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The study was terminated due to enrolment challenges.
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The purpose of this study is to examine how eptinezumab compares to other advanced preventive medications in a real-world community setting in adult participants with episodic migraine (EM) or chronic migraine (CM). These objectives include exploring the comparative effectiveness on patient reported outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptinezumab | Experimental | Participants will receive eptinezumab via intravenous (IV) infusion on Day 0 and Day 84. |
|
| Anti-CGRP injectables | Experimental | Participants are free to select treatment from one of 3 calcitonin gene-related peptide (CGRP) inhibitors: erenumab, fremanezumab, or galcanezumab. CGRP inhibitors will be administered via subcutaneous (SC) injection on Day 0 and then, per product label. |
|
| Onabotulinumtoxin-A | Experimental | Onabotulinumtoxin-A will be administered via intramuscular (IM) injection on Day 0 and Day 84. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab | Drug | Concentrate for solution for IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24 | Participants select the symptom that they find most impairs them at the time of reporting and rate the severity of that symptom on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms. | Baseline, Week 24 |
| Number of "Good Days" From Baseline | The participants report the number of "good days" and "bad days" they had in the previous week on a weekly basis using the good day/bad day scale. | Up to Week 24 |
| Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L) Score at Week 24 | The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analog scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | Baseline, Week 24 |
| Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications | Up to Week 24 | |
| QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score | The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item is rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 is the sum of each response score ranging from 36 to 78. The life impact derived from the total score is described as follows: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gilbert Neurology Partners/ CCT Research | Gilbert | Arizona | 85297 | United States | ||
| Ki Clinical Research LLC, dba New England Institute for Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erenumab | Participants received erenumab SC every 28 days, as per the product label for 6 months. |
| FG001 | Fremanezumab | Participants received fremanezumab SC every 28 days or every 84 days, as per the product label for 6 months. |
| 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 | Yes | No | No | Study Protocol | Jul 7, 2022 | Feb 6, 2024 |
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| Erenumab | Drug | Solution for SC Injection |
|
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| Onabotulinumtoxin-A | Drug | Solution for IM Injection |
|
| Fremanezumab | Drug | Solution for SC Injection |
|
|
| Galcanezumab | Drug | Solution for SC Injection |
|
|
| Up to Week 24 |
| QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score | The Midas score is a participant completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. | Up to Week 24 |
| Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) | The TSQM assesses four domains of participants' satisfaction with treatment, with scale ranges from 0 (extremely dissatisfied) to 100 (not at all dissatisfied) for each of the categories (Effectiveness, Side Effects, Convenience, and Overall Satisfaction). | Week 24 |
| Percentage of Participants That Switch From the Preventive Medication They Are Randomized to at Baseline to Another Preventive Medication | Week 24 |
| Stamford |
| Connecticut |
| 06905 |
| United States |
| Innovation Medical Group | Palmetto Bay | Florida | 33157 | United States |
| The Headache Center | Ridgeland | Mississippi | 39157 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| North Kansas City Hospital | North Kansas City | Missouri | 64416 | United States |
| Dent Neurologic Institute - Amherst | Amherst | New York | 14226 | United States |
| Carolina Women's Research and Wellness Center | Durham | North Carolina | 27713 | United States |
| AIM Trials, LLC | Plano | Texas | 75093 | United States |
| Olympus Family Medicine/CCT Research | Salt Lake City | Utah | 84117 | United States |
| FG002 | Onabotulinumtoxin-A | Participants received onabotulinumtoxin-A SC at Baseline (Day 0) and Week 12. |
| FG003 | Galcanezumab | Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months. |
| FG004 | Eptinezumab | Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erenumab | Participants received erenumab SC every 28 days, as per the product label for 6 months. |
| BG001 | Fremanezumab | Participants received fremanezumab SC every 28 days or every 84 days, as per the product label for 6 months. |
| BG002 | Onabotulinumtoxin-A | Participants received onabotulinumtoxin-A SC at Baseline (Day 0) and Week 12. |
| BG003 | Galcanezumab | Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months. |
| BG004 | Eptinezumab | Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12. |
| BG005 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24 | Participants select the symptom that they find most impairs them at the time of reporting and rate the severity of that symptom on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms. | Analysis was performed on the full analysis set (FAS), which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons. | Posted | Baseline, Week 24 |
|
| |||||||||||||||||||||||||||||||
| Primary | Number of "Good Days" From Baseline | The participants report the number of "good days" and "bad days" they had in the previous week on a weekly basis using the good day/bad day scale. | Analysis was performed on the FAS, which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons. | Posted | Up to Week 24 |
| ||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L) Score at Week 24 | The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analog scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | Analysis was performed on the FAS, which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons. | Posted | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||
| Primary | Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications | Analysis was performed on the FAS, which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons. | Posted | Up to Week 24 |
| |||||||||||||||||||||||||||||||||
| Primary | QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score | The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item is rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 is the sum of each response score ranging from 36 to 78. The life impact derived from the total score is described as follows: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). | Analysis was performed on the FAS, which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons. | Posted | Up to Week 24 |
| ||||||||||||||||||||||||||||||||
| Primary | QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score | The Midas score is a participant completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. | Analysis was performed on the FAS, which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons. | Posted | Up to Week 24 |
| ||||||||||||||||||||||||||||||||
| Primary | Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) | The TSQM assesses four domains of participants' satisfaction with treatment, with scale ranges from 0 (extremely dissatisfied) to 100 (not at all dissatisfied) for each of the categories (Effectiveness, Side Effects, Convenience, and Overall Satisfaction). | Analysis was performed on the FAS, which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons. | Posted | Week 24 |
| ||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants That Switch From the Preventive Medication They Are Randomized to at Baseline to Another Preventive Medication | Analysis was performed on the FAS, which included all participants who completed at least one daily report after receiving eptinezumab or other advanced migraine therapy. Due to the small sample size, data was not reported for participant confidentiality reasons. | Posted | Week 24 |
|
Baseline up to Week 24
The safety population included all participants who received treatment.
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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 | Erenumab | Participants received erenumab SC every 28 days, as per the product label for 6 months. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | Fremanezumab | Participants received fremanezumab SC every 28 days or every 84 days, as per the product label for 6 months. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Onabotulinumtoxin-A | Participants received onabotulinumtoxin-A SC at Baseline (Day 0) and Week 12. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Galcanezumab | Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG004 | Eptinezumab | Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12. | 0 | 16 | 0 | 16 | 4 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pelvic floor dysfunction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
The study was terminated early due to enrolment challenges.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via | H. Lundbeck A/S | +4536301311 | LundbeckClinicalTrials@Lundbeck.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2022 | Feb 6, 2024 | SAP_001.pdf |
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| 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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| ID | Term |
|---|---|
| C000628361 | eptinezumab |
| C000605816 | erenumab |
| D019274 | Botulinum Toxins, Type A |
| C000604315 | fremanezumab |
| C000628360 | galcanezumab |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG004 | Eptinezumab | Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12. |
|
|
| OG003 | Galcanezumab | Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months. |
| OG004 | Eptinezumab | Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12. |
|
| Eptinezumab |
Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12. |
|
|
Participants received onabotulinumtoxin-A SC at Baseline (Day 0) and Week 12.
| OG003 | Galcanezumab | Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months. |
| OG004 | Eptinezumab | Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12. |
|
|
Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months. |
| OG004 | Eptinezumab | Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12. |
|
|
Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months. |
| OG004 | Eptinezumab | Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12. |
|
| Galcanezumab |
Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months. |
|