A Phase 3 interventional study of Eptinezumab in Chronic Cluster Headache, sponsored by H. Lundbeck A/S. Completed at 31 sites in 9 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment
The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.
The participants who take part in this trial will be asked to stay in the trial for about a year. The participants will be asked to visit the trial site 7 times during the trial. In between trial site visits, they will have scheduled phone calls with the trial site staff. They will also be asked to keep track of their cluster headaches at home with a headache diary.
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Participants will receive 4 intravenous (IV) infusions with eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
Drug: Eptinezumab
Eptinezumab will be administered per schedule specified in the arm description.
Also known as: Vyepti
Number of Participants With Treatment-emergent Adverse Events (AEs)
A treatment-emergent AE was defined as any on-treatment untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 Consecutive Weeks)
Participants counted as converting from cCH to eCH if they had no CH attacks for at least 3 months.
Time frame: Week 1 to Week 48
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Abortive therapy was defined as oxygen and/or triptans, where it counted as 2 times if oxygen and triptans were used for the same attack.
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in the Average Number of Weekly Attacks
The participant completed a CH eDiary, daily, and record for each day/week whether he/she had any CH attacks.
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in the Number of Weekly Attacks
The average of the estimated change from baseline in the number of weekly attacks across the first 4 weeks after the infusion is shown.
Time frame: Baseline (Week 0), Weeks 1-4
Change From Baseline in the Number of Weekly Attacks
The average of the estimated change from baseline in the number of weekly attacks across the first 2 weeks after the infusion is shown.
Time frame: Baseline (Week 0), Weeks 1-2
Change From Baseline in the Number of Monthly Attacks
The average of the estimated change from baseline in the number of monthly attacks across the first 12 months after the infusion is shown.
Time frame: Baseline (Week 0), Months 1-12
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
The severity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating).
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks)
Participants counted as being in remission if they had no cluster headache attacks for at least 1 month.
Time frame: Week 1 to Week 48
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion)
Time frame: Week 1 to Week 12
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Second and Third Infusion)
Time frame: Week 13 to Week 24
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion)
Time frame: Week 25 to Week 36
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion)
Time frame: Week 37 to Week 48
Number of Participants Who Received a Transitional Therapy During the Treatment Period
Transitional treatments were defined as greater occipital nerve (GON) block or oral steroids.
Time frame: Week 1 to Week 48
Patient Global Impression of Change (PGIC) Score
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate better health status.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
The SIS is a patient-reported clinical outcome assessment used to assess quality of life resulting from sleep disturbance. The SIS questionnaire includes 35 items belonging to 7 domains to assess sleep impact on: daily activities; emotional well-being; emotional impact; energy/fatigue; social well-being; mental fatigue; and satisfaction with sleep. Each item, for 6 out of the 7 domains, is rated on a 5-point scale ranging from 1 (always or all of the time) to 5 (never or none of the time), whereas satisfaction with sleep is rated on a 5-point scale ranging from 1 (very satisfied) to 5 (very dissatisfied). Each domain yields a score ranging from 0 to 100, which is presented here. A higher score for Daily Activities, Emotional Well-being, Emotional Impact, Energy/Fatigue, Social Well-being, and Mental Fatigue indicates better quality of life. A lower score for Satisfaction with Sleep indicates a higher quality of life.
Time frame: Baseline (Week 0), Weeks 4, 12, 16, 24, 28, 36, 40, 48
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
The EQ-5D-5L is a patient-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). Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems).
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48
The EQ-5D-5L VAS is a participant-reported assessment designed to measure the participant's well-being and ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
The WPAI:GH2.0 is a patient self-rated clinical outcome assessment designed to provide a quantitative measure of the work productivity and activity impairment due to a health condition. The WPAI:GH2.0 assesses activities over the preceding 7 days and consists of 6 items: 1 item assesses employment (yes/no); 3 items assess the number of hours worked, the number of hours missed from work due to the participant's condition, or due to other reasons; and 2 visual numerical scales assess how much the participant's condition affects his/her productivity at work and his/her ability to complete normal daily activities. Each item (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) was calculated into an impairment percentage ranging from 0 to 100%, with higher numbers indicating greater impairment and less productivity (i.e. worse outcomes). Change from baseline for each item is shown here.
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Number of participants who visited a family doctor/general practitioner has been reported.
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Visits to a Specialist
Number of participants who visited a specialist has been reported.
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Number of participants who visited an emergency department due to CH has been reported.
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Number of participants admitted to the hospital due to CH has been reported.
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Number of participants who had overnight hospital stays due to CH has been reported.
