EUCTR2020-004399-16-DE进行中（未招募）1 期
Efficacy of erenumab in chronic cluster headache: A 10-week double-blind, randomized, placebo-controlled, multicentric trial - CAMG334ADE07T
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 118
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
- •During Screening:
- •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)
- •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 Baseline:
- •6)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.
- •Attacks must have occurred on more than 50% of days of the baseline epoch (SPII).
- •7)= 90% patient-reported eDiary compliance during the Baseline epoch, compliance is measured
- •as interacting with e-Diary at least once a day
- •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 118
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Diagnosis or history of other primary headache diseases including the diagnosis of episodic cluster headache according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), excluding episodic tension type headache.
- •Use of a prophylactic cluster headache prophylaxis medication within 5 half-lives prior to the start of the baseline phase. (specified in Table 5.1)
- •Parallel use of an SPG stimulator or parallel use of a device for the acute/preventive treatment of cCH;
- •Significant comorbidities or psychiatric disorders, drug abuse or opioid use
- •Diagnosis or history of severe psychiatric or personality disorder
- •Concurrent use of other therapeutic monoclonal antibodies
- •Diagnosis of chronic or active hepatitis
研究者
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