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Study · Randomized controlled trial · n = 21 · 2021

4 results

Effect of Vasoactive Intestinal Polypeptide on Development of Migraine Headaches: A Randomized Clinical Trial.

Pellesi L, Al-Karagholi MA, De Icco R, Coskun H, Elbahi FA, Lopez-Lopez C, Snellman J, Hannibal J, Amin FM, Ashina M

JAMA network open2 Aug 2021Cited by 65 (Europe PMC)

PMID34357396 (opens in a new tab)PMCIDPMC8346940 (opens in a new tab)DOI10.1001/jamanetworkopen.2021.18543 (opens in a new tab)PepBankPUB-34357396
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Summary

ImportanceVasoactive intestinal polypeptide (VIP) and pituitary adenylate cyclase-activating polypeptides (PACAPs) are structurally and functionally related, yet different in their migraine-inducing properties. It remains unclear whether the lack of migraine induction can be attributed to the only transient vasodilatory response after a 20-minute infusion of VIP.ObjectiveTo determine whether a 2-hour infusion of VIP would provoke migraine attacks.Design, setting, and participantsA randomized, double-blind, placebo-controlled, crossover study was conducted between May and September 2020 at the Danish Headache Center in Copenhagen, Denmark. Patients were eligible for inclusion if they were ages 18 to 40 years, weighed between 50 and 90 kg, had a diagnosis of migraine without aura as defined by the International Classification of Headache Disorders, and had a migraine frequency of 1 to 6 attacks per month.InterventionsPatients were randomly allocated to receive a 2-hour infusion of VIP or placebo on 2 different days.Main outcomes and measuresThe primary end point was the difference in incidence of experimentally induced migraine attacks during the observational period (0-12 hours) between VIP and placebo.ResultsTwenty-one patients (17 [81%] women and 4 [19%] men; mean [range] age, 25.9 [19-40] years) were recruited in the study. Fifteen patients (71%; 95% CI, 48%-89%) developed migraine attacks after VIP compared with 1 patient (5%; 95% CI, 0%-24%) who developed a migraine attack after placebo (P < .001). The VIP-induced migraine attacks mimicked patients' spontaneous attacks. The area under the curve (AUC) of headache intensity scores (0-12 hours), as well as the AUC of the superficial temporal artery diameter (0-180 minute) were significantly greater after VIP compared with placebo (AUC0-12h, P = .003; AUC0-180min, P < .001).Conclusions and relevanceA 2-hour infusion of VIP caused migraine attacks, suggesting an important role of VIP in migraine pathophysiology. VIP and its receptors could be potential targets for novel migraine drugs.Trial registrationClinicalTrials.gov Identifier: NCT04260035.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialOther

    In adults with migraine without aura, a 2-hour VIP infusion induced migraine attacks in 71% of patients, compared with 5% after placebo.

    In plain wordsIn adults with migraine, a 2-hour VIP infusion caused migraine attacks in far more people than placebo did.

    Peptide
    Vasoactive intestinal peptide (VIP, aviptadil)
    Outcome
    IncreaseIncidence of migraine attacks 0-12 hours after infusion
    Study

    n = 21

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Pain · Nervous system and cognition
    Studied dose
    Dose not stated · 2 hoursAs given in this study (human).

    Measurements

    Patients with migraine attacks
    71%
    VIP
    Patients with migraine attacks
    5%
    placebo

    Source sentences

    Summary
    Fifteen patients (71%; 95% CI, 48%-89%) developed migraine attacks after VIP compared with 1 patient (5%; 95% CI, 0%-24%) who developed a migraine attack after placebo (P < .001).
    3 context sentences
    Summary · context
    The primary end point was the difference in incidence of experimentally induced migraine attacks during the observational period (0-12 hours) between VIP and placebo.
    Summary · context
    A randomized, double-blind, placebo-controlled, crossover study was conducted between May and September 2020 at the Danish Headache Center in Copenhagen, Denmark.
    Summary · context
    Patients were eligible for inclusion if they were ages 18 to 40 years, weighed between 50 and 90 kg, had a diagnosis of migraine without aura as defined by the International Classification of Headache Disorders, and had a migraine frequency of 1 to 6 attacks per month.
  2. 02HumanRandomized controlled trialOther

    In adults with migraine without aura, headache intensity over 0-12 hours was significantly greater after a 2-hour VIP infusion than after placebo.

