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Pharmacologically Triggered Migraine Without Aura and Neuroimaging

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ClinicalTrials.gov Identifier: NCT03143465
Recruitment Status : Unknown
Verified February 2019 by Samaira Younis, Danish Headache Center.
Recruitment status was:  Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : February 15, 2019
Information provided by (Responsible Party):
Samaira Younis, 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.

Condition or disease Intervention/treatment Phase
Migraine With Aura Drug: Calcitonin Gene-Related Peptide Drug: Sildenafil Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Basic Science
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: CGRP Drug: Calcitonin Gene-Related Peptide
Experimental: Sildenafil Drug: Sildenafil
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. CGRP and sildenafil induced headache and MRI changes [ Time Frame: 0- 12h ]
    CGRP and sildenafil induced headache and MRI changes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143465

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Danish Headache Center, University Hospital
Glostrup, Denmark
Sponsors and Collaborators
Danish Headache Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samaira Younis, MD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03143465    
Other Study ID Numbers: H-15019063
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Salmon calcitonin
Sildenafil Citrate
Calcitonin Gene-Related Peptide
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents