Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 720
- Locations
- 29
- Primary Endpoint
- Frequency of Moderate to Severe Headache Days
Study Overview
Brief Summary
There are two commonly used treatment strategies for treating patients who have chronic migraine with medication overuse. This study will compare the outcomes amongst patients randomized to one of the two treatment strategies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults, at least 21 years of age
- •Chronic Migraine - diagnosed according to ICHD3beta criteria
- •Medication Overuse - diagnosed according to ICHD3beta criteria
- •Willingness to be randomized to either of the two treatment arms
- •Willingness to maintain a headache diary
- •Plan for follow-up care with the clinician
- •No changes to migraine prophylactic therapy within the 4 weeks prior to randomization.
Exclusion Criteria
- •Younger than 21 years of age
- •Headache diagnoses other than chronic migraine with medication overuse; episodic tension-type headache on 3 or fewer days per month is allowed
- •Not willing to be randomized to either of the treatment arms
- •Not willing to maintain a daily headache diary
- •Not planning on follow-up care with the clinician
- •In the opinion of the clinician, randomization to either treatment arm would be considered unsafe (ex: pregnancy, immediate discontinuation
- •Prisoners
- •Diminished decision-making capacity which in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
Arms & Interventions
Discontinuation
Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)
Intervention: Discontinuation of Overused Medication (Other)
Preventive Therapy Only
Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)
Intervention: Migraine Prophylactic Therapy Only (Other)
Outcomes
Primary Outcomes
Frequency of Moderate to Severe Headache Days
Time Frame: 12 weeks
Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity
Secondary Outcomes
No secondary outcomes reported
Investigators
Todd J. Schwedt
PI
Mayo Clinic