CTRI/2023/04/051913尚未招募3 期
GREATER OCCIPITAL NERVE BLOCK WITH AND WITHOUT STEROIDS FOR CHRONIC MIGRAINE (GONBLOCK-FOR-CM): A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY - GONBLOCK-FOR-CM
GB Pant Institute of Post Graduate Medical Education and Research0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1.Adults 18 to 65 years of age who had have a history of migraine with or without aura (as defined by ICHD-3) for at least 12 months before screening.
- •2.Patients should be experiencing >=15 days/month of headache for more than 3 months, having features of migraine headache on at least 8 days/month (as obtained by history from the patient).
- •3.Patients should be experiencing headache >=15 days/4 weeks, having features of migraine headache on at least 8 days/4 weeks during the baseline the phase (as recorded by headache diary)
- •4.Patients must demonstrate at least 80% adherence to reporting with the headache diary during the baseline phase.
- •5.Patients with medication overuse [overuse of triptans, ergot derivatives, analgesics, and combination drugs (any combination of those above or simple analgesics with opiates or butalbital)] will be permitted to participate in this study.
排除标准
- •1.Patients older than 50 years at migraine onset
- •2.Patients will be excluded if they had no therapeutic response in migraine prevention after an adequate therapeutic trial of >=3 of the following medication categories: Category 1: Divalproex sodium, sodium valproate; Category 2: Topiramate; Category 3: Beta blockers; Category 4: Tricyclic antidepressants; Category 5: Serotonin-norepinephrine reuptake inhibitors; Category 6: Flunarizine, verapamil; Category 7: Lisinopril, candesartan; 8 Botulinum toxin; 9 GONB. (No therapeutic response will be defined as no reduction in headache frequency, duration, or severity after administration of the medication for >=6 weeks at the generally accepted therapeutic dose(s) based on the investigatorâ??s assessment. Lack of sustained response to a medication and failure to tolerate a therapeutic dose will not considered to be â??no therapeutic response.â??)
- •3.Patients who received Botulinum toxin (in the head and/or neck region) is excluded within 4 months before the start of the baseline phase and throughout the study.
- •4.Devices and procedures such as GONB used for migraine prophylaxis are excluded within 4 months before the start of the baseline phase and throughout the study.
- •5.Investigational medications and devices are excluded throughout the study.
- •6.Patients also must not have used investigational medications or devices for at least 90 days prior to baseline phase.
- •7.All patients with a clinical phenotype of chronic migraine but on further investigation, found to have a secondary cause for their headaches will be excluded.
- •8.Pregnant women, patient with known allergies against lidocaine or methylprednisolone, patients with history of moderate to severe anxiety or depression, psychosis and chronic liver, kidney and heart diseases shall be excluded from the study.
研究者
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