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Not yet recruiting 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

No phase Interventional Migraine Migraine Disease Migraine Disorder Migraine Headache

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Foundational dietary supplement, Luteal phase dietary supplement add-on, Migraine phase dietary supplement add-on, Reference dietary supplement.
Who it may be relevant to
Registry conditions: Migraine, Migraine Disease, Migraine Disorder, Migraine Headache. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Dietary supplement Foundational dietary supplement
    Foundational dietary supplement, self-administered daily.
  • Dietary supplement Luteal phase dietary supplement add-on
    Add-on dietary supplement, self-administered to women with menstrual migraine during the luteal phase of their menstruation cycle.
  • Dietary supplement Migraine phase dietary supplement add-on
    Add-on dietary supplement, self-administered during the symptomatic migraine phase.
  • Dietary supplement Reference dietary supplement
    Reference comparator supplement, self-administered daily.

Primary outcome measures

  • Changes from baseline in migraine-related quality of life [Time frame: Baseline, Month 1 through Month 6]
Secondary outcome measures (7)
  • Number of self-reported migraine days per month [Time frame: Baseline, Month 1 through Month 6]
  • Distribution of participants experiencing changes in monthly migraine days [Time frame: Baseline, Month 1 through Month 6]
  • Use of over-the-counter or prescription migraine or headache medication [Time frame: Baseline, Month 1 through Month 6]
  • Migraine symptoms participants experienced [Time frame: Baseline, Month 1 through Month 6]
  • Self-reported migraine symptom severity [Time frame: Baseline, Month 1 through Month 6]
  • Mean number of migraine hours [Time frame: Baseline, Month 1 through Month 6]
  • Number of missed work and/or school days due to migraine [Time frame: Baseline, Month 1 through Month 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Natural Migraceuticals — Lutherville-Timonium

Identifiers

NCT: NCT07634146 · 2026-0040

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