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Pharmacologically Triggered Migraine Without Aura and Neuroimaging

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

Tracking Information
First Submitted Date  ICMJE May 4, 2017
First Posted Date  ICMJE May 8, 2017
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2019)
CGRP and sildenafil induced headache and MRI changes [ Time Frame: 0- 12h ]
CGRP and sildenafil induced headache and MRI changes
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
CGRP and sildenafil induced MRI-changes [ Time Frame: 0-6h ]
CGRP and sildenafil induced MRI-changes
Change History Complete list of historical versions of study NCT03143465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacologically Triggered Migraine Without Aura and Neuroimaging
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
Primary Purpose: Basic Science
Condition  ICMJE Migraine With Aura
Intervention  ICMJE
  • Drug: Calcitonin Gene-Related Peptide
  • Drug: Sildenafil
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: CGRP
    Intervention: Drug: Calcitonin Gene-Related Peptide
  • Experimental: Sildenafil
    Intervention: Drug: Sildenafil
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2017)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03143465
Other Study ID Numbers  ICMJE H-15019063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samaira Younis, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Danish Headache Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP