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

Browse trials for

• Migraine Disorders 1,657
• Headache 762

Keywords

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

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 920 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.

Lead sponsor

This is the only study on the registry with Miracle Wellness LLC as lead sponsor.

Study arms

• No intervention
  Arm 1 - Care as usual (CAU)
• Sham comparator
  Arm 2 - Care as usual (CAU) + Reference dietary supplement

  Dietary Supplement: Reference dietary supplement

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

  Dietary Supplement: Foundational dietary supplement

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

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

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

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

Interventions

• Dietary supplementFoundational dietary supplement

  Foundational dietary supplement, self-administered daily.

• Dietary supplementLuteal 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 supplementMigraine phase dietary supplement add-on

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

• Dietary supplementReference dietary supplement

  Reference comparator supplement, self-administered daily.

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.

   Time frame: Baseline, Month 1 through Month 6

Secondary outcomes

1. 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.

   Time frame: Baseline, Month 1 through Month 6

2. 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.

   Time frame: Baseline, Month 1 through Month 6

3. 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

   Time frame: Baseline, Month 1 through Month 6

4. Migraine symptoms participants experienced

   Mean monthly number of migraine symptoms.

   Time frame: Baseline, Month 1 through Month 6

5. 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

   Time frame: Baseline, Month 1 through Month 6

6. Mean number of migraine hours

   Mean number of hours in the past 30 days on which a migraine occurred

   Time frame: Baseline, Month 1 through Month 6

7. Number of missed work and/or school days due to migraine

   Number of missed work and/or school days per month (self-reported)

   Time frame: Baseline, Month 1 through Month 6

Other outcomes

1. Change from baseline in systemic CGRP concentrations

   Mean systemic CGRP concentrations.

   Time frame: Baseline, Month 1 through Month 6

Individual participant data

Plan to share: Undecided