EUCTR2014-001959-24-DE进行中（未招募）不适用
BoTN: Onabotulinumtoxin A for the treatment of trigeminal neuralgia: Efficacy, safety and neurophysiological alterations under therapy – a prospective, controlled trial
niversity Hospital Essen0 个研究点目标入组 20 人开始时间: 2014年6月27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
- 20
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
- •Male and female patients of 18 years of age,
- •Patients of legal competence,
- •Sufficient knowledge of written and spoken German,
- •Diagnosis of classical trigeminal neuralgia according to the International Classification of Headache Disorders, third edition
- •Min. three bouts per day between Screening and Baseline
- •Unmodified prophylactic medication for TN (anti-epileptic drugs / Baclofen) during the last four weeks before study participation
- •Unmodified dosing of medication which may have an influence on the frequence and intensity of bouts of TN (tricyclic antidepressants, opiods)
- •Min. one therapeutic attempt of TN with Carbamazepin and in appropriate dose (min. 600 mg / d) either inadequate efficacy or intolerance during therapy
- •Patient willing and capable of attending regular examination and follow-up visits and completing patient questionnaires accurately
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Intolerance or contraindications against Botox® according to SmPC:
- •o known intolerance/hypersensitivity against BoTN-A
- •o local inflammation / sign of infection at allocated injection site
- •Pre-existing diseases with special warning notices according to SmPC:
- •Known periphal motor neuropathic disease (e.g. amyotrophic lateral sclerosis)
- •Known dysphagia, history of aspiration
- •Known corneal ulceration
- •History of neuromuscular disease (e.g. myasthenia gravis, Duchenne muscular dystrophy, Lambert-Eaton-Syndrome)
- •Severe allergic diathesis
- •Symptomatic cause of trigeminal complaints in terms of trigeminal neuropathic pain (e.g. associated with Herpes zoster, MSPlaque, post-traumatic or caused by local spherical mass)
- •Trigeminal autonomic syndroms (SUNCT/SUNA, paroxysmal hemicrania, cluster headache)
- •Ongoing substance/alcohol/medication abuse/dependence
- •Known dysfunction of haemostasis (anamnesis, laboratory)
- •Medical history, which induces an effective anticoagulation (e.g. atrial fibrillation)
- •Severe or terminal diesease (e.g. cancer or tuberculosis)
- •Chronic disease which causes impairment of absorption, metabolism, secretion of study medication
- •Chronic hepatic disease or 3 fold increase in transaminases above normal
- •Positive HIV-testing (anamnestic survey)
- •Nursing women
- •Pregnancy (pregnacy testing in fertile women)
- •Fertile women with insufficient contraception
- •Participation in a different clinical trial less than 30 days before inclusion
- •Previous inclusion into BoTN-study
- •Parallel participation in a different clinical trial
研究者
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