MigraineNCT07698249
Headache Diary for Migraine Patients
A study testing Headache diary in people with Migraine, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
Use of a headache journal/calendar in patients who have migraine to ascertain if keeping a headache journal affects the quality of life and the headache burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Headache diary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2025to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults diagnosed with migraine (episodic or chronic) according to ICHD-3 criteria, with at least 3 months of confirmed diagnosis. Both episodic migraine (≤14 headache days/month) and chronic migraine (≥15 headache days/month) are eligible and will be recorded as a demographic subgroup variable.
Who cannot join
- Individuals under the age of 18
- Non-English speaking individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hackensack Meridian Health - JFK Medical Center
Edison, New Jersey, 08820
About this study
Official title: Use of a Headache Calendar/Journal in Patients Who Have Migraine
Use of a headache journal/calendar in patients who have migraine to ascertain if keeping a headache journal affects the quality of life and the headache burden.
- Conditions
- Migraine
- Being tested
- Headache diary
- Keywords
- migraine, diary, calendar
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headache diaryBehavioural
Completion of the virtual diary/calendar
| Study group | Role | What they receive |
|---|---|---|
| Headache diary | Experimental | Virtual headache calendar/journal is given to migraine patients to see if it affects their migraine burden. Surveys are completed virtually at baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. Receives: Behavioral: Headache diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Specific Quality of Life
Migraine Specific Quality of Life using the MSQv2.1, a 14-item validated assessment used to measure how migraines affect a patient's daily functioning and well-being. Each of the 14 questions is scored using a 6-point scale ranging from 1 ("Always") to 6 ("Never"). The raw scores for each of the three domains are transformed into a standardized 0 to 100 scale, where higher scores indicate a better quality of life (less impact/disability from migraine).
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Secondary outcomes (1)
Migraine Disability Assessment (MIDAS) score
To determine whether headache burden has decreased, as measured by the Migraine Disability Assessment (MIDAS). MIDAS is a standard questionnaire used by neurologists and primary care providers to measure how severely migraines impact your daily life and work capacity. Scores range from 0 (no disability) to 21+ (severe disability) based on the number of days from a migraine event.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start14 Jan 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Gerhardstein, MD, MPH, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698249
- Sponsor's protocol ID
- Pro2024-0201
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 20 Jul 2026
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Headache Calendar/Journal in Patients Who Have Migraine
- ClinicalTrials.gov ID
- NCT07698249
- Acronym / sponsor ID
- Pro2024-0201
- Conditions
- Migraine
- Keywords
- migraine, diary, calendar
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 13 Jul 2026 (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.
Use of a headache journal/calendar in patients who have migraine to ascertain if keeping a headache journal affects the quality of life and the headache burden.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Headache diary | Experimental | Behavioral: Headache diaryVirtual headache calendar/journal is given to migraine patients to see if it affects their migraine burden. Surveys are completed virtually at baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults diagnosed with migraine (episodic or chronic) according to ICHD-3 criteria, with at least 3 months of confirmed diagnosis. Both episodic migraine (≤14 headache days/month) and chronic migraine (≥15 headache days/month) are eligible and will be recorded as a demographic subgroup variable.
Key exclusion criteria (2 listed)
- Individuals under the age of 18
- Non-English speaking individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Headache diaryCompletion of the virtual diary/calendar | Behavioural | Headache diary |
Primary outcome
Migraine Specific Quality of Life
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Migraine Specific Quality of Life using the MSQv2.1, a 14-item validated assessment used to measure how migraines affect a patient's daily functioning and well-being. Each of the 14 questions is scored using a 6-point scale ranging from 1 ("Always") to 6 ("Never"). The raw scores for each of the three domains are transformed into a standardized 0 to 100 scale, where higher scores indicate a better quality of life (less impact/disability from migraine).
1 secondary outcome
Migraine Disability Assessment (MIDAS) score
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Brian Gerhardstein, MD, MPH principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headache diary in people with Migraine, run by Hackensack Meridian Health 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 2 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: enrolling by invitation, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Migraine Specific Quality of Life (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks). 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 20 Jul 2026.