New Methods for Evaluating Preventive 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, balanced placebo design, patients with chronic migraine will receive four 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 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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Active drug for chronic migraine treatment.
DrugStandard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously
Placebo Subcutaneous injection
DrugInactive placebo (saline) injected subcutaneously in the same volume as the active drug
Treatment groups
60 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
Mean change in headache intensity
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.
Time frame
Measured every day during the 8 month trial period2
Mean change in moderate/severe headache days
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.
Time frame
Measured every day during the 8 month trial period3
Adverse events
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.
Time frame
24 hours, 14 and 28 days after each treatment administrationSecondary outcomes
1
Migraine days
Total number of migraine days will be measured 28 days before and after each treatment condition.
Time frame
Measured every day during the 8 month trial period2
Acute treatment utilization
The use of acute migraine medication will be recorded, including the specific drug used, number of days and dose.
Time frame
Measured every day during the 8 month trial period3
Positive and negative affect (PANAS)
PANAS will be used to measure positive and negative emotions or feelings pre- and post-treatment of each treatment condition. 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
Pre-treatment and 28 days after each treatment administration4
Hospital Anxiety and Depression Scale (HADS)
It is a 14-item measure designed to assess anxiety and depression symptoms. It is rated on a 4-point Likert scale. It will be measured pre- and post-treatment of each treatment condition.
Time frame
Pre-treatment and 28 days after each treatment administrationOther outcomes
1
Expectations
This parameter is measured as a predictor using four 11-point NRS scales: expected headache intensity ("How intense do you expect your headache to be during the coming week?"; 0 = no pain, 10 = worst imaginable), expected improvement (0 = none, 10 = greatest possible), expected worsening (0 = none, 10 = greatest possible), and expected adverse events ("To what extent do you expect symptoms/adverse effects?"; 0 = not at all, 10 = greatest possible). Pre-treatment ratings reflect general expectations for the next 7 days. Post-treatment ratings use the same items but refer to expectations as a result of the received treatment. Immediately after each treatment, expectations are also assessed with the same four scales, focusing on the coming 28 days in relation to that treatment.
Time frame
Weekly throughout the study period and immediately after each treatment administration2
Desire for headache relief
This parameter is measured as a predictor. Desire for headache relief is assessed using an 11-point ("How strong is your desire for headache relief from the treatment"; 0 = no desire, 10 = strongest possible desire).
Time frame
28 days before treatment administration and immediately after treatment administrationSponsors and contacts
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Source ClinicalTrials.gov