Migraine
Conditions
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.
Interventions
OTHERMigraine Prophylactic Therapy Only
Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
OTHERDiscontinuation of Overused Medication
Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy
Sponsors
Patient-Centered Outcomes Research Institute
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Moderate to Severe Headache Days | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Discontinuation Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)
Discontinuation of Overused Medication: Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy | 361 |
| Preventive Therapy Only Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)
Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s) | 359 |
| Total | 720 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Did not meet inclusion criteria | 1 | 0 |
| Overall Study | Health Issues unable to continue | 2 | 0 |
| Overall Study | Overused medication unavailable | 0 | 1 |
| Overall Study | Protocol Violation | 11 | 6 |
| Overall Study | Seeking care outside site | 0 | 1 |
| Overall Study | Subject moved | 0 | 2 |
| Overall Study | Technology barriers | 0 | 1 |
| Overall Study | Withdrawal by Subject | 35 | 38 |
Baseline characteristics
| Characteristic | Discontinuation | Preventive Therapy Only | Total |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 13 |
| Race/Ethnicity, Customized Other | 91 Participants | 86 Participants | 177 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 270 Participants | 273 Participants | 543 Participants |
| Region of Enrollment United States | 361 participants | 359 participants | 720 participants |
| Sex: Female, Male Female | 313 Participants | 317 Participants | 630 Participants |
| Sex: Female, Male Male | 48 Participants | 42 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 361 | 1 / 359 |
| other Total, other adverse events | 20 / 361 | 16 / 359 |
| serious Total, serious adverse events | 7 / 361 | 7 / 359 |
Outcome results
Primary
Frequency of Moderate to Severe Headache Days
Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity
Time frame: 12 weeks
Population: Data not collected or analyzed on 16 subjects from the discontinuation arm. Data not collected or analyzed on 19 subjects from the preventive therapy only arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Discontinuation | Frequency of Moderate to Severe Headache Days | 9.3 days | Standard Deviation 7.2 |
| Preventive Therapy Only | Frequency of Moderate to Severe Headache Days | 9.1 days | Standard Deviation 6.8 |