CTIS2023-504839-40-00招募中1 期
A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport for the Prevention of Episodic Migraine in Adult Participants - CLIN-52120-464
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participant must be =18 years of age inclusive, at the time of signing the informed consent and privacy/data protection documentation., Participant has a diagnosis for more than 12 months, prior to screening visit, of migraine with aura or migraine without aura according to the International Classification of Headache Disorders definition and diagnostic criteria, Migraine onset occurred when participant was <50 years of age, Has baseline number of monthly headache days (MHD) of <15 and baseline number of monthly migraine days (MMD) of =6, using eDiary data collected during the 4 weeks nearest to randomisation on Day 1 (but prior to randomisation)., Has baseline number of valid diary days =22 days collected during the 4 weeks nearest to randomisation on Day 1.
排除标准
- •History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache., Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache, which is permitted., Use of any of the following medications in the specified timeframe prior to start of completion of the screening daily headache eDiary: a. Within 24 weeks i. Botulinum toxin for migraine (or for any other medical/aesthetic reason within 16 weeks) b. Within 12 weeks i. CGRP antagonists (monoclonal antibody or gepant) for preventive treatment of migraine (acute treatment of headache/migraine with a gepant is permitted, but limited to no more than six days per month (i.e. 6 days per each 4-week period with gepant intake)). ii. Cannabinol or other types of cannabinoids c. Within 4 weeks i. Anaesthetic or steroid injection in any region targeted for injection with study intervention ii. Use of medical device to treat migraine (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation) iii. Other interventions for migraine assessed to interfere with study evaluations (e.g. acupuncture in head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments, and dental splints for headache) iv. Use of opioids or barbiturates for more than 2 days/month.
研究者
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