MigraineNCT07071506
New Methods for Evaluating Preventive Migraine Treatment
A study testing Active drug for chronic migraine treatment. in people with Migraine and Migraine With or 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, Migraine With or Without Aura, Headache Disorders
- What is being tested?
- Active drug for chronic migraine treatment.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- 19 Jun 2025to 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 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
- Ability to speak and read Danish
Who cannot join
- 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
- Severe psychiatric, vascular disease, or known liver disease
- Alcohol abuse or substance abuse
- Current or planned pregnancy 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
- Recruiting
Department of Psychology and Behavioral sciences, Aarhus BSS, Aarhus University
Aarhus C, Denmark, 8000
Lene Vase, +4587165828, lenevase@psy.au.dk
- Recruiting
Department of Neurology, Aarhus University Hospital
Aarhus N, Denmark, 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, balanced placebo design, patients with chronic migraine will receive four treatment conditions in a randomized order.
Read the detailed description
The existing paradigm for testing the effect of treatment 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 studies 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 some of the shortcomings of the RCT by balancing the information given to the patients with the actual treatment administered. In this project, patients suffering from chronic migraine will receive a total of 4 injections over 8 months. Half of them are femanezumab, while the other half are placebo (an inactive injection). The injections (fremanezumab and placebo) look the same, and neither the patient nor the investigator know which injection will be administered. The order will be randomized. The injections are given with different information about what the patients are receiving. To avoid a carry-over effect, the patients will receive one injection every second month. The first month will be without treatment whereupon the patient will receive the first injection. During the first 28 days before and after each administration, patients rate outcome measures in an electronic pain/headache diary at home. In addition, they will also fill out questionnaires assessing their quality of life, psychological parameters and the headache burden.
- Being tested
- Active drug for chronic migraine treatment., Placebo Subcutaneous injection
- Keywords
- Headache, Chronic migraine, Balanced placebo design, Treatment effects, Adverse events
- Medical subject headings
- Migraine Disorders, Headache Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active drug for chronic migraine treatment.Drug
Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously
Placebo Subcutaneous injectionDrug
Inactive placebo (saline) injected subcutaneously in the same volume as the active drug
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Active drug Receives: Drug: Active drug for chronic migraine treatment. |
| Placebo group | Placebo comparator | Inactive placebo Receives: Drug: Placebo Subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured every day during the 8 month trial period
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.
Measured: Measured every day during the 8 month trial period
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.
Measured: 24 hours, 14 and 28 days after each treatment administration
Secondary outcomes (8)
Migraine days
Total number of migraine days will be measured 28 days before and after each treatment condition.
Measured: Measured every day during the 8 month trial period
Acute treatment utilization
The use of acute migraine medication will be recorded, including the specific drug used, number of days and dose.
Measured: Measured every day during the 8 month trial period
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).
Measured: Pre-treatment and 28 days after each treatment administration
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.
Measured: Pre-treatment and 28 days after each treatment administration
Quality of life (SF-12)
Short-form-12 (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It consists of two components- physical (PCS-12) and mental (MCS-12). The summary scores are scored using norm-based scoring, where means of 50 and standard deviations of 10 are achieved.
Measured: Pre-treatment and 28 days after each treatment administration
HIT-6
Headache impact test (HIT-6) measures the impact that headache has on social functioning, role functioning, vitality, cognitive functioning, and psychological distress. It consists of 6 questions. Each question can be answered with 5 responses (never, rarely, sometimes, very often, or always), which has the following numerical values (6, 8, 10, 11, and 13, respectively).
Measured: Pre-treatment and 28 days 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: 24 hours, 14 days and 28 days after each treatment administration
Blinding
At the end of each treatment condition, participants indicate which treatment they believe to have received (fremanezumab 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 injection, or other reasons). After completion of all four treatment conditions, participants complete a single, retrospective assessment indicating which treatment they preferred overall. Participants are also asked to briefly describe the reasons for their preference.
Measured: 28 days 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 posted17 Jul 2025
- Study start19 Jun 2025
- 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 MigraineStudies 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\) Fremanezumab or 2) placebo, twice.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lene Vase, MSc, PhD, DMSc, Principal investigator, Dept. of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071506
- Sponsor's protocol ID
- UAarhus_Chronic migraine
- Status last verified
- Apr 2026
- First submitted
- 28 May 2025
- Last updated
- 19 May 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Methods for Evaluating Preventive Migraine Treatment
- ClinicalTrials.gov ID
- NCT07071506
- Acronym / sponsor ID
- UAarhus_Chronic migraine
- Keywords
- Headache, Chronic migraine, Balanced placebo design, Treatment effects, Adverse events
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Jul 2025 (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, balanced placebo design, patients with chronic migraine will receive four treatment conditions in a randomized order.
Detailed description
The existing paradigm for testing the effect of treatment 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 studies 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 some of the shortcomings of the RCT by balancing the information given to the patients with the actual treatment administered. In this project, patients suffering from chronic migraine will receive a total of 4 injections over 8 months. Half of them are femanezumab, while the other half are placebo (an inactive injection). The injections (fremanezumab and placebo) look the same, and neither the patient nor the investigator know which injection will be administered. The order will be randomized. The injections are given with different information about what the patients are receiving. To avoid a carry-over effect, the patients will receive one injection every second month. The first month will be without treatment whereupon the patient will receive the first injection. During the first 28 days before and after each administration, patients rate outcome measures in an electronic pain/headache diary at home. In addition, they will also fill out questionnaires assessing their quality of life, psychological parameters and the headache burden.
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) Fremanezumab or 2) placebo, twice.
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Drug: Active drug for chronic migraine treatment.Active drug |
| Placebo group | Placebo comparator | Drug: Placebo Subcutaneous injectionInactive 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 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
- Ability to speak and read Danish
Key exclusion criteria (7 listed)
- 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
- Severe psychiatric, vascular disease, or known liver disease
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 chronic migraine treatment.Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously | Drug | Active group |
| Placebo Subcutaneous injectionInactive placebo (saline) injected subcutaneously in the same volume as the active drug | Drug | Placebo group |
Primary outcome
Mean change in headache intensity
Time frame: Measured every day during the 8 month trial period
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.
Mean change in moderate/severe headache days
Time frame: Measured every day during the 8 month trial period
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.
Adverse events
Time frame: 24 hours, 14 and 28 days 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 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.
8 secondary outcomes
Migraine days
Time frame: Measured every day during the 8 month trial period
Acute treatment utilization
Time frame: Measured every day during the 8 month trial period
Positive and negative affect (PANAS)
Time frame: Pre-treatment and 28 days after each treatment administration
Hospital Anxiety and Depression Scale (HADS)
Time frame: Pre-treatment and 28 days after each treatment administration
Quality of life (SF-12)
Time frame: Pre-treatment and 28 days after each treatment administration
HIT-6
Time frame: Pre-treatment and 28 days after each treatment administration
Intensity of experienced adverse events
Time frame: 24 hours, 14 days and 28 days after each treatment administration
Blinding
Time frame: 28 days 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 19 May 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.
Lene Vase, MSc, PhD, DMSc principal investigator
Dept. of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark
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 chronic migraine treatment. in people with Migraine and Migraine With or 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 7 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 19 May 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?
Mean change in headache intensity (time frame: Measured every day during the 8 month trial period). The study lists 3 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 19 May 2026.