Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04473976
Previous Study | Return to List | Next Study

Plasma Levels of CGRP and Expression of Specific microRNAs in Blood Cells of Episodic and Chronic Migraine Subjects (CGRP-RNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04473976
Recruitment Status : Completed
First Posted : July 16, 2020
Last Update Posted : July 20, 2020
Sponsor:
Collaborator:
University of Pavia
Information provided by (Responsible Party):
IRCCS National Neurological Institute "C. Mondino" Foundation

Brief Summary:

Migraine can manifest with an episodic or chronic pattern in a continuum of disease severity. Multiple factors are associated to the transformation of the pattern form episodic to chronic. Of these, the most consistently reported is the overuse of medications (MO) for the acute treatment of attacks. Knowledge of the mechanisms through which MO facilitates the transformation of episodic migraine (EM) into chronic migraine (CM) is very limited. In order insights into these mechanisms, the present study was aimed at identifying possible peripheral biomarkers associated to the 2 forms of migraine and to the presence of MO.

The investigators evaluated CGRP plasma levels and the expression of miR-34a-5p and miR-382-5p in peripheral blood mononuclear cells of subjects with episodic migraine (EM, n=27) and CM-MO (n=28). CM-MO group was also tested 2 months after an in-hospital detoxification protocol.


Condition or disease
Migraine

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Plasma Levels of CGRP and Expression of Specific microRNAs in Blood Cells of Episodic and Chronic Migraine Subjects: Toward the Identification of a Panel of Peripheral Biomarkers of Migraine?
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine




Primary Outcome Measures :
  1. Plasma levels of CGRP [ Time Frame: Day 0 at the enrolment ]
    In order to identify individual or a panel of potential biomarkers of migraine subtypes

  2. Expression of miRNAs in PBMCs [ Time Frame: Day 0 at the enrolment ]
    In order to identify individual or a panel of potential biomarkers of migraine subtypes


Secondary Outcome Measures :
  1. Changes in CGRP levels [ Time Frame: Day1 - Two months after Day 0 ]
    In the subjects with CM-MO after detoxification in order to gather more insights into the mechanisms that are involved in the improvement of migraine pattern following the withdrawal of the overused medications.

  2. Changes in miRNAs levels [ Time Frame: Day 1 - Two months after Day 0 ]
    In the subjects with CM-MO after detoxification in order to gather more insights into the mechanisms that are involved in the improvement of migraine pattern following the withdrawal of the overused medications.


Biospecimen Retention:   Samples Without DNA

Blood samples from the cubital vein of each patient was put into a 5 ml lavender tube. Plasma samples were prepared by centrifugation and then stored at -80°C. Plasma CGRP levels were measured using a commercial enzyme-linked immuno-sorbent assay kit.

The miRNAs expression was evaluated by real-time reverse transcription (RT) Polymerase Chain Reaction (PCR) in peripheral blood mononuclear cell (PBMCs). PBMCs were isolated immediately after blood collection. Blood samples were collected within ethylenediamine tetra-acetic acid (EDTA) containing tube and diluted in 1:1 ratio with Phosphate Buffer Saline (PBS). Then, diluted blood samples were slowly loaded into Ficoll separating solution (15 ml) (Sigma) and centrifuged at 800 g for 30 min at room temperature. PBMCs accumulated as the middle white monolayer, were washed twice in sterile PBS at 300 g for 15 min. After washing, PBMCs pellet was resuspended in trizol and stored at -80 °C until use.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Twenty-seven subjects with EM and 28 subjects with CM-MO were consecutively enrolled among patients attending the outpatient clinics of the Headache Science Centre of the IRCCS Mondino Foundation of Pavia (Italy).
Criteria

Inclusion Criteria for EM subjects:

  • diagnosis of migraine without aura according to The International Classification Headache Disorders 3rd edition (ICHD-3) criteria;
  • documented history of EM for at least 10 years before enrollment;
  • negative life-time history of CM.

Exclusion Criteria:

  • headache or headache with migraine features and mild intensity (less than 4 on 0 to 10 visual analogue scale) in the 24 hours before blood sampling;
  • intake of acute anti-migraine medications in the 24 hours before blood sampling.

Inclusion criteria for CM-MO patients:

  • diagnosis of CM and MO according to ICHD-3 criteria;
  • documented pattern of stable CM in the 5 years prior to enrollment, without any remission period. This latter point was verified with a high degree of confidence combining the information obtained from the patients' history with their medical records, including their headache diaries.

Exclusion Criteria:

  • headache or headache with migraine features and mild intensity (less than 4 on 0 to 10 visual analogue scale) in the 24 hours before blood sampling;
  • intake of acute anti-migraine medications in the 24 hours before blood sampling.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473976


Locations
Layout table for location information
Italy
Headache Science Center
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
University of Pavia
Investigators
Layout table for investigator information
Principal Investigator: Cristina Tassorelli, Prof IRCCS Mondino Foundation, Pavia
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: IRCCS National Neurological Institute "C. Mondino" Foundation
ClinicalTrials.gov Identifier: NCT04473976    
Other Study ID Numbers: CGRP-microRNA2020
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS National Neurological Institute "C. Mondino" Foundation:
Migraine
CGRP
MicroRNA
Overuse of medications
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases