The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) in Episodic Migraine Patients
1 other identifier
interventional
21
1 country
1
Brief Summary
Vasoactive intestinal peptide (VIP) is a peptide of 28 amino acid residues that belongs to the glucagon/secretin superfamily of peptides. Along with other neuropeptides, such as calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide (PACAP), it is released from the trigeminal afferents and exerts a strong vasodilating activity on the cranial vasculature. Especially, it shares 70% structure with PACAP and acts on the same receptors. But, unlike it, VIP cannot induce a long-lasting vasodilation and has a modest capability to induce migraine attacks. Whether it may induce migraine-like attacks in migraine patients, as a twenty-minute infusion of PACAP, is unknown.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2020
CompletedFirst Posted
Study publicly available on registry
February 7, 2020
CompletedStudy Start
First participant enrolled
May 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2020
CompletedOctober 20, 2020
October 1, 2020
4 months
February 5, 2020
October 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of migraine-like attacks
Migraine-like attack fulfilling either (i) or (ii): (i) Headache fulfilling criteria C and D for migraine without aura according to the International Classification od Headache Disorders: C. Headache has at least two of the following four characteristics: unilateral location; pulsating quality; moderate or severe pain intensity (moderate pain intensity is considered 5 or 4 on verbal rating scale); aggravation by cough (hospitalization phase) or causing avoidance of routine physical activity (out-hospital phase); D. During headache at least one of the following: nausea and/or vomiting; photophobia and phonophobia; (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).
Before (-10 minutes) and after the drug administration (+12 hours)
Secondary Outcomes (4)
Change in cranial hemodynamic
Before (-10 minutes) and after the drug administration (+3 hours)
Occurrence of headache and change of headache intensity scores
Before (-10 minutes) and after the drug administration (+12 hours)
Change in Mean Arterial Pressure
Before (-10 minutes) and after the drug administration (+3 hours and 20 minutes)
Change in Heart Rate
Before (-10 minutes) and after the drug administration (+3 hours and 20 minutes)
Study Arms (2)
Vasoactive Intestinal Polypeptide (VIP)
ACTIVE COMPARATORIntravenous infusion of 8 pmol/Kg/min of Vasoactive Intestinal Polypeptide (VIP). The infusion is administered at constant speed by an automatic pump, lasting 120 minutes.
Sterile, isotonic, non-active saline (Placebo)
PLACEBO COMPARATORIntravenous infusion of sterile, isotonic, non-active saline 9 mg/ml (placebo). The infusion is administered at constant speed by an automatic pump, lasting 120 minutes.
Interventions
20 episodic migraine patients without aura of both genders are randomized to receive a 2-hour infusion of VIP and/or sterile saline on two days, with at least one week in between.
20 episodic migraine patients without aura of both genders are randomized to receive a 2-hour infusion of VIP and/or sterile saline on two days, with at least one week in between.
Eligibility Criteria
You may qualify if:
- Diagnosis of migraine without aura as according to the International Classification
- Frequency of migraine attacks between one and six attacks within 8 weeks
- Weight: 50-90 kg
- Fertile women should use contraception. Fertile women do not include hysterectomies women or women who are postmenopausal for at least 2 years. Contraception includes either IUD, birth control pills, surgical sterilization of the woman or depot progesterone
You may not qualify if:
- Any other type of headache (including \> 2 days of tension-type headache per month)
- Headache less than 48 hours before the start of the experiment
- Daily intake of any medicine other than oral contraception
- Pregnant or breastfeeding women
- Clinical signs of Hypertension (systolic blood pressure \> 150 mmHg and / or diastolic blood pressure \> 100 mmHg) and/or Hypotension (systolic blood pressure \< 90 mm Hg and / or diastolic blood pressure \< 50 mmHg)
- Cardiovascular disease of all kinds, including cerebrovascular disease
- Anamnestic or clinical signs of mental illness, abuse or smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Danish Headache Center
Glostrup Municipality, Copenhagen, 2600, Denmark
Related Publications (2)
Pellesi L, Al-Karagholi MA, De Icco R, Chaudhry BA, Lopez CL, Snellman J, Hannibal J, Amin FM, Ashina M. Plasma Levels of CGRP During a 2-h Infusion of VIP in Healthy Volunteers and Patients With Migraine: An Exploratory Study. Front Neurol. 2022 Apr 1;13:871176. doi: 10.3389/fneur.2022.871176. eCollection 2022.
PMID: 35432170DERIVEDPellesi L, Al-Karagholi MA, De Icco R, Coskun H, Elbahi FA, Lopez-Lopez C, Snellman J, Hannibal J, Amin FM, Ashina M. Effect of Vasoactive Intestinal Polypeptide on Development of Migraine Headaches: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2118543. doi: 10.1001/jamanetworkopen.2021.18543.
PMID: 34357396DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Messoud Ashina, MD, PhD
Danish Headache Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 5, 2020
First Posted
February 7, 2020
Study Start
May 19, 2020
Primary Completion
September 15, 2020
Study Completion
September 15, 2020
Last Updated
October 20, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share