New Methods for Evaluating Preventive Migraine Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Mean change in headache intensity
研究概览
简要总结
The study aims to test interactions between drug and placebo-responses in acute migraine treatment and to assess variation in adverse events according to treatment information provided. Using a clinical within-subjects, balanced placebo design, patients with chronic migraine will receive four treatment conditions in a randomized order.
详细描述
The existing paradigm for testing the effect of treatment is the double-blind randomized controlled trial (RCT) comparing an active drug to an inactive placebo. This comparison is done in order to control for contextual and psychological factors such as the patients' treatment expectations - a key factor in placebo responses. However, recent studies have indicated that some assumptions underlying the RCT may be incorrect and may lower the assay sensitivity and miscalculate the actual drug response. The so-called balanced placebo design (BPD) targets some of the shortcomings of the RCT by balancing the information given to the patients with the actual treatment administered. In this project, patients suffering from chronic migraine will receive a total of 4 injections over 8 months. Half of them are femanezumab, while the other half are placebo (an inactive injection). The injections (fremanezumab and placebo) look the same, and neither the patient nor the investigator know which injection will be administered. The order will be randomized. The injections are given with different information about what the patients are receiving. To avoid a carry-over effect, the patients will receive one injection every second month. The first month will be without treatment whereupon the patient will receive the first injection. During the first 28 days before and after each administration, patients rate outcome measures in an electronic pain/headache diary at home. In addition, they will also fill out questionnaires assessing their quality of life, psychological parameters and the headache burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Adults (18-65 years)
- •≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria
- •Known chronic migraine (headache occurring ≥ 15 days per month for > 3 months, which on at least 8 days per month has the features of migraine headache) diagnosed before age 65
- •Eligibility for preventive migraine treatment
- •Ability to speak and read Danish
排除标准
- •Use of onabotulinumtoxinA as preventive migraine treatment during the 4 months before inclusion
- •Use of other preventive migraine treatment except CGRP antagonists (However, participants are allowed to be on two stable preventive medication (antidepressant, calcium channel blockers, beta blockers or antiepileptic)- 2 months prior to inclusion until end of study), devices for migraine prevention such as transcranial magnetic stimulation and use of nerve blocks 3 months prior to inclusion
- •Use of opioid or barbiturate medications in the last four weeks before inclusion
- •Secondary headache disorders including medication overuse headache
- •Severe psychiatric, vascular disease, or known liver disease
- •Alcohol abuse or substance abuse
- •Current or planned pregnancy and lactation
研究组 & 干预措施
Active group
Active drug
干预措施: Active drug for chronic migraine treatment. (Drug)
Placebo group
Inactive placebo
干预措施: Placebo Subcutaneous injection (Drug)
结局指标
主要结局
Mean change in headache intensity
时间窗: Measured every day during the 8 month trial period
Headache intensity rated on a 11-point Numerical Rating Scale (0=no pain; 10=worst pain intensity) measured 28 days before and after each treatment administration.
Mean change in moderate/severe headache days
时间窗: Measured every day during the 8 month trial period
Total number of moderate/severe headache days will be measured 28 days before and after each treatment administration. Moderate/severe headache days will be recorded by the presence of headache (yes/no), peak pain intensity (mild/moderate/severe), and duration (\< 4h or ≥ 4h), as well as acute medication intake and treatment response.
Moderate/severe headache days
时间窗: Through study completion, an average of 8 months
Total number of moderate/severe headache days will be measured 28 days before and after each treatment administration. Headache days will be recorded by the presence of headache (yes/no), peak pain intensity (mild/moderate/severe), and duration (\< 4h or ≥ 4h), acute medication intake type (triptan/ergotamine/other) and migraine associated symptoms.
Headache/pain intensity
时间窗: 8 months
Headache/pain intensity rated on a 11-point Numerical Rating Scale (0=no pain; 10=worst pain intensity) will also be measured 28 days before and after each treatment administration.
Adverse events
时间窗: 24 hours, 14 and 28 days after each treatment administration
Occurrence of adverse events in each treatment condition recorded by the presence of adverse events ascribed to the treatment, measured using free recall and prompting. For each prompted symptom, participants respond "yes" or "no" and indicate whether they believe the symptom is related to the medication, the migraine attack, or another cause.
次要结局
- Migraine days(Measured every day during the 8 month trial period)
- Acute treatment utilization(Measured every day during the 8 month trial period)
- Blinding(28 days after each treatment administration and after completion of the trial)
- Intensity of migraine(Through study completion, an average of 8 months)
- Acute treatment utilization(Through study completion, an average of 8 months)
- Hospital Anxiety and Depression Scale (HADS)(Pre-treatment and 28 days after each treatment administration)
- HIT-6(Pre-treatment and 28 days after each treatment administration)
- Migraine days(Through study completion, an average of 8 months)
- Positive and negative affect (PANAS)(Pre-treatment and 28 days after each treatment administration)
- Intensity of experienced adverse events(24 hours, 14 days and 28 days after each treatment administration)
- Quality of life (SF-12)(Pre-treatment and 28 days after each treatment administration)