EUCTR2006-003410-18-DE进行中（未招募）不适用
Prospective, single-arm, multicenter trial to investigate the efficacy and safety of NT 201 (botulinum neurotoxin type A free of complexing proteins) and the duration of treatment effect after one injection session and in long-term treatment in patients with cervical dystonia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- Willingness of the patient to participate as documented by written informed consent
- •- Male or female patient aged = 18 and < 76 years
- •- A clinical diagnosis of cervical dystonia, i.e., spasmodic torticollis, of predominantly rotational form with a need for injection. Cervical dystonia is characterized by involuntary, inappropriate neuromuscular hyperactivity in neck and shoulder muscles leading to abnormal head movements and postures
- •- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS, see protocol) – total score at baseline = 25
- •- TWSTRS – severity score = 10
- •- TWSTRS – disability score = 3
- •- Patient must be on a stable dose of other medications (if any) used for focal dystonia treatment (e.g., anticholinergics and benzodiazepines) for = 3 months prior to and throughout the Main Period and if possible, throughout the Extension Period
- •- Negative pregnancy test at trial entry for female of childbearing potential (premenopausal female or postmenopausal female with last menses less than 12 months ago)
- •- Woman of childbearing potential using highly effective methods of birth control, defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as hormonal contraception or intrauterine contraceptive device or combination of two barrier methods (e.g., condom or diaphragm plus spermicidal cream)
- •- For pre-treated patients only: Source documentation of the last two consecutive injection sessions with botulinum neurotoxin type A and stable treatment response directly prior to trial entry.
- •- For pre-treated patients only: At least 10 weeks must have passed between the last injection session with botulinum neurotoxin type A for cervical dystonia and the time of the baseline visit.
- •- For pre-treated patients only: The most recent injection session with botulinum neurotoxin for cervical dystonia must have been at a dose of = 300 units of Botox® or Xeomin® or = 1,200 units Dysport®
- •For the longterm extension period:
- •- Negative pregnancy test for female of childbearing potential (premenopausal female or postmenopausal female with last menses less than 12 months ago)
- •- Woman of childbearing potential using highly effective methods of birth control, defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as hormonal contraception or intrauterine contraceptive device or combination of two barrier methods (e.g., condom or diaphragm plus spermicidal cream)
- •- At least 10 weeks must have been passed since the last injection session with botulinum neurotoxin type A for cervical dystonia
- •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
- •- Pre-treatment with botulinum neurotoxin type B (Neurobloc®) at any time prior to study entry
- •- Concomitant treatment with botulinum neurotoxin of any serotype for any other indication (including aesthetic indications) and for any body region during the trial
- •- Traumatic torticollis and tardive torticollis
- •- Previous or planned myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation and/or spinal cord stimulation)
- •- Hypersensitivity to human serum albumin, sucrose or botulinum neurotoxin type A
- •- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the trial
- •- Severe swallowing disorder of any origin (Dysphagia Scale score = 3 = severe, with swallowing difficulties and requiring a change in diet)
- •- Predominantly marked limitation on passive range of motion that clinically suggests fixed structures, e.g., cervical contractures or cervical spine syndrome
- •- Present or pre-existing blood coagulation disorders including therapeutic or prophylactic anticoagulation (e.g., heparin, phenprocoumon)
- •- Infection in the area of the planned injection sites or systemic infection presenting a hazard for local injections into the neck muscles
- •- Non-authorized concomitant treatment (see protocol section Prior and Concomitant Therapy)
- •- Current participation in another investigational clinical trial or participation in a clinical trial within the past 3 months
- •- Inability of patient to give informed consent
- •- Nursing mother
- •- Any severe or uncontrolled systemic disease (e.g., cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or known HIV infection in medical history
- •- Planned elective surgery under general anesthesia during the trial
- •- Known current alcoholism or other drug abuse/dependence
- •- Being an employee or direct relative of an employee of the involved CRO, the Study Center or Merz Pharmaceuticals
- •For the long-term extension period:
- •- Concomitant treatment with botulinum neurotoxin of any serotype for any other indication (including aesthetic reasons) and for any body region during the trial
- •- Planned myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation and/or spinal cord stimulation)
- •- Severe swallowing disorder of any origin (Dysphagia Scale score ³ 3 = severe, with swallowing difficulties and requiring a change in diet
- •- Predominantly marked limitation on passive range of motion that clinically suggests fixed structures, e.g., cervical contractures or cervical spine syndrome
- •- Present or pre-existing blood coagulation disorder including therapeutic or prophylactic anticoagulation (e.g., heparin, phenprocoumon)
- •- Infection in the area of the planned injection sites or systemic infection presenting a hazard for local injections into the neck muscles
- •- Non-authorized concomitant treatment (see protocol section Prior and Concomitant Therapy9.4.7)
- •- Nursing mother
- •- Any severe or uncontrolled systemic disease (e.g., cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of HIV infection
- •- Planned elective surgery under general anesthesia during the trial
- •- Known current alcoholism or other drug abuse/dependence
研究者
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