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Pharmacologically Triggered Migraine Without Aura and Neuroimaging

Primary Purpose

Migraine With Aura

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Calcitonin Gene-Related Peptide
Sildenafil
Placebo
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Migraine With Aura

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Danish Headache Center, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CGRP

Sildenafil

Placebo

Arm Description

Outcomes

Primary Outcome Measures

CGRP and sildenafil induced headache and MRI changes
CGRP and sildenafil induced headache and MRI changes

Secondary Outcome Measures

Full Information

First Posted
May 4, 2017
Last Updated
February 11, 2019
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT03143465
Brief Title
Pharmacologically Triggered Migraine Without Aura and Neuroimaging
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CGRP
Arm Type
Experimental
Arm Title
Sildenafil
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Calcitonin Gene-Related Peptide
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
CGRP and sildenafil induced headache and MRI changes
Description
CGRP and sildenafil induced headache and MRI changes
Time Frame
0- 12h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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) 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)
Facility Information:
Facility Name
Danish Headache Center, University Hospital
City
Glostrup
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31684759
Citation
Younis S, Christensen CE, Toft NM, Soborg T, Amin FM, Hougaard A, Ashina M. Investigation of distinct molecular pathways in migraine induction using calcitonin gene-related peptide and sildenafil. Cephalalgia. 2019 Dec;39(14):1776-1788. doi: 10.1177/0333102419882474. Epub 2019 Nov 4.
Results Reference
derived
PubMed Identifier
31060491
Citation
Christensen CE, Younis S, Lindberg U, Boer VO, de Koning P, Petersen ET, Paulson OB, Larsson HBW, Amin FM, Ashina M. Ultra-high field MR angiography in human migraine models: a 3.0 T/7.0 T comparison study. J Headache Pain. 2019 May 6;20(1):48. doi: 10.1186/s10194-019-0996-x. Erratum In: J Headache Pain. 2019 May 28;20(1):62.
Results Reference
derived

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Pharmacologically Triggered Migraine Without Aura and Neuroimaging

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