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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI | Other Grant/Funding Number | PCS-1504-30133 |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discontinuation | Active Comparator | Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) |
|
| Preventive Therapy Only | Active Comparator | Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Migraine Prophylactic Therapy Only | Other | Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Todd J Schwedt, MD | Mayo Clinic | Principal Investigator |
| David W Dodick, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Arizona Healthcare Medical Group | Flagstaff | Arizona | 86001 | United States | ||
| Mayo Clinic in Arizona Headache Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38663902 | Derived | Whitaker DJ, Dumkrieger GM, Hentz JG, Dodick DW, Schwedt TJ. Physical impairment during and between migraine attacks: A daily diary study of patients with chronic migraine. Cephalalgia. 2024 Apr;44(4):3331024241249747. doi: 10.1177/03331024241249747. | |
| 35169011 | Derived | Schwedt TJ, Hentz JG, Sahai-Srivastava S, Murinova N, Spare NM, Treppendahl C, Martin VT, Birlea M, Digre K, Watson D, Leonard M, Robert T, Dodick DW; MOTS Investigators. Patient-Centered Treatment of Chronic Migraine With Medication Overuse: A Prospective, Randomized, Pragmatic Clinical Trial. Neurology. 2022 Apr 5;98(14):e1409-e1421. doi: 10.1212/WNL.0000000000200117. Epub 2022 Feb 15. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2020 |
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| Discontinuation of Overused Medication | Other | Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy |
|
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Mayo Clinic in Arizona Neurology Center | Phoenix | Arizona | 85054 | United States |
| Honor Health Neurology | Scottsdale | Arizona | 85251 | United States |
| Mayo Clinic Thunderbird | Scottsdale | Arizona | 85260 | United States |
| Keck Medical Center of USC | Los Angeles | California | 90033 | United States |
| University of Colorado Denver Headache Center | Aurora | Colorado | 80045 | United States |
| University of Colorado Denver Primary Center | Denver | Colorado | 80238 | United States |
| Blue Sky Neurology | Greenwood Village | Colorado | 80111 | United States |
| Memorial Healthcare | Hollywood | Florida | 33021 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| Norton Neurology | Louisville | Kentucky | 40207 | United States |
| Brigham Women's Hospital Headache Clinic | Boston | Massachusetts | 02130 | United States |
| Brigham Women's Hospital Neurology Clinic | Boston | Massachusetts | 02130 | United States |
| Henry Ford Allegiance Health | Jackson | Michigan | 49201 | United States |
| Mayo Clinic Headache Center | Rochester | Minnesota | 55905 | United States |
| The Headache Center | Ridgeland | Mississippi | 39157 | United States |
| Clinvest Research | Springfield | Missouri | 65801 | United States |
| University of Cincinnati Neurology | Cincinnati | Ohio | 45417 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Cincinnati Headache Center | Dayton | Ohio | 45417 | United States |
| Toledo Clinic Adult Neurology | Toledo | Ohio | 43623 | United States |
| Thomas Jefferson University Hospital Headache Center | Philadelphia | Pennsylvania | 19107 | United States |
| Preferred Headache Center | Pittsburgh | Pennsylvania | 15236 | United States |
| University of Utah Primary Care | Salt Lake City | Utah | 84106 | United States |
| University of Utah General Neurology | Salt Lake City | Utah | 84108 | United States |
| University of Utah Headache Center | Salt Lake City | Utah | 84132 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| West Virginia University Neurology | Morgantown | West Virginia | 26506 | United States |
| 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) |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | days | 12 weeks |
|
|
|
Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 361 | 7 | 361 | 20 | 361 |
| EG001 | 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) | 1 | 359 | 7 | 359 | 16 | 359 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Cecal Volvulus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
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| Headache Worsened | Nervous system disorders | Systematic Assessment |
| ||
| Joint Range of Motion Decrease Cervical Spine | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Left Ventricular Systolic Dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Non-Cardiac Chest Pain | General disorders | Systematic Assessment |
| ||
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Surgical Procedure - Spine | Surgical and medical procedures | Systematic Assessment |
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| Thromboembolic Event | Vascular disorders | Systematic Assessment |
| ||
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Weight Gain | Investigations | Systematic Assessment |
| ||
| Headache Worsened | Nervous system disorders | Systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Todd J. Schwedt | Mayo Clinic | 480-301-9443 | Schwedt.Todd@mayo.edu |
| Apr 28, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Male |
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| Other |
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