EUCTR2005-004637-17-DE进行中（未招募）不适用
A Multicenter Study Evaluating the Efficacy and Safety of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Migraine Patients with 15 or More Headache Days per 4-Week Period in a 24-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase Followed by a 32-Week Open-Label Extension Phase
ALLERGAN LTD0 个研究点目标入组 650 人开始时间: 2006年8月29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
- 650
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 or female, 18 to 65 years old; history of migraine disorder as classified in ICHD-11 (2004) Section 1 [with the exception of hemiplegic migraine (1.2.4, 1.2.5) basilar migraine (1.2.6), ophthalmoplegic migraine (13.17) or migrainous infarction (1.5.4]; four or more headache episodes with a duration of at least 4 hours during the 4-week baseline period; fifteen or more headache days during the 4-week baseline period with each day consisting of at least 4 hours of continuous headache; written informed consent and data protection consent. Negative pregnancy test in females of childbearing potential
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Uncontrolled clinically significant medical condition other than the condition under evaluation (including alcohol/illicit substance abuse)
- •2.Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A Purified Neurotoxin Complex, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
- •3.Patients who have been diagnosed with the following headache disorders, as listed in ICHD-II (2004) section 1: complicated migraine (eg, hemiplegic migraine [1.2.4, 1.2.5], basilar migraine [1.2.6], ophthalmoplegic migraine [13.17] or migrainous infarction [1.5.4])
- •4.Use of any headache prophylactic medication within 28 days prior to Week -4
- •5.Headache diagnosis of chronic tension-type headache (ICHD-II 2.3), hypnic headache (ICHD-II 4.5), hemicrania continua (ICHD-II 4.7) or new daily persistent headache (ICHD-II 4.8)
- •6.Headache attributed to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
- •7.Unremitting headache lasting continuously throughout the 4-week baseline period
- •8.Patients with a known or suspected Temporomandibular Disorder (TMD), including pain in or around the Temporomandibular Joint (TMJ)
- •9.Patients with a concurrent diagnosis of fibromyalgia
- •10.Beck Depression Inventory score > 24 at Week -4
- •11.Psychiatric problems that, in the investigator’s opinion, are severe enough to interfere with study participation or results (eg, bipolar disorder)
- •12.Infection or skin disorder at anticipated injection sites
- •13.Females who are pregnant, nursing, or planning a pregnancy during the study
- •14.Females of childbearing potential, not using a reliable means of contraception
- •15.Previous treatment with botulinum toxin therapy of any serotype for any reason, or immunization to any botulinum toxin serotype
- •16.Anticipated need for botulinum toxin treatment for any reason during the study (other than study treatment)
- •17.Known allergy or sensitivity to the study medication or its components
- •18.Acupuncture, TENS (transcutaneous electrical nerve stimulation), cranial traction, nociceptive trigeminal inhibition or occipital nerve block treatments, or injection of anesthetics or steroids into the study target muscles within 4 weeks prior to Week -4 or , on or after Week -4
- •19.Previous participation in any botulinum toxin clinical trial
- •20.Concurrent enrollment in an investigational drug or device study or participation in such a study in the 30 days immediately prior to Week -4 or, on or after Week -4
- •21.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
- •22.The patient is not in the baseline phase (Week -4 to Day 0) for at least 28 days or does not record a minimum of 20 days worth of diary data
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