EUCTR2007-000735-26-SE进行中（未招募）不适用
A Multicentre, Double-Blind, Prospective, Randomised, European and Canadian Study to Evaluate Patient Outcomes and Costs of Managing Adults with Spasticity and Associated Focal Spasticity. - BOTOX® Economic Spasticity Trial (BEST)
Allergan Ltd.0 个研究点目标入组 300 人开始时间: 2007年5月15日最近更新:
适应症
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
- 300
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 between 18 and 85 years of age
- •2.Patients with stroke due to a primary cerebral haemorrhage/ infarction, subarachnoid haemorrhage producing an upper motor syndrome affecting one body side which results in a hemi-paralysis/plegia
- •3.Patients suitable for botulinum toxin type A (BOTOX®)
- •4.Patients with documented focal/multifocal problems of spasticity in the upper and/or lower limbs and for who functional gains are anticipated after treatment with BOTOX® + SC
- •Patients treated for upper limb spasticity: evidence of preserved antagonist function and at least one item of the REsistance to PAssive movement Scale (REPAS) with a score of at least 1 at the relevant joint(s) for the primary endpoint
- •Patients treated for lower limb spasticity: evidence of preserved standing/ambulation function and at least one item of the REPAS with a score of at least 1 at the relevant joint(s) for the primary endpoint
- •5.Patients with spasticity, as defined in criterion #4 above, caused by a stroke that happened 3 months or more before the Screening visit
- •6.Female patients either surgically sterile (has had a tubal ligation, documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a urine pregnancy test is negative and agree to use birth control (e.g. hormonal contraception [estrogen or progesterone agents], intrauterine contraceptive device, double barrier methods [condom with spermicide, diaphragm with spermicide, or male condom and diaphragm], or total sexual abstinence) during the study
- •7.Patients able to communicate effectively, with the help of a third person completing answers on their behalf (when required)
- •8.Patients willing and able to come to each study protocol visit and answer questions by phone on a monthly basis, possibly with the assistance of a caregiver
- •9.Patients willing and able to provide a signed and dated written informed consent
- •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.Patients with fixed contracture as a result of spasticity in the upper or lower limb planned to be treated
- •2.Patients with other causes of spasticity (e.g. multiple sclerosis, spinal cord injury, etc.)
- •3.Patients who have been previously treated with botulinum toxin or phenol nerve block in the limbs to be injected during this trial
- •4.Patients requiring concomitant use of intrathecal baclofen or phenol nerve block at any point during the study; patients requiring systemic aminoglycoside antibiotics or spectinomycin during the period from at least 3 days before until 6 weeks after injection of study medication.
- •5.Patients who are currently taking part in any other clinical trial or have taken part in a clinical trial of a new chemical entity within 6 months prior to Screening
- •6.Patients with a Mini-Mental State Examination (MMSE) < 20
- •7.Patients not sufficiently motivated to participate in the study as determined by an Apathy Evaluation Scale score > 40
- •8.Patients with known medical conditions (e.g. cardiac condition, cancer, etc.) that would affect their ability to benefit from treatment or to complete the study
- •9.Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin)
- •10.Patients with myasthenia gravis or Eaton Lambert Syndrome
- •11.Patients with infection at the proposed injection site(s)
研究者
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A Multicentre, Double-Blind, Prospective, Randomised, European and Canadian Study to Evaluate Patient Outcomes and Costs of Managing Adults with Spasticity and Associated Focal Spasticity. - BOTOX® Economic Spasticity Trial (BEST)EUCTR2007-000735-26-DEAllergan Ltd.300
进行中（未招募）
1 期
A Multicentre, Double-Blind, Prospective, Randomised, European and Canadian Study to Evaluate Patient Outcomes and Costs of Managing Adults with Spasticity and Associated Focal Spasticity. - BOTOX® Economic Spasticity Trial (BEST)Spasticity and Associated Focal SpasticityMedDRA version: 9.1 Level: LLT Classification code 10041416 Term: SpasticityEUCTR2007-000735-26-GBAllergan Ltd.300
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