Pharmacologically Triggered Migraine Without Aura and Neuroimaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03143465
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : May 8, 2017
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.

We 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.

We 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

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
Actual Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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 MRI-changes [ Time Frame: 0-6h ]
    CGRP and sildenafil induced 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)
  • Unilateral headache (patient group only)
  • Use of safe contraception (women of fertile age only)

Exclusion Criteria:

  • 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)
  • Any other primary headache disorder
  • Daily intake of medication
  • 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 ineligble for participation by the study physicians
  • Contraindications of MRI

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 identifier (NCT number): NCT03143465

Contact: Samaira Younis +4538632176

Danish Headache Center, University Hospital Recruiting
Glostrup, Denmark
Contact: Samaira Younis         
Sponsors and Collaborators
Danish Headache Center

Responsible Party: Samaira Younis, MD, Danish Headache Center Identifier: NCT03143465     History of Changes
Other Study ID Numbers: H-15019063
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sildenafil Citrate
Calcitonin Gene-Related Peptide
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Bone Density Conservation Agents
Physiological Effects of Drugs