MigraineNCT07634146
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 study testing Foundational dietary supplement, Luteal phase dietary supplement add-on and Migraine phase dietary supplement add-on in people with Migraine and Migraine Disease, run by Miracle Wellness LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Migraine Disease, Migraine Disorder
- What is being tested?
- Foundational dietary supplement, Luteal phase dietary supplement add-on and Migraine phase dietary supplement add-on
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 920 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Natural Migraceuticals
Lutherville-Timonium, Maryland, 21093
Principal Investigator, 443-220-3558, info@migraceutics.com
About this study
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
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 Disability, Migraine in Adults
- Being tested
- Foundational dietary supplement, Luteal phase dietary supplement add-on, Migraine phase dietary supplement add-on, Reference dietary supplement
- Keywords
- quality of life, productivity, disability, CGRP, headache, migraine, nutraceuticals, dietary supplement, migraceuticals
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foundational dietary supplementDietary supplement
Foundational dietary supplement, self-administered daily.
Luteal phase dietary supplement add-onDietary 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-onDietary supplement
Add-on dietary supplement, self-administered during the symptomatic migraine phase.
Reference dietary supplementDietary supplement
Reference comparator supplement, self-administered daily.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Care as usual (CAU) | No intervention | Not described |
| Arm 2 - Care as usual (CAU) + Reference dietary supplement | Sham comparator | Not described Receives: Dietary Supplement: Reference dietary supplement |
| Arm 3 - Care as usual (CAU) + Foundational dietary supplement | Other | Not described Receives: Dietary Supplement: Foundational dietary supplement |
| Arm 4a - Care as usual (CAU) + Foundational dietary supplement + Migraine phase add-on supplement | Other | Not described Receives: 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 | Not described Receives: Dietary Supplement: Foundational dietary supplement; Dietary Supplement: Luteal phase dietary supplement add-on |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 1 through Month 6
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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
Measured: Baseline, Month 1 through Month 6
Migraine symptoms participants experienced
Mean monthly number of migraine symptoms.
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline, Month 1 through Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start8 Jul 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miracle Wellness LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634146
- Sponsor's protocol ID
- 2026-0040
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07634146
- Acronym / sponsor ID
- 2026-0040
- Conditions
- Migraine, Migraine Disease, Migraine Disorder, Migraine Headache, Migraine Disability, Migraine in Adults
- Keywords
- quality of life, productivity, disability, CGRP, headache, migraine, nutraceuticals, dietary supplement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 920 participants (estimated)
- Lead sponsor
- Miracle Wellness LLCUniversity, hospital or other
- Study start
- 8 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foundational dietary supplementFoundational dietary supplement, self-administered daily. | Dietary supplement | 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-onAdd-on dietary supplement, self-administered to women with menstrual migraine during the luteal phase of their menstruation cycle. | Dietary supplement | Arm 4b - Care as usual (CAU) + Foundational dietary supplement + Luteal phase add-on supplement |
| Migraine phase dietary supplement add-onAdd-on dietary supplement, self-administered during the symptomatic migraine phase. | Dietary supplement | Arm 4a - Care as usual (CAU) + Foundational dietary supplement + Migraine phase add-on supplement |
| Reference dietary supplementReference comparator supplement, self-administered daily. | Dietary supplement | Arm 2 - Care as usual (CAU) + Reference dietary supplement |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foundational dietary supplement, Luteal phase dietary supplement add-on and Migraine phase dietary supplement add-on in people with Migraine and Migraine Disease, run by Miracle Wellness LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (443-220-3558, info@migraceutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in migraine-related quality of life (time frame: Baseline, Month 1 through Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.