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

NCT07634146 | Not Yet Recruiting

• 1 other identifier: 2026-0040
• Study Type: interventional
• Target: 920
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine; Migraine Disease; Migraine Disorder; Migraine Headache; Migraine in Adults; Menstrual Migraine; Migraine Disability; Menstrual Migraine (MM) Headaches

Keywords

quality of life; productivity; disability; CGRP; headache; migraine; nutraceuticals; dietary supplement; migraceuticals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of self-reported migraine days per month

  Baseline, Month 1 through Month 6

• Distribution of participants experiencing changes in monthly migraine days

  Baseline, Month 1 through Month 6

• Use of over-the-counter or prescription migraine or headache medication

  Baseline, Month 1 through Month 6

• Migraine symptoms participants experienced

  Baseline, Month 1 through Month 6

• Self-reported migraine symptom severity

  Baseline, Month 1 through Month 6

Other Outcomes (1)

• Change from baseline in systemic CGRP concentrations

  Baseline, Month 1 through Month 6

Study Arms (5)

Arm 1 - Care as usual (CAU)

NO INTERVENTION

Arm 2 - Care as usual (CAU) + Reference dietary supplement

SHAM COMPARATOR

Dietary Supplement: Reference dietary supplement

Arm 3 - Care as usual (CAU) + Foundational dietary supplement

OTHER

Dietary Supplement: Foundational dietary supplement

Arm 4a - Care as usual (CAU) + Foundational dietary supplement + Migraine phase add-on supplement

OTHER

Dietary Supplement: Foundational dietary supplement; Dietary Supplement: Migraine phase dietary supplement add-on

Arm 4b - Care as usual (CAU) + Foundational dietary supplement + Luteal phase add-on supplement

OTHER

Dietary Supplement: Foundational dietary supplement; Dietary Supplement: Luteal phase dietary supplement add-on

Interventions

Foundational dietary supplement DIETARY_SUPPLEMENT

Foundational dietary supplement, self-administered daily.

Arm 3 - Care as usual (CAU) + Foundational dietary supplement; Arm 4a - Care as usual (CAU) + Foundational dietary supplement + Migraine phase add-on supplement; Arm 4b - Care as usual (CAU) + Foundational dietary supplement + Luteal phase add-on supplement

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.

Arm 4b - Care as usual (CAU) + Foundational dietary supplement + Luteal phase add-on supplement

Migraine phase dietary supplement add-on DIETARY_SUPPLEMENT

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

Arm 4a - Care as usual (CAU) + Foundational dietary supplement + Migraine phase add-on supplement

Reference dietary supplement DIETARY_SUPPLEMENT

Reference comparator supplement, self-administered daily.

Arm 2 - Care as usual (CAU) + Reference dietary supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Miracle Wellness LLC: lead

Study Sites (1)

Natural Migraceuticals

Lutherville-Timonium, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Principal Investigator

CONTACT

443-220-3558; info@migraceutics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 8, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-05

Locations

US (1)