Pharmacologically Triggered Migraine Without Aura and Neuroimaging

Migraine With Aura Clinical Trial

Official title:

MR-Angiografi (MRA) og MR-Spektroskopi (MRS) Hos Raske forsøgspersoner og Patienter Med migræne Uden Aura Provokeret Med Calcitonin Gen-relateret Peptid (CGRP) og Sildenafil

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03143465
• Other study ID #: H-15019063
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: May 2019

Study information

• Verified date: February 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

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)

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura
• Migraine without Aura

Intervention

Drug:
• Calcitonin Gene-Related Peptide

• Sildenafil

• Placebo

Locations

Country	Name	City	State
Denmark	Danish Headache Center, University Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGRP and sildenafil induced headache and MRI changes	CGRP and sildenafil induced headache and MRI changes	0- 12h