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

June 3, 2026 updated by: Miracle Wellness LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
920

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Lutherville-Timonium, Maryland, United States, 21093
        • Natural Migraceuticals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 1 through Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 1 through Month 6
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.
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
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
Time Frame: Baseline, Month 1 through Month 6
Mean monthly number of migraine symptoms.
Baseline, Month 1 through Month 6
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
Baseline, Month 1 through Month 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
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
Number of missed work and/or school days per month (self-reported)
Baseline, Month 1 through Month 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in systemic CGRP concentrations
Time Frame: Baseline, Month 1 through Month 6
Mean systemic CGRP concentrations.
Baseline, Month 1 through Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Miracle Wellness LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings