Head-to-head Study of Erenumab Against topiRamate-a Double-blind, Double Dummy Migraine Study to Assess Tolerability and Efficacy in a patiEnt -Centered Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 777
- 试验地点
- 1
- 主要终点
- Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE)
研究概览
简要总结
This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve or not suitable for or could have failed up to three prophylactic treatments out of: propranolol/metoprolol, amitriptyline, flunarizine. Patients were stratified into groups according to their number of migraine days during the baseline period.
详细描述
All patients completing the Baseline period and fulfilling baseline eligibility criteria were invited to participate to the Double-blind, double-dummy Treatment Epoch (DBTE, 24 weeks) .
Eligible patients were randomized to one of two treatment arms. DBTE started with a titration phase for topiramate of a maximum of 6 weeks to determine the maximal tolerated dose and aimed to reach the recommended treatment dose of 100 mg according to the German SmPC. After the titration phase, maintenance phase started (18 weeks). Topiramate dose had to be maintained until the end of the DBTE. Erenumab dose at beginning of the DBTE was determined patient individually by the investigator based on the guidance provided in the SmPC and was either 70 mg or 140 mg. Dose escalation from 70 mg to 140 mg in case of insufficient response was considered at anytime during the DBTE.
Dose reduction of topiramate and erenumab was not allowed during DBTE (Week 0 to Week 24). After Week 24 or if the patient discontinued study drug, a one week double-blind taper off phase followed to ensure proper down titration for topiramate. At the end of the DBTE (24 weeks) the final assessment occurred to address the objectives.
A Follow-Up Visit 4 weeks after last study visit (or 8 weeks after last IMP injection for discontinued patients) was required as part of routine safety monitoring. The primary analysis was triggered when all patients had completed their respective last visit of the DBTE.
The End of study occurred when the last patient completed last visit (LPLV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of migraine in the 12 months prior to screen
- •at least 4 days per month of migraine symptoms
- •>=80% diary compliance during the Baseline period
- •Patients must be either naïve or not suitable or have failed previous migraine prophylactic treatments
排除标准
- •Older than 50 years of age at migraine onset
- •Pregnant or nursing
- •History of cluster or hemiplegic headache
- •History or evidence of major psychiatric disorder
- •Score of 19 or higher on Beck Depression Inventory (BDI)
研究组 & 干预措施
Erenumab
70 mg and 140 mg Erenumab
干预措施: Erenumab (Biological)
Erenumab
70 mg and 140 mg Erenumab
干预措施: Erenumab matching placebo (Biological)
Topiramate
Topiramate in the highest tolerated dose (50 - 100 mg/day)
干预措施: Topiramate (Drug)
Topiramate
Topiramate in the highest tolerated dose (50 - 100 mg/day)
干预措施: Topiramate matching placebo (Drug)
结局指标
主要结局
Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE)
时间窗: 24 Weeks
The primary objective was to demonstrate the tolerability of 70 mg and 140 mg erenumab compared to topiramate in the highest tolerated dose assessed by the rate of patients discontinuing treatment due to AE during the double-blind epoch of the study.
次要结局
- Number of Patients With at Least 50% Reduction From Baseline in Monthly Migraine Days (MMD) Over the Last Three Months (Month 4, 5, and 6)(Baseline, Last three months (month 4, 5, and 6))