A randomized double blind controlled trial of Topiramate versus Propranolol in the prevention of chronic migraine: TOP-PRO STUDY
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Primary endpoints
研究概览
简要总结
Chronic migraine is a highly debilitating condition and the only FDA approved drug for its treatment is Botulinum toxin which is very costly and involves multiple injections over head and face. Recent studies have shown Topiramate to be effective in Chronic migraine. Propranolol is a safe and effective drug for episodic migraine and is cheaper than most other options. It has not been studied properly in chronic migraine patients however, in clinical practice it is widely used across various migraine groups with good effects. This study aims to study the effect of Propranolol in dose of 160 mg versus Topiramate 100 mg in a non inferiority design to establish its efficacy and safety. Our hypothesis is that Propranolol is similarly effective as Topiramate in chronic migraine patients and will provide a cheaper and time established safe and effective medication for sufferers of chronic migraine.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18-65 years, either male or female who fulfills the diagnostic criteria laid down by ICHD 3 for Chronic migraine and not on any prophylactic treatment.
排除标准
- •All patients with a clinical phenotype of CM but on further investigation, found to have a secondary cause for their headaches will be excluded.
- •Pregnant women, patient with known allergies against propranolol and/or topiramate, patients with history of bronchial asthma, Chronic obstructive pulmonary disease (COPD), diabetes, bradycardia or heart blocks, congestive heart failure (CHF), glaucoma, renal stones, dementia, psychosis and severe depression shall be excluded from the study.
结局指标
主要结局
Primary endpoints
时间窗: It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial.
1. Change in migraine days per 28 days (Migraine day is defined as a calendar day
时间窗: It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial.
for migraine)
时间窗: It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial.
when the patient reported ≥4 continuous hours of headache meeting ICHD 3 criteria
时间窗: It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial.
次要结局
- A. Frequency parameters(1. Change in headache days per 28 days (Headache day is defined as a calendar day)
- B. Severity parameters(1. Change in average Visual analogue scale (VAS) score at the end of each month.)
- C. Adverse events(It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial.)
- D. Impact on headache disorder and associated disability(1. Headache Impact Test (HIT))