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Enrolling by Invitation

NCT Number: NCT07698249

Headache Diary for Migraine Patients

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.

Enrolling by Invitation

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack Meridian Health - JFK Medical Center

Edison, New Jersey, 08820, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Individuals under the age of 18
  • Non-English speaking individuals

Treatment and study plan

Headache diary

Behavioral

Completion of the virtual diary/calendar

Primary outcomes

  1. 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).

Secondary outcomes

  1. Migraine Disability Assessment (MIDAS) score

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Registry information

Official study title

Use of a Headache Calendar/Journal in Patients Who Have Migraine

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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