Trial Designs for Evaluating Migraine Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Active drug for acute migraine treatment
DrugStandard dose of Sumatriptan 100 mg, which is used as an acute treatment for episodic migraine
Placebo Oral Tablet
DrugInactive placebo pill (100 mg) looking like the active drug
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Active groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Headache intensity
Headache intensity rated on a 11-point Numerical Rating Scale (("How intense is your headache right now?"; 0=no pain; 10=worst imaginable pain).
Time frame
Immediately before and 2 hours after each treatment administration2
Adverse events
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.
Time frame
2 hours after each treatment administrationSecondary outcomes
1
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 administration2
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
2 hours after each treatment administration3
Rescue medication
Use of rescue medication for episodic migraine (type of rescue medications, dose and time of administration) will be noted
Time frame
2 hours after each treatment administration4
Pain Freedom
Freedom from pain will be measured as yes/no.
Time frame
2 hours after each treatment administrationOther outcomes
1
Expectations
This parameter is measured as a predictor. Expectations are assessed using two 11-point numerical rating scales (NRSs) measuring expected headache intensity ("How intense do you expect your headache to be in two hours, once the pill has taken effect?"; 0 = no pain, 10 = worst pain imaginable) and expected treatment effect ("How effective do you expect the treatment to be?"; 0 = no treatment effect, 10 = best possible treatment effect)
Time frame
Immediately after each treatment administration2
Desire for pain relief
This parameter is measured as a predictor. Desire for pain relief is rated on a 11-point NRS ("How strong is your desire for pain relief from the treatment you just received?"; 0 = no desire, 10 = strongest possible desire)
Time frame
Immediately after each treatment administrationSponsors and contacts
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Source ClinicalTrials.gov