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
| Milestone | Eptinezumab |
|---|---|
| Started | 131 |
| Received at least 1 dose of study drug | 131 |
| Completed | 108 |
| Not completed | 23 |
| Withdrew: Adverse event | 4 |
| Withdrew: Lack of efficacy | 12 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Other reasons | 3 |
A treatment-emergent AE was defined as any on-treatment untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | Eptinezumab |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) | 106 |
Participants counted as converting from cCH to eCH if they had no CH attacks for at least 3 months.
| Participants | Eptinezumab |
|---|---|
| Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 Consecutive Weeks) | 7 |
Abortive therapy was defined as oxygen and/or triptans, where it counted as 2 times if oxygen and triptans were used for the same attack.
| Abortive therapy use per week | Eptinezumab |
|---|---|
| Week 1 | -3.63 ± 0.53 |
| Week 2 | -4.24 ± 0.70 |
| Week 3 | -4.90 ± 0.76 |
| Week 4 | -4.99 ± 0.94 |
| Week 13 | -7.22 ± 0.84 |
| Week 14 | -6.83 ± 0.85 |
| Week 15 | -6.06 ± 0.84 |
| Week 16 | -6.42 ± 0.96 |
| Week 25 | -6.18 ± 0.99 |
| Week 26 | -6.56 ± 0.86 |
| Week 27 | -7.56 ± 0.82 |
| Week 28 | -7.12 ± 0.83 |
| Week 37 | -6.55 ± 0.98 |
| Week 38 | -6.97 ± 0.84 |
| Week 39 | -6.71 ± 1.04 |
| Week 40 | -7.09 ± 0.84 |
| Oxygen use per week | Eptinezumab |
|---|---|
| Week 1 | -1.72 ± 0.33 |
| Week 2 | -2.43 ± 0.40 |
| Week 3 | -3.17 ± 0.48 |
| Week 4 | -3.23 ± 0.59 |
| Week 13 | -3.97 ± 0.57 |
| Week 14 | -3.93 ± 0.56 |
| Week 15 | -3.09 ± 0.53 |
| Week 16 | -3.78 ± 0.61 |
| Week 25 | -3.56 ± 0.67 |
| Week 26 | -3.75 ± 0.58 |
| Week 27 | -4.06 ± 0.52 |
| Week 28 | -4.02 ± 0.54 |
| Week 37 | -3.60 ± 0.64 |
| Week 38 | -3.74 ± 0.52 |
| Week 39 | -3.99 ± 0.66 |
| Week 40 | -3.82 ± 0.55 |
| Triptans use per week | Eptinezumab |
|---|---|
| Week 1 | -1.75 ± 0.33 |
| Week 2 | -1.73 ± 0.42 |
| Week 3 | -1.74 ± 0.44 |
| Week 4 | -1.90 ± 0.45 |
| Week 13 | -2.94 ± 0.46 |
| Week 14 | -2.78 ± 0.50 |
| Week 15 | -2.81 ± 0.49 |
| Week 16 | -2.50 ± 0.51 |
| Week 25 | -2.05 ± 0.52 |
| Week 26 | -2.48 ± 0.48 |
| Week 27 | -3.06 ± 0.45 |
| Week 28 | -2.86 ± 0.46 |
| Week 37 | -2.55 ± 0.50 |
| Week 38 | -2.54 ± 0.49 |
| Week 39 | -2.52 ± 0.58 |
| Week 40 | -2.95 ± 0.54 |
The participant completed a CH eDiary, daily, and record for each day/week whether he/she had any CH attacks.
| Attacks per week | Eptinezumab |
|---|---|
| Week 1 | -3.00 ± 0.54 |
| Week 2 | -3.92 ± 0.79 |
| Week 3 | -4.51 ± 0.93 |
| Week 4 | -4.98 ± 1.18 |
| Week 13 | -6.18 ± 1.20 |
| Week 14 | -6.31 ± 1.15 |
| Week 15 | -5.81 ± 1.08 |
| Week 16 | -6.63 ± 1.24 |
| Week 25 | -5.56 ± 1.26 |
| Week 26 | -5.95 ± 1.27 |
| Week 27 | -7.09 ± 1.22 |
| Week 28 | -6.51 ± 1.31 |
| Week 37 | -6.25 ± 1.27 |
| Week 38 | -6.57 ± 1.14 |
| Week 39 | -5.99 ± 1.23 |
| Week 40 | -6.39 ± 1.15 |
The average of the estimated change from baseline in the number of weekly attacks across the first 4 weeks after the infusion is shown.
| Attacks per week | Eptinezumab |
|---|---|
| Change From Baseline in the Number of Weekly Attacks | -4.11 ± 0.79 |
The average of the estimated change from baseline in the number of weekly attacks across the first 2 weeks after the infusion is shown.
| Attacks per week | Eptinezumab |
|---|---|
| Change From Baseline in the Number of Weekly Attacks | -3.46 ± 0.61 |
The average of the estimated change from baseline in the number of monthly attacks across the first 12 months after the infusion is shown.
| Attacks per month | Eptinezumab |
|---|---|
| Change From Baseline in the Number of Monthly Attacks | -22.65 ± 4.39 |
The severity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating).
