Migraine With AuraNCT06617832
Trial Designs for Evaluating Migraine Treatment
A study testing Active drug for acute migraine treatment in people with Migraine With Aura and Migraine Without Aura, run by University of Aarhus at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura, Headache, Migraine
- What is being tested?
- Active drug for acute migraine treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesDenmark
- Study dates
- 13 Nov 2024to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Dept. of Psychology and Behavioural Sciences
Aarhus C, 8000
Lene Vase, 004530614476, lenevase@psy.au.dk
- Recruiting
Department of Neurology, Aarhus University Hospital
Aarhus N, 8200
Sonja Antic, +457845 0000, Sonant@rm.dk
About this study
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.
Read the detailed description
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.
- Being tested
- Active drug for acute migraine treatment, Placebo Oral Tablet
- Keywords
- Headache, Episodic migraine, Randomized controlled trial, Balanced placebo design, Treatment effects, Adverse events
- Medical subject headings
- Migraine with Aura, Migraine without Aura, Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active drug for acute migraine treatmentDrug
Standard dose of Sumatriptan 100 mg, which is used as an acute treatment for episodic migraine
Placebo Oral TabletDrug
Inactive placebo pill (100 mg) looking like the active drug
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Active drug Receives: Drug: Active drug for acute migraine treatment |
| Placebo group | Placebo comparator | Inactive placebo Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately before and 2 hours after 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 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.
Measured: 2 hours after each treatment administration
Secondary outcomes (10)
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).
Measured: 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)
Measured: 2 hours after each treatment administration
Rescue medication
Use of rescue medication for episodic migraine (type of rescue medications, dose and time of administration) will be noted
Measured: 2 hours after each treatment administration
Pain Freedom
Freedom from pain will be measured as yes/no.
Measured: 2 hours after each treatment administration
Absence of the most bothersome migraine-associated 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.
Measured: 2 hours after 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).
Measured: 2 hours after each treatment administration
Most bothersome migraine-related symptom other than headache
Participants are asked to identify their most bothersome migraine-related symptom other than headache.
Measured: Immediately before each treatment administration
Presence of other migraine-related symptoms
Presence of other migraine-related symptoms, including nausea, vomiting, photophobia, phonophobia, or other symptoms is assessed dichotomously (yes/no).
Measured: 2 hours after each treatment administration
Desire for pain relief
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).
Measured: 2 hours after each treatment administration
Blinding
Participants indicate which treatment they believe to have received (sumatriptan or placebo), how certain they are on an 11-point NRS (0 = not at all certain, 10 = completely certain), and the reasons for this response (e.g., adverse events, symptom relief, characteristics of the pill or envelope, or other reasons).
After completion of all six treatment conditions, participants complete a single, retrospective assessment indicating which treatment they preferred overall or whether they perceived no meaningful difference between treatments. Participants are also asked to briefly describe the reasons for their preference.
Measured: 2 hours after each treatment administration and after completion of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start13 Nov 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded randomized controlled cross-over design where patients receive 1) sumatriptan or 2) placebo and are told that they receive a) sumatriptan or placebo, b) sumatriptan, or c) placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617832
- Sponsor's protocol ID
- UAarhus_Acute migraine
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the study, including demographic data, baseline characteristics, and outcome measures.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Designs for Evaluating Migraine Treatment
- ClinicalTrials.gov ID
- NCT06617832
- Acronym / sponsor ID
- UAarhus_Acute migraine
- Keywords
- Headache, Episodic migraine, Randomized controlled trial, Balanced placebo design, Treatment effects, Adverse events
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blinded randomized controlled cross-over design where patients receive 1) sumatriptan or 2) placebo and are told that they receive a) sumatriptan or placebo, b) sumatriptan, or c) placebo
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Drug: Active drug for acute migraine treatmentActive drug |
| Placebo group | Placebo comparator | Drug: Placebo Oral TabletInactive placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active drug for acute migraine treatmentStandard dose of Sumatriptan 100 mg, which is used as an acute treatment for episodic migraine | Drug | Active group |
| Placebo Oral TabletInactive placebo pill (100 mg) looking like the active drug | Drug | Placebo group |
Primary outcome
Headache intensity
Time frame: 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
Time frame: 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.
10 secondary outcomes
Positive and negative affect (PANAS)
Time frame: Before and 2 hours after each treatment administration
Functional disability scale
Time frame: 2 hours after each treatment administration
Rescue medication
Time frame: 2 hours after each treatment administration
Pain Freedom
Time frame: 2 hours after each treatment administration
Absence of the most bothersome migraine-associated symptom
Time frame: 2 hours after each treatment administration
Intensity of experienced adverse events
Time frame: 2 hours after each treatment administration
Most bothersome migraine-related symptom other than headache
Time frame: Immediately before each treatment administration
Presence of other migraine-related symptoms
Time frame: 2 hours after each treatment administration
Desire for pain relief
Time frame: 2 hours after each treatment administration
Blinding
Time frame: 2 hours after each treatment administration and after completion of the trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the study, including demographic data, baseline characteristics, and outcome measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active drug for acute migraine treatment in people with Migraine With Aura and Migraine Without Aura, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sigrid Juhl Lunde, MSc, PhD (4587165956, lunde@psy.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache intensity (time frame: Immediately before and 2 hours after each treatment administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.