Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Migraine
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

This is a single group, multicenter, open-label study with a study population of patients who meet International Classification of Headache Disorders 3rd edition (ICHD-III) criteria for migraine with or without aura and have 4 to 20 migraine days per month. This is a single-group supportive care stu...

This is a single group, multicenter, open-label study with a study population of patients who meet International Classification of Headache Disorders 3rd edition (ICHD-III) criteria for migraine with or without aura and have 4 to 20 migraine days per month. This is a single-group supportive care study with one arm and no masking. A maximum of 54 participants will be enrolled to study intervention. All participants in this single-group study will complete a 4-week run-in period. After the run-in period, eligible participants will be enrolled to study intervention and enter a 12-week treatment period.

Tracking Information

NCT #
NCT04465357
Collaborators
  • Clinvest Research, LLC
  • Smith, Timothy R., M.D.
Investigators
Principal Investigator: Merle Diamond, MD Diamond Headache Clinic