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Pharmacologically Triggered Migraine Without Aura and Neuroimaging

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Samaira Younis, Danish Headache Center
Sponsor:
Information provided by (Responsible Party):
Samaira Younis, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT03143465
First received: May 4, 2017
Last updated: NA
Last verified: May 2017
History: No changes posted
  Purpose

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 Intervention
Migraine With Aura Drug: Calcitonin Gene-Related Peptide Drug: Sildenafil Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Masking Description:
Double Blind
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Samaira Younis, Danish Headache Center:

Primary Outcome Measures:
  • CGRP and sildenafil induced MRI-changes [ Time Frame: 0-6h ]
    CGRP and sildenafil induced MRI-changes


Estimated Enrollment: 36
Actual Study Start Date: August 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CGRP Drug: Calcitonin Gene-Related Peptide
Experimental: Sildenafil Drug: Sildenafil
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03143465

Contacts
Contact: Samaira Younis +4538632176 samaira.younis.01@regionh.dk

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

Responsible Party: Samaira Younis, MD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03143465     History of Changes
Other Study ID Numbers: H-15019063
Study First Received: May 4, 2017
Last Updated: May 4, 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
Calcitonin
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2017