An interventional study of Migraine Prophylactic Therapy Only and Discontinuation of Overused Medication in Migraine, sponsored by Mayo Clinic. Completed at 29 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-11-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria
Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)
Other: Discontinuation of Overused Medication
Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)
Other: Migraine Prophylactic Therapy Only
Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy
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
| Milestone | Discontinuation | Preventive Therapy Only |
|---|---|---|
| Started | 361 | 359 |
| Completed | 310 | 310 |
| Not completed | 51 | 49 |
| Withdrew: Withdrawal by subject | 35 | 38 |
| Withdrew: Protocol violation | 11 | 6 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Health issues unable to continue | 2 | 0 |
| Withdrew: Did not meet inclusion criteria | 1 | 0 |
| Withdrew: Subject moved | 0 | 2 |
| Withdrew: Overused medication unavailable | 0 | 1 |
| Withdrew: Seeking care outside site | 0 | 1 |
| Withdrew: Technology barriers | 0 | 1 |
Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity
| days | Discontinuation | Preventive Therapy Only |
|---|---|---|
| Frequency of Moderate to Severe Headache Days | 9.3 ± 7.2 | 9.1 ± 6.8 |
Collected over Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Discontinuation | 0/361 (0%) | 7/361 (1.9%) | 20/361 (5.5%) |
| Preventive Therapy Only | 1/359 (0.3%) | 7/359 (1.9%) | 16/359 (4.5%) |
| Event | Discontinuation | Preventive Therapy Only |
|---|---|---|
| FractureMusculoskeletal and connective tissue disorders | 0/361 | 2/359 |
| AnemiaBlood and lymphatic system disorders | 0/361 | 1/359 |
| AnxietyPsychiatric disorders | 0/361 | 1/359 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/361 | 1/359 |
| FatigueGeneral disorders | 0/361 | 1/359 |
| Joint Range of Motion Decrease Cervical SpineMusculoskeletal and connective tissue disorders | 0/361 | 1/359 |
| Non-Cardiac Chest PainGeneral disorders | 0/361 | 1/359 |
| PalpitationsCardiac disorders | 0/361 | 1/359 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/361 | 1/359 |
| SepsisInfections and infestations | 0/361 | 1/359 |
| Event | Discontinuation | Preventive Therapy Only |
|---|---|---|
| ParesthesiaNervous system disorders | 7/361 | 4/359 |
| Weight GainInvestigations | 1/361 | 6/359 |
| Headache WorsenedNervous system disorders | 6/361 | 5/359 |
| FatigueGeneral disorders | 4/361 | 2/359 |
| SinusitisInfections and infestations | 4/361 | 0/359 |
| Age, Continuous(years) | Discontinuation | Preventive Therapy Only | Total |
|---|---|---|---|
| Mean | 45 ± 13 | 44 ± 13 | 44 ± 13 |
| Sex: Female, Male(Participants) | Discontinuation | Preventive Therapy Only | Total |
|---|---|---|---|
| Female | 313 | 317 | 630 |
| Male | 48 | 42 | 90 |
| Race/Ethnicity, Customized(Participants) | Discontinuation | Preventive Therapy Only | Total |
|---|---|---|---|
| White Non-Hispanic | 270 | 273 | 543 |
| Other | 91 | 86 | 177 |
| Region of Enrollment(participants) | Discontinuation | Preventive Therapy Only | Total |
|---|---|---|---|
| United States | 361 | 359 | 720 |
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