New Daily Persistent Headache Biomarkers Study

Terminated

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

• Registration Number: NCT04260087
• Lead Sponsor: Albert Einstein College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-07
• Primary Completion: 2021-11-18
• Study Completion: 2021-11-18
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• to add

Read More

Exclusion Criteria

• to add

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Calcitonin Gene-Related Peptide (CGRP) Levels in Blood	At enrollment
Nerve Growth Factors (NGF) Levels in Blood	At enrollment

Secondary Outcome Measures

Name	Time	Method
Clinical characteristics of headache or chronic migraine Clinical characteristics clinical characteristics - need to list separately	up to 30 days	Assessed through completion of self reported symptoms on 30 day calendar and review of medical records
Assessment of Light sensitivity	At enrollment	The Photosensitivity Assessment Questionnaire that measures the extent to which a person is light sensitive. The questionnaire contains 16 "yes" or "no" questions.
Visual Aura Rating Scale (VARS) for migraine	At enrollment	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
Allodynia Symptom Checklist (ASC-12) Score	At enrollment	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.
Migraine Disability Assessment Score (MIDAS)	At enrollment	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.
Pain Catastrophizing Scale (PCS)	At enrollment	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
Pain Self-Efficacy Questionnaire	At enrollment	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.
Patient Health Questionnaire-9 (PHQ-9)	At enrollment	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
Generalized Anxiety Disorder 7-Item Scale (GAD-7)	At enrollment	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.
Short Form 36 Health Survey (SF-36)	At enrollment	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.

Trial Locations

Locations (1)

Montefiore Headache Center; 🇺🇸 Bronx, New York, United States