The study aims to estimate treatment effects in randomized controlled trials (RCT) and a balanced placebo design (BPD) to specify how contextual and psychological factors interact in acute migraine treatment and influence adverse event occurrence. Using a clinical within-subjects design, patients with episodic migraine will receive six treatment conditions in a randomized order.
The existing paradigm for testing the effect of treatments is the double-blind 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 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 if the magnitude of the drug effect differs when estimated based on the RCT design and when based on BPD, conditioning on the information provided to the recipient. Additionally, it will also be tested if 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
128
Standard dose of Sumatriptan 100 mg, which is used as an acute treatment for episodic migraine
Inactive placebo pill (100 mg) looking like the active drug
Dept. of Psychology and Behavioural Sciences
Aarhus C, Denmark
NOT_YET_RECRUITINGDepartment of Clinical Medicine, Aarhus University Hospital
Aarhus N, Denmark
RECRUITINGHeadache intensity
Headache intensity rated on a 11-point Numerical Rating Scale (0=no pain; 10=worst imaginable pain) 2 hours after each treatment condition.
Time frame: 2 hours from each treatment administration
Adverse events
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.
Time frame: 2 hours from each treatment administration
Positive and negative affect (PANAS)
PANAS will be used to measure positive and negative emotions or feelings in the present moment. Positive affectivity refers to positive emotions and expressions. Negative affectivity, on the other hand, refers to negative emotions and expressions. This scale consists of words that describe different emotions and is scored on a likert scale ranging from 1 to 5 (1= Very slightly or Not at all, 2=little, 3=moderately, 4=quite a bit and 5 =extremely).
Time frame: Before and 2 hours after each treatment administration
Functional disability scale
Functional disability due to migraine will be measured on a 4-point scale (0= no disability (i.e., able to function normally); 1=mild disability (i.e., able to perform all activities of daily living but with some difficulty); 2=moderate disability (i.e., unable to perform certain activities of daily living); 3=severe disability (i.e., unable to perform most to all activities of daily living or requiring bed rest)
Time frame: Before and 2 hours after each treatment administration
Rescue medication
Use of rescue medication for episodic migraine (type of rescue medications and time of administration) will be noted
Time frame: 2 hours from each treatment administration
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Pain Freedom
Freedom from pain will be measured as yes/no at 2 hours after each treatment condition
Time frame: 2 hours from each treatment administration
Absence of the most bothersome symptom
Absence of the most bothersome migraine-associated symptoms such as nausea, vomiting, photophobia, and phonophobia. The participants are asked to answer the question by answering yes or no.
Time frame: 2 hours from each treatment administration
Intensity of experienced adverse events
Intensity of the experienced adverse events will be measured on a 11-point Numerical Rating Scale (e.g., "To what extent have you been feeling fatigue/dizziness?"; 0=not at all; 10=worst imaginable)
Time frame: 2 hours (from each treatment administration)