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NCT Number: NCT07634146

Evaluation of the Migraceutics® Phase-Specific Dietary Supplement Regimen on Quality of Life, Work Productivity, and Biomarkers in Adult Migraineurs: The Migraceutics® START Study

The purpose of this study is to evaluate the impact of the Migraceutics® phase-specific dietary supplement regimen on quality of life, work productivity, and biomarkers in adult migraineurs.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Menstrual Migraine Menstrual Migraine (MM) Headaches Migraine Disability Migraine Disease Migraine Disorder Migraine Disorders Migraine Headache Migraine in Adults Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Natural Migraceuticals

Lutherville-Timonium, Maryland, 21093, United States

Location contact

Principal Investigator

CONTACT

[email protected]

443-220-3558

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Self-reported history of migraine, based on the International Headache Society (IHS) International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria for migraine.
  • Being able to take oral supplements.
  • Agreeing to maintain their regular lifestyle.
  • Access to internet and telephone.

Exclusion criteria

  • Pregnancy or lactation.
  • Presence of any active medical condition or diagnosis other than episodic migraine, including liver or kidney disease or condition.
  • Use of overlapping supplements or interacting medications.
  • Known allergies to study ingredients.
  • Daily use of alcohol, tobacco, or recreational drugs.
  • Participation in any other clinical or interventional study within 30 days prior to baseline or concurrently.

Treatment and study plan

Foundational dietary supplement

Dietary Supplement

Foundational dietary supplement, self-administered daily.

Luteal phase dietary supplement add-on

Dietary Supplement

Add-on dietary supplement, self-administered to women with menstrual migraine during the luteal phase of their menstruation cycle.

Migraine phase dietary supplement add-on

Dietary Supplement

Add-on dietary supplement, self-administered during the symptomatic migraine phase.

Reference dietary supplement

Dietary Supplement

Reference comparator supplement, self-administered daily.

Primary outcomes

  1. Changes from baseline in migraine-related quality of life

    Time frame: Baseline, Month 1 through Month 6

    Changes from baseline in migraine-related quality of life as measured by the mean Headache Impact Test (HIT-6) total score. HIT-6 has six questions, which are rated using a five-level scale: Never (6 points), Rarely (8 points), Sometimes (10 points), Very Often (11 points), and Always (13 points). Total scores can range from 36 to 78, with higher totals reflecting a more significant impact.

Secondary outcomes

  1. Number of self-reported migraine days per month

    Time frame: Baseline, Month 1 through Month 6

    The number of calendar days within a 28-day (or pre-specified) period on which a participant experiences any migraine.

  2. Distribution of participants experiencing changes in monthly migraine days

    Time frame: Baseline, Month 1 through Month 6

    Distribution of participants in various levels of change (e.g., ≥25%, ≥50%, ≥75%, 100% change) from baseline.

  3. Use of over-the-counter or prescription migraine or headache medication

    Time frame: Baseline, Month 1 through Month 6

    Mean number of migraine days associated with use of over-the-counter or prescription migraine or headache medication

  4. Migraine symptoms participants experienced

    Time frame: Baseline, Month 1 through Month 6

    Mean monthly number of migraine symptoms.

  5. Self-reported migraine symptom severity

    Time frame: Baseline, Month 1 through Month 6

    Self-reported migraine symptom severity scores. Participants rate each of their reported symptoms on a scale from 0 to 10 how bad these symptoms were at their worst. 0: I did not have this symptom, and 10: it was the worst imaginable

  6. Mean number of migraine hours

    Time frame: Baseline, Month 1 through Month 6

    Mean number of hours in the past 30 days on which a migraine occurred

  7. Number of missed work and/or school days due to migraine

    Time frame: Baseline, Month 1 through Month 6

    Number of missed work and/or school days per month (self-reported)

Other outcomes

  1. Change from baseline in systemic CGRP concentrations

    Time frame: Baseline, Month 1 through Month 6

    Mean systemic CGRP concentrations.

Study contacts

Contact information is provided by the study sponsor or research team.

Principal Investigator

CONTACT

[email protected]

443-220-3558

Sponsors and collaborators

Lead sponsor

Miracle Wellness LLC

Other

Registry information

Official study title

A Randomized, Sham Supplement- and Care-as-Usual-Controlled Study to Evaluate Migraceutics® Phase-Specific Dietary Supplement Regimen on Quality of Life, Work Productivity, and Biomarkers in Adult Migraineurs: The Migraceutics® START Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 8, 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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