Clinical trial NCT04260087: New Daily Persistent Headache Biomarkers Study
Official title: Plasma Calcitonin Gene-Related Peptide and Nerve Growth Factor Levels in New Daily Persistent Headache and Chronic Migraine to Identify Potential Biomarkers and Therapeutics Targets
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: New Daily Persistent Headache
New Daily Persistent Headache (NDPH)
Keywords: Headache
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Migraine Research Foundation
name: Eli Lilly and Company
First posted: 2020-02-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Initial participants were recruited from Montefiore and nearby hospitals. Study is also open to general public.

Brief summary: New daily persistent headache is a debilitating syndrome which is seldom researched, poorly understood, and without effective treatments. Chronic migraine is a more common but similarly disabling disorder. The goal of this study is to evaluate the blood levels of two proteins involved with pain signaling; calcitonin gene-related peptide (CGRP) and nerve growth factor (NGF).

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.


Eligibility criteria: Inclusion Criteria:

* to add

Exclusion Criteria:

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Primary outcomes:
measure: Calcitonin Gene-Related Peptide (CGRP) Levels in Blood
timeFrame: At enrollment
measure: Nerve Growth Factors (NGF) Levels in Blood
timeFrame: At enrollment
Secondary outcomes:
measure: Clinical characteristics of headache or chronic migraine Clinical characteristics clinical characteristics - need to list separately
timeFrame: up to 30 days
measure: Assessment of Light sensitivity
timeFrame: At enrollment
measure: Visual Aura Rating Scale (VARS) for migraine
timeFrame: At enrollment
measure: Allodynia Symptom Checklist (ASC-12) Score
timeFrame: At enrollment
measure: Migraine Disability Assessment Score (MIDAS)
timeFrame: At enrollment
measure: Pain Catastrophizing Scale (PCS)
timeFrame: At enrollment
measure: Pain Self-Efficacy Questionnaire
timeFrame: At enrollment
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: At enrollment
measure: Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: At enrollment
measure: Short Form 36 Health Survey (SF-36)
timeFrame: At enrollment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Headache Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Richard Lipton, MD
role: PRINCIPAL_INVESTIGATOR
References: