New Daily Persistent HeadacheNDPHNCT04260087
New Daily Persistent Headache Biomarkers Study
An observational study of New Daily Persistent Headache and New Daily Persistent Headache (NDPH), run by Albert Einstein College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- New Daily Persistent Headache, New Daily Persistent Headache (NDPH)
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 18 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Initial participants were recruited from Montefiore and nearby hospitals. Study is also open to general public.
Who may be able to join
- to add
Who cannot join
- to add
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Headache Center
The Bronx, New York, 10461
About this 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
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.
- Keywords
- Headache
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Calcitonin Gene-Related Peptide (CGRP) Levels in Blood
Measured: At enrollment
Nerve Growth Factors (NGF) Levels in Blood
Measured: At enrollment
Secondary outcomes (10)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 May 2018
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Why it stopped: Study Terminated due to COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Daily Persistent HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Migraine Research Foundation, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Richard Lipton, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260087
- Sponsor's protocol ID
- 2016-5993
- Acronym
- NDPH
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2020
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04260087
- Acronym / sponsor ID
- NDPH / 2016-5993
- Keywords
- Headache
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study Terminated due to COVID-19.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Migraine Research Foundation, Eli Lilly and Company
- Study start
- 1 May 2018 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Initial participants were recruited from Montefiore and nearby hospitals. Study is also open to general public.
Key inclusion criteria (1 listed)
- to add
Key exclusion criteria (1 listed)
- to add
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calcitonin Gene-Related Peptide (CGRP) Levels in Blood
Time frame: At enrollment
Nerve Growth Factors (NGF) Levels in Blood
Time frame: At enrollment
10 secondary outcomes
Clinical characteristics of headache or chronic migraine Clinical characteristics clinical characteristics - need to list separately
Time frame: up to 30 days
Assessment of Light sensitivity
Time frame: At enrollment
Visual Aura Rating Scale (VARS) for migraine
Time frame: At enrollment
Allodynia Symptom Checklist (ASC-12) Score
Time frame: At enrollment
Migraine Disability Assessment Score (MIDAS)
Time frame: At enrollment
Pain Catastrophizing Scale (PCS)
Time frame: At enrollment
Pain Self-Efficacy Questionnaire
Time frame: At enrollment
Patient Health Questionnaire-9 (PHQ-9)
Time frame: At enrollment
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: At enrollment
Short Form 36 Health Survey (SF-36)
Time frame: At enrollment
Results and safety
The study was stopped early (reason given: Study Terminated due to COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for New Daily Persistent Headache
RecruitingObservational study
China HeadAche DIsorders RegiStry
Headache Disorders, Primary, Migraine
RecruitingObservational study
Analysis of Headache Chronification With Imaging, Deep Phenotyping, and Proteomics
Chronic Daily Headache, Chronic Migraine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Lipton, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of New Daily Persistent Headache and New Daily Persistent Headache (NDPH), run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study Terminated due to COVID-19.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcitonin Gene-Related Peptide (CGRP) Levels in Blood (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.