Pharmacologically Triggered Migraine Without Aura and Neuroimaging

February 11, 2019 updated by: Samaira Younis, Danish Headache Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark
        • Danish Headache Center, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Sildenafil
Drug: Sildenafil
Experimental: CGRP
Drug: Calcitonin Gene-Related Peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGRP and sildenafil induced headache and MRI changes
Time Frame: 0- 12h
CGRP and sildenafil induced headache and MRI changes
0- 12h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15019063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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