Health TrialsbyHealthPanel

Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide

ConditionsMigraine AuraMigraine With Aura
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDanish Headache Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Calcitonin-gene related peptide (CGRP)

    Drug

    The participants will receive a continuous intravenous infusion of 1.5 μg/min of CGRP over 60 minutes.

  • Placebo

    Drug

    The participants will receive a continuous intravenous infusion of 60 mL of placebo (isotonic saline) over 60 minutes.

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: Calcitonin gene-related peptide (CGRP)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 hours

Secondary outcomes

1

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.

Time frame
12 hours
2

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.

Time frame
12 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danish Headache Center

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Source ClinicalTrials.gov
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