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Transcriptomic and Biochemical Changes During a Migraine Attack

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ClinicalTrials.gov Identifier: NCT02468622
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Katrine Falkenberg, Danish Headache Center

Tracking Information
First Submitted Date June 4, 2015
First Posted Date June 11, 2015
Last Update Posted Date December 16, 2019
Study Start Date August 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2019)
  • Transcriptomic changes [ Time Frame: 2 year ]
    The investigators will measure transcriptomic changes using Next Generation Sequencing during a migraine attack
  • Changes in CGRP levels during a migraine attack (CGRP1-37, CGRP1-17, CGRP18-37, CGRP1-26, CGRP27-37) [ Time Frame: 2 year ]
    The investigators will use advanced mass spectrometry to measure CGRP levels
  • Changes in PACAP levels during a migraine attack (PACAP-27, PACAP-38 ) [ Time Frame: 2 years ]
    The investigators will use advanced mass spectrometry to measure PACAP levels
  • Changes in VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP [ Time Frame: 2 years ]
    The investigators will use advanced mass spectrometry to measure VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP during a migraine attack
  • Changes in Metabolomics [ Time Frame: 3 years ]
    The investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples
  • Changes in Proteomics [ Time Frame: 3 years ]
    The investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples
Original Primary Outcome Measures
 (submitted: June 10, 2015)
  • Transcriptomic changes [ Time Frame: 2 year ]
    The investigators will measure transcriptomic changes using Next Generation Sequencing during a migraine attack
  • Changes in CGRP levels during a migraine attack (CGRP1-37, CGRP1-17, CGRP18-37, CGRP1-26, CGRP27-37) [ Time Frame: 2 year ]
    The investigators will use advanced mass spectrometry to measure CGRP levels
  • Changes in PACAP levels during a migraine attack (PACAP-27, PACAP-38 ) [ Time Frame: 2 years ]
    The investigators will use advanced mass spectrometry to measure PACAP levels
  • Changes in VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP [ Time Frame: 2 years ]
    The investigators will use advanced mass spectrometry to measure VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP during a migraine attack
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Transcriptomic and Biochemical Changes During a Migraine Attack
Official Title Transcriptomic and Biochemical Changes During Spontaneous Attacks of Migraine With Aura and Migraine Without Aura
Brief Summary Despite the fact that migraine is a common disorder, the pathogenesis is still not fully elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous migraine-attacks will enhance our understanding and may point to new targets for drug development.
Detailed Description

Migraine is a common neurological disorder affecting approx. 16 % of the European population. Despite the fact that migraine is a common disorder, the pathogenesis is still not sufficiently known.

Studying transcriptomic and biochemical changes during spontaneous migraine-attacks will greatly enhance our understanding of migraine mechanisms and may point to new targets for drug development.

Two blood samples (one for RNA analysis and one for biochemical analysis) are taken on minimum 15 patient with migraine with aura and 15 patients with migraine without aura when they experience a spontaneous migraine attack. A second sample is taken 2 hours after treatment with subcutaneous sumatriptan. Another two blood samples are taken when the patient has been migraine free for at least 5 days and had no other headache for at least 24 hours. A fourth set of blood samples are collected after a cold pressor test.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Bloodsamples
Sampling Method Non-Probability Sample
Study Population 15 patients with migraine without aura and 15 paitients with migraine with aura
Condition Migraine
Intervention Other: Blood samples
There is no intervention, but we will take blood samples during a spontaneous migraine attack
Study Groups/Cohorts
  • MO patients
    Patients with migraine without aura. We will take blood samples during spontaneous migraine attacks
    Intervention: Other: Blood samples
  • MA patients
    Patients with migraine with aura. We will take blood samples during spontaneous migraine attacks
    Intervention: Other: Blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 10, 2015)		 30
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Migraine patients who meet IHS criteria for migraine with or without aura of both sexes,
  • 18-70 years,
  • 45-95 kg.

Exclusion Criteria:

  • any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week),
  • serious somatic or psychiatric disease,
  • pregnancy,
  • and intake of daily medication (except oral contraceptives).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02468622
Other Study ID Numbers Transcriptomics
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Katrine Falkenberg, Danish Headache Center
Study Sponsor Danish Headache Center
Collaborators Not Provided
Investigators
Principal Investigator: Emma Katrine Hansen, Doctor Danish Headache Center
PRS Account Danish Headache Center
Verification Date December 2019