CTRI/2015/05/005829已完成4 期
Topical betablockers(Timolol ophthalmic solution 0.5 %) in acute migraine-a prospective randomised crossover trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Treatment Success with Timolol eyedrops assessed by the alleviation of pain as assessed by a decrease in pain score by the numerical pain rating scale for each attack
研究概览
简要总结
This is a prospective, randomised, double blind, single centre, placebo controlled crossover trial comparing the efficacy and safety of topical timolol 0.5% eyedrops in patients with acute migraine.
Primary outcome measures will be treatment success defined as a decrease in pain score on a numerical pain scale by the patient before and after treatment for the acute attack.
The secondary outcomes will be the assessment for safety indices at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male of female patients at least 12 years of age.
- •2.Female of childbearing potential should use a reliable form of contraception throughout the study period.
- •3.A negative urine pregnancy test result at Enrolment on Day 1 for women of childbearing potential.
- •4.Written informed consent to be obtained.
- •5.Clinical diagnosis of migraine -Migraine with aura(1.1), Migraine without aura(1.2), Probable Migraine without aura(1.5.1) or Probable Migraine with aura(1.5.2) according to the ICHD III diagnostic criteria.
- •6.Not be on any antimigraine medications for atleast 1 month.
- •7.Ability to understand and follow the study instructions you receive and willingness for 7 months followup.
排除标准
- •1.Known Allergy or hypersensitivity to the study medications.
- •2.Female patients who are pregnant, Breastfeeding, or planning to become pregnant during the study.
- •3.Females in childbearing age who are not using a reliable means of contraception 4.Patients with Bronchial Asthma, Bradyarrhythmias and cardiac dysfunction 5.Patients with coexistent Glaucoma, in whom use of topical Betablockers is anticipated.
- •6.Patients not amenable to a minimum followup of 7 months 7.Patients on medications for migraine, who were not willing to stop existing treatment for atleast 1 month.
- •8.Obstruction of lacrimal drainage system detected on baseline evaluation.
- •9.Current enrolment in another investigational study or participation in such a study within 30 days of entry into this study.
- •10.Patient has a condition or situation which in the investigators opinion, may put the patient at a significant risk, may confound the study results, or interfere with the participation in the study.
结局指标
主要结局
Treatment Success with Timolol eyedrops assessed by the alleviation of pain as assessed by a decrease in pain score by the numerical pain rating scale for each attack
时间窗: On study completion (at 7 months)
次要结局
- Assessment of Safety indices like BCVA, IOP, Slit Lamp Biomicroscopy, General and Systemic examination(At each visit after baseline Day15, Month1, Month2, Month3, Month4, Month5, Month6, Month7)
研究者
研究点 (1)
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