DRKS00025934已完成2 期
Efficacy of erenumab in chronic cluster headache: A 10-week double-blind, randomized, placebo-controlled, multicentric trial - CAMG334ADE07T
Charité Campus Charité Mitte0 个研究点目标入组 101 人开始时间: 2021年8月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •During the Screening Epoch:
- •1) Patient is capable of understanding the nature, significance and implications of the clinical trial .Written informed consent must be obtained before any assessment is performed
- •2) Adult’s =18 and < 65 years of age upon entry into screening.
- •3) Documented history of chronic cluster headache for =12 months prior to screening according to the International Classification of Headache Disorders-3rd Edition (ICHD-3) listed below.
- •4) Insufficient efficacy OR tolerability OR contraindications of approved cluster headache prophylactic medications. Insufficient efficacy and tolerability as determined by the patient.
- •5) Sufficient acute attack treatment with triptans or oxygen based on the patient´s history
- •6) The patient is able to distinguish cluster headache attacks from other headaches (i.e. tension-type headaches).
- •During the Baseline Epoch:
- •7) This inclusion criteria should not be shared with potential patients:
- •At least 9 cluster headache attacks as defined by the ICHD-3 in 7 days during the baseline epoch (SPII), confirmed by patient-reported eDiary entries.
- •8) Attacks must have occurred on more than 50% of days of the baseline epoch (SPII).
- •9) = 90% patient-reported eDiary compliance during the Baseline epoch, compliance is measured as interacting with e-Diary at least once a day.
排除标准
- •1. Diagnosis or history of other primary headache diseases according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), excluding episodic tension type headache and migraine as defined in criterion 2.
- •2. Headache freedom from the historic diagnosis of migraine has to be at least one year prior to study inclusion. If patients have on average <=1 migraine attack per month within a year and can distinguish between migraine attacks and cluster attacks, they are allowed to participate.
- •3. Unable to differentiate cluster headache attacks from other headaches
- •4. Use of a prophylactic cluster headache medication within 5 half-lives prior to the start of the baseline phase; (see Table 5.1: Prohibited treatments)
- •5. Parallel use of an SPG stimulator, deep brain stimulation or parallel use of a device for the acute/preventive treatment of chronic cluster headache
- •6. Administration of botulinum toxin type A or B in the head or neck area, within 4 months of baseline (SP II) for treatment of cluster headache or other disorders, or for cosmetic use
- •7. Concurrent use of other therapeutic monoclonal antibodies. Prior use of other therapeutic antibodies is allowed if an adequate wash-out has occurred (=5 half-lives) prior to baseline (SP II)
- •8. Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- •9. Evidence of drug, opioid or alcohol abuse or dependence within 12 months prior to screening, based on medical records or patient self-report
- •10. History of use of psilocybin (mushrooms), LSD, MDMA or 2-bromo-LSD within 2 months prior to baseline (SPII)
- •11. Have a positive urine drug screen (UDS) for any substances of abuse, except cannabis or cannabinoids, prior to randomization. A retest is applicable if, in judgment of the investigator, there is a reasonable explanation for the positive result. A negative result in the retest is obligatory for entering baseline (SPII)
- •12. Diagnosis or history of significant active or unstable psychiatric disease, such as bipolar disorder, schizophrenia, personality disorders, or other serious mood or anxiety disorders. Patients with anxiety disorder and/or major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than one medication per disorder. Patients must have been on a stable dose within the 3 months prior to the start of the baseline phase.
- •13. Score yes” on item 4 or item 5 of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS), if this ideation occurred in the past month, or yes” on any item of the Suicidal Behavior section, except for the Non-Suicidal Self-Injurious Behavior” (item also included in the Suicidal Behavior section), if this behavior occurred in the past 3 months. Patients who do not meet this criterion, but who are considered by the judgment of the investigator to be at significant risk for suicide, must be excluded.
- •14. Active chronic pain syndromes (e.g., fibromyalgia or chronic pelvic pain), in which the pain has lost its guiding and warning function and has acquired an independent disease
- •15. History or current evidence of major psychiatric disorder (such as schizophrenia, bipolar disorder or type B personality disorder that might interfere with the ability to properly report clinical outcomes)
- •16. History or
研究者
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