CTRI/2023/04/051915尚未招募3 期
Role of Brivaracetam use for Treatment of Episodic Migraine (ROBUST-EM): A Randomised Double-Blind Placebo-Controlled Studyâ??. - ROBUST-EM
GB Pant Institute of Post Graduate Medical Education and Research, New Delhi 1100020 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 at least 4 and fewer than 15 migraine headache days during the 4weeks of the baseline phase (as obtained by the paper headache diary).
- •3.Patients should be experiencing fewer than 15 headache days per month during the last 3 months before baseline the phase (as obtained by history from the patient).
- •4.Patients must demonstrate at least 80% adherence to reporting with the headache diary during the baseline phase.
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 >2 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. (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.The following medications, devices, or procedures will be excluded: 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.Ergotamine derivatives, steroids, and triptans used for migraine prophylaxis are excluded within 3 months before the start of the baseline phase and throughout the study.
- •5.Devices and procedures used for migraine prophylaxis are excluded within 2 months before the start of the baseline phase and throughout the study. 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 screening.
- •7.Patients who were concomitantly using medications for migraine prevention within 3 months before the start of the baseline phase and throughout the study will be excluded.
- •8.Patients with significant suicidal ideation as analysed by Columbia Suicide Severity Rating Scale (C-SSRS) >2
- •9.Pregnant women, female patients who are not willing for effective contraception.
- •10.Patient with known allergies against levetiracetam or brivaracetam, 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
相似试验
尚未招募
不适用
Therapeutic range of Brivaracetam, a historical observational study to define a therapeutic rangeG40.2G40Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizuresEpilepsyDRKS00012584Epilepsiezentrum Kork200
尚未招募
Unknown
Comparison of effectiveness and side effects of Brivaracetam and Levetiracetam in head injury patientsCTRI/2023/11/059371Gmc neurosurgery dept goa
尚未招募
Unknown
Brivaracetam drug in treating epilepsyCTRI/2024/06/068495Torrent Pharmaceuticals Ltd.
已完成
2 期
Clinical Efficacy of Piracetam on the Treatment of Breath _Holding SpellsBreath-holding spells.Other and unspecified abnormalities of breathingIRCT138801231808N1Mazandaran University of Medical Sciences and Health Services50
已完成
2 期
A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit SettingEpilepsyNCT03021018UCB Biopharma S.P.R.L.46