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
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Among 17 studies in Migraine Disorders by Mayo Clinic — 5 open to participants now, 7 under way, none of them phase 3. Migraine Disorders · Mayo Clinic.
Among the 17 studies in Migraine Disorders by Mayo Clinic, this one is the 2nd largest by enrollment of the 15 interventional ones that give a count, is the only one that started in 2017, is one of 6 with no phase, and was the 5th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →5 of the 17 studies in Migraine Disorders by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18–70
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 720 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 50 across the 15 interventional studies, 34,356 across the 2 observational. Of the 8 that completed or were terminated, 5 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
4 of the studies in Migraine Disorders by Mayo Clinic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05734625Mayo ClinicEfficacy of Nerve Blocks for Episodic Migraine | 2027-02 |
| NCT06401642Mayo ClinicEffectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications | 2027-03 |
| NCT05415020Mayo ClinicDetermining the Utility of a Behavioral Intervention in Chronic Migraine | 2027-05-31 |
| NCT05755945Mayo ClinicA Study of Wearable Devices to Predict Migraines | 2027-06 |
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Among the 17 studies in Migraine Disorders by Mayo Clinic, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2017 to primary completion in Mar 2021, 50 months.
Results were first posted in Nov 2021, 7 months after primary completion.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 50 months is above that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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