New Daily Persistent Headache Biomarkers Study

New Daily Persistent Headache Clinical Trial

— NDPH  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04260087
• Other study ID #: 2016-5993
• Status: Terminated
• Start date: May 1, 2018
• Est. completion date: November 18, 2021

Study information

• Verified date: February 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• to add

Exclusion Criteria:

• to add

Related Conditions & MeSH terms

• Headache
• New Daily Persistent Headache
• New Daily Persistent Headache (NDPH)

Locations

Country	Name	City	State
United States	Montefiore Headache Center	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Eli Lilly and Company, Migraine Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcitonin Gene-Related Peptide (CGRP) Levels in Blood		At enrollment
Primary	Nerve Growth Factors (NGF) Levels in Blood		At enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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