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New treatment option for Migraine Aura
Official title Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide
ClinicalTrials.gov ID: NCT07021859
What this study is testing
What is Calcitonin-gene related peptide (CGRP)?
Calcitonin-gene related peptide (CGRP) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for migraine aura.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- Any history of a primary or secondary headache disorder other than migraine without aura, migraine with aura, chronic migraine, and episodic...
- History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the...
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- Female people 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...
See the full eligibility criteria
- 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.
- 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...
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- Female people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glostrup Municipality, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glostrup Municipality, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.