New Daily Persistent Headache Biomarkers Study (NDPH)

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

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.

Study Overview

• Status: Terminated
• Conditions: New Daily Persistent Headache; New Daily Persistent Headache (NDPH)

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Initial participants were recruited from Montefiore and nearby hospitals. Study is also open to general public.

Description

Inclusion Criteria:

• to add

Exclusion Criteria:

• to add

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Calcitonin Gene-Related Peptide (CGRP) Levels in Blood	At enrollment
Nerve Growth Factors (NGF) Levels in Blood	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical characteristics of headache or chronic migraine Clinical characteristics clinical characteristics - need to list separately	Assessed through completion of self reported symptoms on 30 day calendar and review of medical records	up to 30 days
Assessment of Light sensitivity	The Photosensitivity Assessment Questionnaire that measures the extent to which a person is light sensitive. The questionnaire contains 16 "yes" or "no" questions.	At enrollment
Visual Aura Rating Scale (VARS) for migraine	The VARS contains 5 "yes" or "no/not applicable" questions in which respondents are asked to indicate any visual disturbances when headache/migraine symptoms occur	At enrollment
Allodynia Symptom Checklist (ASC-12) Score	The ASC 12 is a 12 item checklist that evaluates allodynia symptoms associated with headache attacks. Each situations are scored as "does not apply to me", "never", "rarely", "less than half", "half or more often". Total score ranged between 0-24 points.	At enrollment
Migraine Disability Assessment Score (MIDAS)	The MIDAS contains 5 questions that identifies migraine disability in all areas of activity during the last 3 months. Total score ranges from 0-90 and is used to categorize patients in disability grades I to IV.	At enrollment
Pain Catastrophizing Scale (PCS)	PCS consists of 13 items rated on a 5-point Likert scales from 0 ([Not at all/Not Applicable) to 4 (All the time) points. The total score for the PCS is 52, with points more than 24 indicating a high level of catastrophizing	At enrollment
Pain Self-Efficacy Questionnaire	This consists of 10 items rated on a 10-point Likert scales from 0 ( not at all confident) to 6(completely confident). It will be used to assess the participants' confidence in their ability to perform specific tasks or their confidence in performing more generalized constructs such as coping with chronic non-malignant pain.	At enrollment
Patient Health Questionnaire-9 (PHQ-9)	PHQ-9 is a self-administered depression scale, which scores each of the 9 DSM-IV (Diagnostic and Statistical Manual-IV) criteria as "0" (not at all) to "3" (nearly every day).PHQ-9 scores are summed, and scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively	At enrollment
Generalized Anxiety Disorder 7-Item Scale (GAD-7)	The GAD-7 is a validated instrument for the diagnosis and treatment response of anxiety disorder. It scores each of the 7 criteria 0" (not at all) to "3" (nearly every day)with a total score ranging from 0-21 . Scores of 5-9, 10-14, and 15-21 represent mild, moderate and severe generalized anxiety disorder, respectively.	At enrollment
Short Form 36 Health Survey (SF-36)	The SF-36 will used to understand the health related quality-of -life of the participants over the past four weeks. The eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions will be searched. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.	At enrollment

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: Eli Lilly and Company; Migraine Research Foundation
• Investigators: Principal Investigator: Richard Lipton, MD, Albert Einstein College Of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): November 18, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Headache
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: 2016-5993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No