Migraine AuraNCT07021859
Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide
A study testing Calcitonin-gene related peptide (CGRP) in people with Migraine Aura and Migraine With Aura, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Calcitonin gene-related peptide (CGRP) is a key neuropeptide in migraine pathophysiology and treatment. This study investigates whether CGRP administration can trigger aura in individuals with a diagnosis of migraine with aura. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Aura, Migraine With Aura
- What is being tested?
- Calcitonin-gene related peptide (CGRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Jun 2025to 30 Dec 2026
- 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
- Age 18 to 65 years of age upon entry into screening
- History of migraine with aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria
- ≥ 1 monthly day with aura that meets criteria as aura on average across the three months before screening
- Provision of informed consent prior to initiation of any study-specific activities/procedures.
Who cannot join
- Any history of a primary or secondary headache disorder other than migraine without aura, migraine with aura, chronic migraine, and episodic tension-type headache
- History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- Female subjects of childbearing potential with a positive pregnancy test during any study visit
- Cardiovascular disease of any kind, including cerebrovascular diseases
- Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
Show all 11Show fewer
- Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
- Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
- Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
- Headache of any intensity within 48 hours of infusion start
- Aura within 48 hours of infusion start
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet Glostrup
Glostrup Municipality, 2600
Haidar Al-Khazali, MD, +4541598494, haidardk@hotmail.com
Hakan Ashina, MD, PhD, +4528102495, haakan.ashina@regionh.dk
About this study
Official title: Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide: A Randomized Clinical Trial
Calcitonin gene-related peptide (CGRP) is a key neuropeptide in migraine pathophysiology and treatment. This study investigates whether CGRP administration can trigger aura in individuals with a diagnosis of migraine with aura.
Read the detailed description
Recent open-label findings show that calcitonin gene-related peptide (CGRP), a key player in migraine, can trigger aura attacks-despite its limited ability to cross the blood-brain barrier. This suggests CGRP might induce migraine aura via trigeminovascular activation, the same pathway involved in migraine headache. If confirmed, this could reshape treatment strategies for patients diagnosed with migraine with aura. To validate this effect and rule out nocebo influence, a randomized, double-blind, placebo-controlled trial is essential. Its outcomes could inform future therapies targeting the migraine-aura connection.
- Conditions
- Migraine Aura, Migraine With Aura
- Being tested
- Calcitonin-gene related peptide (CGRP), Placebo
- Keywords
- Migraine, Aura, Calcitonin gene-related peptide
- Medical subject headings
- Migraine with Aura, Migraine Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitonin-gene related peptide (CGRP)Drug
The participants will receive a continuous intravenous infusion of 1.5 μg/min of CGRP over 60 minutes.
PlaceboDrug
The participants will receive a continuous intravenous infusion of 60 mL of placebo (isotonic saline) over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Calcitonin gene-related peptide (CGRP) | Experimental | CGRP will be administered by intravenous infusion. Receives: Drug: Calcitonin-gene related peptide (CGRP) |
| Placebo | Placebo comparator | Placebo (isotonic saline) will be administered by intravenous infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of migraine attacks with aura
Difference in incidence of migraine attack with aura between CGRP and placebo during the 12-hour observational period after infusion start.
Measured: 12 hours
Secondary outcomes (2)
Incidence of migraine attacks without aura
Difference in incidence of migraine headache between CGRP and placebo during the 12-hour observational period after infusion start.
Measured: 12 hours
Headache intensity scores
Difference in area under the curve (AUC) for headache intensity scores between CGRP and placebo during the 12-hour observational period after infusion start.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start27 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine 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
- This single-center trial applies a randomized, double-blind, placebo-controlled, two-way crossover design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidar Al-Khazali, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021859
- Sponsor's protocol ID
- H-23042433
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data not published within this article will be made available on reasonable request from any qualified investigator.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07021859
- Acronym / sponsor ID
- H-23042433
- Conditions
- Migraine Aura, Migraine With Aura
- Keywords
- Migraine, Aura, Calcitonin gene-related peptide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Jun 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.
Calcitonin gene-related peptide (CGRP) is a key neuropeptide in migraine pathophysiology and treatment. This study investigates whether CGRP administration can trigger aura in individuals with a diagnosis of migraine with aura.
Detailed description
Recent open-label findings show that calcitonin gene-related peptide (CGRP), a key player in migraine, can trigger aura attacks-despite its limited ability to cross the blood-brain barrier. This suggests CGRP might induce migraine aura via trigeminovascular activation, the same pathway involved in migraine headache. If confirmed, this could reshape treatment strategies for patients diagnosed with migraine with aura. To validate this effect and rule out nocebo influence, a randomized, double-blind, placebo-controlled trial is essential. Its outcomes could inform future therapies targeting the migraine-aura connection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This single-center trial applies a randomized, double-blind, placebo-controlled, two-way crossover design.
| Arm | Type | Receives |
|---|---|---|
| Calcitonin gene-related peptide (CGRP) | Experimental | Drug: Calcitonin-gene related peptide (CGRP)CGRP will be administered by intravenous infusion. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (isotonic saline) will be administered by intravenous infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 years of age upon entry into screening
- History of migraine with aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria
- ≥ 1 monthly day with aura that meets criteria as aura on average across the three months before screening
- Provision of informed consent prior to initiation of any study-specific activities/procedures.
Key exclusion criteria (11 listed)
- Any history of a primary or secondary headache disorder other than migraine without aura, migraine with aura, chronic migraine, and episodic tension-type headache
- History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- Female subjects of childbearing potential with a positive pregnancy test during any study visit
- Cardiovascular disease of any kind, including cerebrovascular diseases
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 |
|---|---|---|
| Calcitonin-gene related peptide (CGRP)The participants will receive a continuous intravenous infusion of 1.5 μg/min of CGRP over 60 minutes. | Drug | Calcitonin gene-related peptide (CGRP) |
| PlaceboThe participants will receive a continuous intravenous infusion of 60 mL of placebo (isotonic saline) over 60 minutes. | Drug | Placebo |
Primary outcome
Incidence of migraine attacks with aura
Time frame: 12 hours
Difference in incidence of migraine attack with aura between CGRP and placebo during the 12-hour observational period after infusion start.
2 secondary outcomes
Incidence of migraine attacks without aura
Time frame: 12 hours
Headache intensity scores
Time frame: 12 hours
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 6 Aug 2025.
- Individual participant dataSharing planned: Yes. Anonymized data not published within this article will be made available on reasonable request from any qualified investigator.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcitonin-gene related peptide (CGRP) in people with Migraine Aura and Migraine With Aura, run by Danish Headache Center at 1 site 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 4 inclusion and 11 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Haidar Al-Khazali, MD (+4541598494, haidardk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of migraine attacks with aura (time frame: 12 hours). 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 6 Aug 2025.