Migraine
Conditions
Brief summary
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.
Interventions
DRUGEptinezumab
Concentrate for solution for IV infusion
DRUGErenumab
Solution for SC Injection
DRUGOnabotulinumtoxin-A
Solution for IM Injection
DRUGFremanezumab
Solution for SC Injection
DRUGGalcanezumab
Solution for SC Injection
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of migraine per International Headache Society (IHS) International Classification of Headache Disorder (ICHD)-3 guidelines at least 12 months prior to screening. * Have a history of ≥ 8 migraine days/month in 2 of the previous 3 months as confirmed by the treating physician through medical records. * Be able to understand the clinical description of treatment options and have the capability to participate fully in making their treatment preferences known. * Be willing to accept randomization to any of the possible study medications if allocated to that treatment arm. * Be willing and capable of completing daily reports and other participant reported outcome measures using a smartphone-based application.
Exclusion criteria
* The participant has a history of severe drug allergy or hypersensitivity, or known hypersensitivity or intolerance to either eptinezumab, erenumab, fremanezumab, galcanezumab or their excipients. * The participant has previous history of use of any of the study drugs (for example, eptinezumab, Botox, erenumab, fremanezumab or galcanezumab). Note that only previous Botox use for treatment of migraine is exclusionary. Prior use of Botox for cosmetic purposes is allowed. * The participant has a diagnosis of CM and has hypersensitivity to botulinum toxin preparation or to any of the components in the formulation. * The participant has used opioids or butalbital-containing products greater than 4 days per month in the last month. Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24 | Baseline, 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. |
| Number of Good Days From Baseline | Up to Week 24 | 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. |
| 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 | Baseline, 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). |
| 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 | Up to Week 24 | 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). |
| QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score | Up to Week 24 | 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. |
| Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) | Week 24 | 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). |
| Percentage of Participants That Switch From the Preventive Medication They Are Randomized to at Baseline to Another Preventive Medication | Week 24 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erenumab Participants received erenumab SC every 28 days, as per the product label for 6 months. | 3 |
| Fremanezumab Participants received fremanezumab SC every 28 days or every 84 days, as per the product label for 6 months. | 2 |
| Onabotulinumtoxin-A Participants received onabotulinumtoxin-A SC at Baseline (Day 0) and Week 12. | 2 |
| Galcanezumab Participants received galcanezumab loading dose SC as applicable followed by dosing every 28 days, as per the product label for 5 months. | 8 |
| Eptinezumab Participants received eptinezumab via IV infusion, as per the product label at Baseline (Day 0) and Week 12. | 17 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 2 | 1 |
| Overall Study | Study terminated | 2 | 2 | 2 | 5 | 15 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Erenumab | Fremanezumab | Onabotulinumtoxin-A | Galcanezumab | Eptinezumab | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 47.3 years STANDARD_DEVIATION 6.4 | 60.5 years STANDARD_DEVIATION 4.9 | 30.5 years STANDARD_DEVIATION 17.7 | 43.1 years STANDARD_DEVIATION 12.6 | 38.2 years STANDARD_DEVIATION 10.5 | 41.2 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 7 Participants | 12 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 1 Participants | 1 Participants | 4 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 2 Participants | 6 Participants | 15 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 | 0 / 2 | 0 / 8 | 0 / 16 |
| other Total, other adverse events | 0 / 3 | 0 / 2 | 0 / 2 | 6 / 8 | 4 / 16 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 | 0 / 2 | 0 / 8 | 0 / 16 |
Outcome results
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.
Time frame: Baseline, Week 24
Population: 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.
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).
Time frame: Baseline, Week 24
Population: 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.
Primary
Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications
Time frame: Up to Week 24
Population: 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.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications | Week 4 | — |
| Unknown | Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications | Week 12 | — |
| Unknown | Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications | 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.
Time frame: Up to Week 24
Population: 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.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Number of Good Days From Baseline | Week 4 | — |
| Unknown | Number of Good Days From Baseline | Week 12 | — |
| Unknown | Number of Good Days From Baseline | 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).
Time frame: Week 24
Population: 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.
Primary
Percentage of Participants That Switch From the Preventive Medication They Are Randomized to at Baseline to Another Preventive Medication
Time frame: Week 24
Population: 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.
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).
Time frame: Up to Week 24
Population: 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.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score | Week 4 | — |
| Unknown | QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score | Week 12 | — |
| Unknown | QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score | 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.
Time frame: Up to Week 24
Population: 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.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score | Week 12 | — |
| Unknown | QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score | Week 24 | — |