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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine; Migraine Headache; Menstrual Migraine; Menstrual Migraine (MM) Headaches; Migraine Disorder; Migraine in Adults; Migraine Disease; Migraine Disability
• Intervention / Treatment: Dietary supplement: Reference dietary supplement; Dietary supplement: Foundational dietary supplement; Dietary supplement: Migraine phase dietary supplement add-on; Dietary supplement: Luteal phase dietary supplement add-on

• Study Type: Interventional
• Enrollment (Estimated): 920
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: 443-220-3558; Email: info@migraceutics.com

Study Locations

• United States
  • Maryland
    • Lutherville-Timonium, Maryland, United States, 21093
      • Natural Migraceuticals
      • Contact: Principal Investigator; Phone Number: 443-220-3558; Email: info@migraceutics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1 - Care as usual (CAU)
Sham Comparator: Arm 2 - Care as usual (CAU) + Reference dietary supplement	Dietary supplement: Reference dietary supplement; Reference comparator supplement, self-administered daily.
Other: Arm 3 - Care as usual (CAU) + Foundational dietary supplement	Dietary supplement: Foundational dietary supplement; Foundational dietary supplement, self-administered daily.
Other: Arm 4a - Care as usual (CAU) + Foundational dietary supplement + Migraine phase add-on supplement	Dietary supplement: Foundational dietary supplement; Foundational dietary supplement, self-administered daily.; Dietary supplement: Migraine phase dietary supplement add-on; Add-on dietary supplement, self-administered during the symptomatic migraine phase.
Other: Arm 4b - Care as usual (CAU) + Foundational dietary supplement + Luteal phase add-on supplement	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in migraine-related quality of life	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.	Baseline, Month 1 through Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of self-reported migraine days per month	The number of calendar days within a 28-day (or pre-specified) period on which a participant experiences any migraine.	Baseline, Month 1 through Month 6
Distribution of participants experiencing changes in monthly migraine days	Distribution of participants in various levels of change (e.g., ≥25%, ≥50%, ≥75%, 100% change) from baseline.	Baseline, Month 1 through Month 6
Use of over-the-counter or prescription migraine or headache medication	Mean number of migraine days associated with use of over-the-counter or prescription migraine or headache medication	Baseline, Month 1 through Month 6
Migraine symptoms participants experienced	Mean monthly number of migraine symptoms.	Baseline, Month 1 through Month 6
Self-reported migraine symptom severity	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	Baseline, Month 1 through Month 6
Mean number of migraine hours	Mean number of hours in the past 30 days on which a migraine occurred	Baseline, Month 1 through Month 6
Number of missed work and/or school days due to migraine	Number of missed work and/or school days per month (self-reported)	Baseline, Month 1 through Month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in systemic CGRP concentrations	Mean systemic CGRP concentrations.	Baseline, Month 1 through Month 6

Collaborators and Investigators

• Sponsor: Miracle Wellness LLC

Study record dates

Study Major Dates

• Study Start (Estimated): July 8, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; dietary supplement; headache; disability; migraine; CGRP; nutraceuticals; productivity; migraceuticals
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Headache
• Other Study ID Numbers: 2026-0040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No