Pharmacologically Triggered Migraine Without Aura and Neuroimaging

NCT03143465 | Unknown

• 1 other identifier: H-15019063
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Migraine is a highly disabling disorder affecting 14% of the general population Worldwide and ranked as the 6th most debilitating disease worldwide by the WHO. One of the most fundamental questions of migraine, which remains to be elucidated, is the mechanism behind the generation of migraine attacks. The investigators will use calcitonin gene-related peptide (CGRP) and sildenafil as pharmacological triggers of migraine, combined with advanced neuroimaging techniques, to investigate the attack initiating pathophysiology. Both substances have previously been administered to healthy participants and migraine without aura patients, inducing headache and migraine-like-attacks. The investigators hope to contribute with novelty to the current understanding of the migraine pathophysiology and development of more efficient treatment of migraine.

Conditions

Migraine With Aura

Outcome Measures

Primary Outcomes (1)

• CGRP and sildenafil induced headache and MRI changes

  CGRP and sildenafil induced headache and MRI changes

  0- 12h

Study Arms (3)

CGRP

EXPERIMENTAL

Drug: Calcitonin Gene-Related Peptide

Sildenafil

EXPERIMENTAL

Drug: Sildenafil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Calcitonin Gene-Related Peptide DRUG

CGRP

Sildenafil DRUG

Sildenafil

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 50 years
• Weight: 50-100 kg
• Diagnosis of migraine without aura (patient group only)
• Attacks of migraine without aura at least once every second month (patient group only)

You may not qualify if:

• Inconsistent laterality of headache
• History or family history of migraine (healthy subject group only)
• Tension-type headache more than one day per month on average (healthy subject group only)
• Tension-type headache to such a degree that the episodic migraine diagnosis is no longer fulfilled
• Any other primary headache disorder
• Daily intake of medication (apart from oral contraceptives)
• Intake of any medication less than 4 half-lives before study start
• Daily smoking
• Pregnant or breastfeeding women
• Headache 48 h prior to study day
• Hypertension on the study day (systolic BP\>150 mmHg or diastolic BP\> 100 mmHg)
• Hypotension on the study day (systolic BP\<90 mmHg or diastolic BP\<50 mmHg)
• History of any cardiovascular disease including cerebrovascular disease
• Any disorder, that is deemed ineligible for participation by the study physicians
• Contraindications of MRI

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center, University Hospital

Glostrup Municipality, Denmark

Location

Related Publications (2)

• Younis S, Christensen CE, Toft NM, Soborg T, Amin FM, Hougaard A, Ashina M. Investigation of distinct molecular pathways in migraine induction using calcitonin gene-related peptide and sildenafil. Cephalalgia. 2019 Dec;39(14):1776-1788. doi: 10.1177/0333102419882474. Epub 2019 Nov 4.

  PMID: 31684759 DERIVED

• Christensen CE, Younis S, Lindberg U, Boer VO, de Koning P, Petersen ET, Paulson OB, Larsson HBW, Amin FM, Ashina M. Ultra-high field MR angiography in human migraine models: a 3.0 T/7.0 T comparison study. J Headache Pain. 2019 May 6;20(1):48. doi: 10.1186/s10194-019-0996-x.

  PMID: 31060491 DERIVED

MeSH Terms

Conditions

Migraine with Aura

Interventions

Calcitonin Gene-Related Peptide; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: August 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)