EUCTR2018-001228-20-DE进行中（未招募）1 期
A 12-month prospective, randomized, interventional, global, multi-center, active-controlled study comparing sustained benefit of two treatment paradigms (erenumab qm vs. oral prophylactics) in adult episodic migraine patients
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adults =18 of age upon entry into screening.
- •- Documented history of migraine (with or without aura) =12 months prior to screening.
- •- =4 and <15 days per month of migraine symptoms (based on ICHD-3 criteria) on average across 3 months prior to screening based on retrospective reporting.
- •- <15 days per month of headache symptoms (i.e., migraine and non-migraine)
- •- Subjects in need for switching by documented failure of 1 or 2 prophylactic therapies in the last 6 months due to either lack of efficacy or poor tolerability (see list of prophylactic therapies in Exclusion Criteria 6 and definition for lack of efficacy and poor tolerability). For subjects with 1 prior treatment failure, the failure should have occurred in the last 6 months. For subjects with 2 prior treatment failures, the
- •second treatment failure should have occurred in the last 6 months.?
- •- During baseline period, confirmed migraine frequency of 4 to 14 migraine days and <15 days of headache symptoms.
- •- During baseline period, =80% compliance with the headache diary.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Older than 50 years of age at migraine onset.
- •- Lack of efficacy or poor tolerability with > 2 treatments from the following 7 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are:
- •Category 1: Divalproex sodium, sodium valproate
- •Category 2: Topiramate
- •Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol)
- •Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)
- •Category 5: Serotonin-norepinephrine reuptake inhibitors (for example: venlafaxine, desvenlafaxine, duloxetine, milnacipran)
- •Category 6: Flunarizine, verapamil
- •Category 7: Lisinopril, candesartan
- •Efficacy failure is defined as no meaningful reduction in headache frequency, duration, and/or severity after administration of the medication for at least 6 weeks at the generally accepted therapeutic dose(s) based on the investigator's assessment.
- •Tolerability failure is defined as documented discontinuation due to adverse events of the respective medication during the last 6 months prior to screening.
- •The following scenarios do not constitute lack of therapeutic response:
- •--Lack of sustained response to a medication
- •--Patient decision to halt treatment due to improvement
- •-Used a prohibited medication from the 7 categories of prior prophylactic medications within 3 months prior to start of and during baseline for a non-migraine indication if dose is not stable.
- •- Taken the following for any indication in any month during the 2 months prior
- •to the start of the baseline period:
- •?-- Ergotamines or triptans on = 10 days per month, or
- •?-- Simple analgesics (non-steroidal anti-inflammatory drugs [NSAIDs],
- •acetaminophen) on = 15 days per month, or
- •?-- Opioid- or butalbital-containing analgesics on =4 days per month
- •-Device, or procedure that potentially may interfere with the intensity or number of migraine days within 2 months prior to the start of or during baseline
- •-Previous exposure to erenumab or exposure to any other prophylactic CGRP-targeted therapy prior to the study.
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