New Daily Persistent Headache Biomarkers Study

NCT04260087 | Terminated

• 1 other identifier: 2016-5993
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

New Daily Persistent Headache; New Daily Persistent Headache (NDPH)

Keywords

Headache

Outcome Measures

Primary Outcomes (2)

• Calcitonin Gene-Related Peptide (CGRP) Levels in Blood

  At enrollment

• Nerve Growth Factors (NGF) Levels in Blood

  At enrollment

Secondary Outcomes (10)

• Clinical characteristics of headache or chronic migraine Clinical characteristics clinical characteristics - need to list separately

  up to 30 days

• Assessment of Light sensitivity

  At enrollment

• Visual Aura Rating Scale (VARS) for migraine

  At enrollment

• Allodynia Symptom Checklist (ASC-12) Score

  At enrollment

• Migraine Disability Assessment Score (MIDAS)

  At enrollment

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• to add

You may not qualify if:

• to add

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Migraine Research Foundation: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Montefiore Headache Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Lipton, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: May 1, 2018
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)