Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
8 participants
OBSERVATIONAL
2018-05-01
2021-11-18
Brief Summary
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CGRP levels are known to be elevated in chronic migraine, and recent phase 2 clinical trials suggest that treatments targeting CGRP are safe and effective for treatments for migraine. If CGRP levels are elevated in the blood of people with new daily persistent headache, future studies will be designed to evaluate whether treatments that target CGRP are effective in treating new daily persistent headache. If NGF levels are elevated in the blood of patients with new daily persistent headache and/or chronic migraine, future studies will be designed to evaluate whether treatments that target NGF antibodies (targeted treatments against NGF) are effective in treating NDPH and/or chronic migraine.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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New Daily Persistent Headache
This cohort will consist of participants diagnosed with New Daily Persistent Headache (NDPH). New daily persistent headache (NDPH) is a primary headache syndrome which can mimic chronic migraine and chronic tension-type headache. The headache is daily and unremitting from very soon after onset (within 3 days at most), usually in a person who does not have a history of a primary headache disorder.
Protein levels of calcitonin gene-related peptide (CGRP) and nerve growth factor (NGF) will be measured in this cohort.
No interventions assigned to this group
Chronic Migraine
This cohort will consist of participants diagnosed with chronic migraine. Chronic migraine is defined as headache occurring on 15 or more days per month for more than three months, which, on at least 8 days per month, has the features of migraine headache. Chronic migraine occurs in approximately 1% of the population. Studies estimate that about 2.5% of people with episodic migraine will transition to chronic migraine each year.
Protein levels of calcitonin gene-related peptide (CGRP) and nerve growth factor (NGF) will be measured in this cohort.
No interventions assigned to this group
Healthy Volunteers
This cohort will consist of healthy volunteers who have not been diagnosed with either NDPH or chronic migraine.
Protein levels of calcitonin gene-related peptide (CGRP) and nerve growth factor (NGF) will be measured in this cohort.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
Yes
Sponsors
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Migraine Research Foundation
OTHER
Eli Lilly and Company
INDUSTRY
Albert Einstein College of Medicine
OTHER
Responsible Party
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Principal Investigators
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Richard Lipton, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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Montefiore Headache Center
The Bronx, New York, United States
Countries
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Other Identifiers
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2016-5993
Identifier Type: -
Identifier Source: org_study_id
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