Status:
COMPLETED
Plasma Levels of CGRP and Expression of Specific microRNAs in Blood Cells of Episodic and Chronic Migraine Subjects
Lead Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborating Sponsors:
University of Pavia
Conditions:
Migraine
Eligibility:
All Genders
18+ years
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, t...
Detailed Description
Chronic migraine (CM) is a highly disabling condition that frequently manifests as a negative evolution of episodic migraine (EM) taking place over years. In a recent meta-analysis on the predictors o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2019
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04473976
Start Date
December 15 2017
End Date
June 15 2019
Last Update
July 20 2020
Active Locations (1)
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1
Headache Science Center
Pavia, Italy, 27100