    In plain wordsIn adults with migraine, headache was more intense after a 2-hour VIP infusion than after placebo.

    Peptide
    Vasoactive intestinal peptide (VIP, aviptadil)
    Outcome
    IncreaseHeadache intensity AUC 0-12 hours
    Study

    n = 21

    Comparator
    Placebo
    Outcome group
    Pain · Nervous system and cognition
    Studied dose
    Dose not stated · 2 hoursAs given in this study (human).

    Source sentences

    Summary
    The area under the curve (AUC) of headache intensity scores (0-12 hours), as well as the AUC of the superficial temporal artery diameter (0-180 minute) were significantly greater after VIP compared with placebo (AUC0-12h, P = .003; AUC0-180min, P < .001).
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, crossover study was conducted between May and September 2020 at the Danish Headache Center in Copenhagen, Denmark.
    Summary · context
    Patients were eligible for inclusion if they were ages 18 to 40 years, weighed between 50 and 90 kg, had a diagnosis of migraine without aura as defined by the International Classification of Headache Disorders, and had a migraine frequency of 1 to 6 attacks per month.
  3. 03HumanRandomized controlled trialMechanism

    In adults with migraine without aura, the superficial temporal artery diameter was significantly greater after a 2-hour VIP infusion than after placebo.

    In plain wordsIn adults with migraine, a scalp artery was wider after a 2-hour VIP infusion than after placebo.

    Peptide
    Vasoactive intestinal peptide (VIP, aviptadil)
    Outcome
    IncreaseSuperficial temporal artery diameter AUC 0-180 minutes
    Study

    n = 21

    Comparator
    Placebo
    Outcome group
    Receptor activity and mechanism · Cardiovascular
    Studied dose
    Dose not stated · 2 hoursAs given in this study (human).

    Source sentences

    Summary
    The area under the curve (AUC) of headache intensity scores (0-12 hours), as well as the AUC of the superficial temporal artery diameter (0-180 minute) were significantly greater after VIP compared with placebo (AUC0-12h, P = .003; AUC0-180min, P < .001).
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, crossover study was conducted between May and September 2020 at the Danish Headache Center in Copenhagen, Denmark.
    Summary · context
    Patients were eligible for inclusion if they were ages 18 to 40 years, weighed between 50 and 90 kg, had a diagnosis of migraine without aura as defined by the International Classification of Headache Disorders, and had a migraine frequency of 1 to 6 attacks per month.
  4. 04HumanRandomized controlled trialOther

    In adults with migraine without aura, the migraine attacks induced by VIP mimicked the patients' spontaneous attacks.

    In plain wordsIn adults with migraine, the attacks caused by VIP looked like the patients' own migraine attacks.

    Peptide
    Vasoactive intestinal peptide (VIP, aviptadil)
    Outcome
    Not applicableResemblance of VIP-induced attacks to spontaneous attacks
    Study

    n = 21

    Comparator
    Patients' spontaneous attacks
    Outcome group
    Pain · Nervous system and cognition
    Studied dose
    Dose not stated · 2 hoursAs given in this study (human).

    Source sentences

    Summary
    The VIP-induced migraine attacks mimicked patients' spontaneous attacks.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, crossover study was conducted between May and September 2020 at the Danish Headache Center in Copenhagen, Denmark.
    Summary · context
    Patients were eligible for inclusion if they were ages 18 to 40 years, weighed between 50 and 90 kg, had a diagnosis of migraine without aura as defined by the International Classification of Headache Disorders, and had a migraine frequency of 1 to 6 attacks per month.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedNot applicableNCT04260035

The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) in Episodic Migraine Patients

Danish Headache Centern = 2119 May 2020 to 15 Sept 2020

Migraine · Pain · Neurologic Manifestations · Signs and Symptoms · Brain Diseases · Central Nervous System Diseases

Trial pageClinicalTrials.govUpdated 20 Oct 2020

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    9 Oct 2026, 19:08 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 12:40 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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