, or pure shift. Neck contracture producing decreased range of motion
- •9.Anticipated need during the study for any surgical procedure for the management of cervical dystonia that might result in a modification of the patient’s dose of study drug
- •10.Infection or skin problem at the anticipated injection sites
- •11.Patient is female and pregnant, nursing or planning a pregnancy during the study or is of child-bearing potential and unable or unwilling to use a reliable form of contraception during the study
- •12.Anticipated need for botulinum toxin treatment of any serotype for any indication (other than the study treatment for cervical dystonia) during the study
- •13.Recent history in the past two years of alcohol or drug abuse
- •14.Anticipated need for surgery or hospitalization during the study
- •15.Concurrent participation in another investigational drug or device study or participation in such a study within 30 days of entry into this study
- •16.Patient has a condition or is in a situation which in the investigator’s opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study
研究者
相似试验
进行中（未招募）
不适用
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - NDEUCTR2007-000192-42-ITALLERGA260
进行中（未招募）
不适用
Study of the Safety and Efficacy of BOTOX® in Patients with Idiopathic Overactive Bladder with Urinary Incontinence.EUCTR2009-013088-20-PLAllergan Ltd534
进行中（未招募）
1 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-ResponseStudy to Evaluate the Safety and Efficacy of a Single Treatment of BOTOX®(Botulinum Toxin Type A) Purified Neurotoxin Complex Injected into the Prostatefor the Treatment of Lower Urinary Tract Symptoms in Patients due to BenignProstatic HyperplasiaEUCTR2005-004281-17-FRAllergan Inc.300
进行中（未招募）
1 期
A clinical trial to investigate the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Gastroparesisdiabetic or idiopathic gastroparesis.MedDRA version: 19.0Level: LLTClassification code 10021227Term: Idiopathic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 19.0Level: PTClassification code 10051153Term: Diabetic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2014-003250-13-PLTheravance Biopharma R&D, Inc.200
进行中（未招募）
不适用
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX® in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivityrinary incontinence due to neurogenic detrusor overactivityMedDRA version: 9.1Level: LLTClassification code 10029279Term: Neurogenic bladderEUCTR2007-000192-42-NLAllergan Ltd260