Trial Designs for Evaluating Migraine Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- 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, advanced balanced placebo design, patients with episodic migraine will receive six treatment conditions in a randomized order.
详细描述
The existing paradigm for testing the effect of treatments 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 study results 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 the shortcomings of the RCT by balancing the information given to the patients (correct or false) with the actual treatment administered (active treatment or placebo). In this project, the aim is to examine whether the active drug response and the placebo response interact in acute migraine treatment.
Patients suffering from episodic migraine will go through six treatment conditions in randomized order. They will receive acute migraine treatment (a sumatriptan pill) or inactive treatment (a placebo pill) in the event of a developing migraine attack. Using a clinical within-subjects design, the patients receive 1) sumatriptan or 2) placebo and are told that they receive a) sumatriptan or placebo, b) sumatriptan, or c) placebo. All treatments and accompanying treatment descriptions will be administered at home.
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 episodic migraine (≥ 1 and < 15 headache days with features of migraine on at least 2-8 days per month for > 3 months) with and without aura and diagnosed before age 50
- •Previous or active use of triptans as acute treatment for migraine
- •Ability to speak and read Danish
排除标准
- •Chronic migraine or history of chronic migraine in the last 12 months
- •Other concomitant primary headache types except for infrequent tension-type headache
- •Secondary headache disorders including medication overuse headache
- •Severe psychiatric, vascular or liver diseases
- •Opioid or barbiturate use in the month preceding screening
- •Current use of preventive migraine treatment (i.e., onabotulinum toxin A, and/or Calcitonin gene-related peptide (CGRP) monoclonal antibodies) (however, stable medical treatment with other migraine prophylactic agents is permitted, e.g. antidepressant, calcium channel blockers, beta blockers and antiepileptic drugs, 4 weeks prior to inclusion until the completion of participation in the study)
- •Contraindications or inability to tolerate triptans
- •Current substance use disorder
- •Implanted metallic or electronic device in the head
- •Cardiac pacemaker or implanted or wearable defibrillator
- •Use of illegal psychotropic drugs less than a week before participation in the study; regarding cannabis: less than four weeks before participation in the study
- •Current pregnancy or planned pregnancy (confirmed by pregnancy test and by use of safe contraception as defined by the Danish Medicines Agency) and lactation
研究组 & 干预措施
Active group
Active drug
干预措施: Active drug for acute migraine treatment (Drug)
Placebo group
Inactive placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Headache intensity
时间窗: 2 hours from each treatment administration
Headache intensity rated on a 11-point Numerical Rating Scale (0=no pain; 10=worst imaginable pain) 2 hours after each treatment condition.
Adverse events
时间窗: 2 hours from each treatment administration
Occurrence of adverse events in each treatment condition recorded by the presence of adverse events ascribed to the treatment, measured by free recall and by prompting.
Headache intensity
时间窗: Immediately before and 2 hours after each treatment administration
Headache intensity rated on a 11-point Numerical Rating Scale (("How intense is your headache right now?"; 0=no pain; 10=worst imaginable pain).
Adverse events
时间窗: 2 hours 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 structured prompting (fatigue/drowsiness, nausea/vomiting, altered taste, feeling of warmth, flushing, feeling of cold, heaviness, muscle pain, chest pain/pressure, tingling sensations, dizziness, shortness of breath, or any other adverse event/symptom). 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
- Functional disability scale(2 hours after each treatment administration)
- Rescue medication(2 hours after each treatment administration)
- Pain Freedom(2 hours after each treatment administration)
- Absence of the most bothersome migraine-associated symptom(2 hours after each treatment administration)
- Intensity of experienced adverse events(2 hours after each treatment administration)
- Most bothersome migraine-related symptom other than headache(Immediately before each treatment administration)
- Presence of other migraine-related symptoms(2 hours after each treatment administration)
- Desire for pain relief(2 hours after each treatment administration)
- Blinding(2 hours after each treatment administration and after completion of the trial)
- Positive and negative affect (PANAS)(Before and 2 hours after each treatment administration)
- Functional disability scale(Before and 2 hours after each treatment administration)
- Rescue medication(2 hours from each treatment administration)
- Pain Freedom(2 hours from each treatment administration)
- Absence of the most bothersome symptom(2 hours from each treatment administration)
- Intensity of experienced adverse events(2 hours (from each treatment administration))