Pharmacologically Triggered Migraine Without Aura and Neuroimaging

Not Applicable

• Conditions: Migraine With Aura
• Interventions: Drug: Placebo; Drug: Sildenafil; Drug: Calcitonin Gene-Related Peptide

• Registration Number: NCT03143465
• Lead Sponsor: Danish Headache Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Primary Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-15
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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
• No use of safe contraception (women of fertile age only)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Sildenafil	Sildenafil	-
CGRP	Calcitonin Gene-Related Peptide	-

Primary Outcome Measures

Name	Time	Method
CGRP and sildenafil induced headache and MRI changes	0- 12h	CGRP and sildenafil induced headache and MRI changes

Trial Locations

Locations (1)

Danish Headache Center, University Hospital; 🇩🇰 Glostrup, Denmark