| score on a scale | Eptinezumab |
|---|---|
| Week 1 | -0.47 ± 0.06 |
| Week 2 | -0.51 ± 0.07 |
| Week 3 | -0.58 ± 0.07 |
| Week 4 | -0.59 ± 0.08 |
| Week 13 | -0.78 ± 0.09 |
| Week 14 | -0.75 ± 0.09 |
| Week 15 | -0.82 ± 0.08 |
| Week 16 | -0.90 ± 0.09 |
| Week 25 | -0.80 ± 0.09 |
| Week 26 | -0.79 ± 0.09 |
| Week 27 | -0.88 ± 0.09 |
| Week 28 | -0.84 ± 0.09 |
| Week 37 | -0.77 ± 0.09 |
| Week 38 | -0.79 ± 0.10 |
| Week 39 | -0.70 ± 0.10 |
| Week 40 | -0.79 ± 0.10 |
| Participants | Eptinezumab |
|---|---|
| Week 1 | 49 |
| Week 2 | 52 |
| Week 3 | 55 |
| Week 4 | 55 |
| Week 13 | 54 |
| Week 14 | 63 |
| Week 15 | 58 |
| Week 16 | 62 |
| Week 25 | 60 |
| Week 26 | 60 |
| Week 27 | 62 |
| Week 28 | 48 |
| Week 37 | 57 |
| Week 38 | 51 |
| Week 39 | 43 |
| Week 40 | 44 |
| Participants | Eptinezumab |
|---|---|
| Week 1 | 30 |
| Week 2 | 36 |
| Week 3 | 42 |
| Week 4 | 40 |
| Week 13 | 35 |
| Week 14 | 45 |
| Week 15 | 43 |
| Week 16 | 48 |
| Week 25 | 43 |
| Week 26 | 45 |
| Week 27 | 45 |
| Week 28 | 39 |
| Week 37 | 40 |
| Week 38 | 41 |
| Week 39 | 34 |
| Week 40 | 38 |
| Participants | Eptinezumab |
|---|---|
| Week 1 | 11 |
| Week 2 | 13 |
| Week 3 | 21 |
| Week 4 | 20 |
| Week 13 | 23 |
| Week 14 | 25 |
| Week 15 | 23 |
| Week 16 | 29 |
| Week 25 | 29 |
| Week 26 | 24 |
| Week 27 | 28 |
| Week 28 | 24 |
| Week 37 | 27 |
| Week 38 | 28 |
| Week 39 | 21 |
| Week 40 | 25 |
Participants counted as being in remission if they had no cluster headache attacks for at least 1 month.
| Participants | Eptinezumab |
|---|---|
| cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks) | 19 |
| Participants | Eptinezumab |
|---|---|
| cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion) | 8 |
| Participants | Eptinezumab |
|---|---|
| cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Second and Third Infusion) | 10 |
| Participants | Eptinezumab |
|---|---|
| cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion) | 9 |
| Participants | Eptinezumab |
|---|---|
| cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion) | 10 |
Transitional treatments were defined as greater occipital nerve (GON) block or oral steroids.
| Participants | Eptinezumab |
|---|---|
| Number of Participants Who Received a Transitional Therapy During the Treatment Period | 17 |
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate better health status.
| score on a scale | Eptinezumab |
|---|---|
| Week 4 | 2.74 ± 0.12 |
| Week 8 | 2.69 ± 0.13 |
| Week 12 | 2.69 ± 0.13 |
| Week 16 | 2.58 ± 0.13 |
| Week 20 | 2.72 ± 0.14 |
| Week 24 | 2.58 ± 0.13 |
| Week 28 | 2.54 ± 0.13 |
| Week 32 | 2.64 ± 0.13 |
| Week 36 | 2.58 ± 0.12 |
| Week 40 | 2.73 ± 0.14 |
| Week 44 | 2.67 ± 0.13 |
| Week 48 | 2.65 ± 0.13 |
The SIS is a patient-reported clinical outcome assessment used to assess quality of life resulting from sleep disturbance. The SIS questionnaire includes 35 items belonging to 7 domains to assess sleep impact on: daily activities; emotional well-being; emotional impact; energy/fatigue; social well-being; mental fatigue; and satisfaction with sleep. Each item, for 6 out of the 7 domains, is rated on a 5-point scale ranging from 1 (always or all of the time) to 5 (never or none of the time), whereas satisfaction with sleep is rated on a 5-point scale ranging from 1 (very satisfied) to 5 (very dissatisfied). Each domain yields a score ranging from 0 to 100, which is presented here. A higher score for Daily Activities, Emotional Well-being, Emotional Impact, Energy/Fatigue, Social Well-being, and Mental Fatigue indicates better quality of life. A lower score for Satisfaction with Sleep indicates a higher quality of life.
| score on a scale | Eptinezumab |
|---|---|
| Daily Activities - Week 4 | 14.98 ± 2.05 |
| Daily Activities - Week 12 | 15.26 ± 2.36 |
| Daily Activities - Week 16 | 16.36 ± 2.48 |
| Daily Activities - Week 24 | 15.54 ± 2.33 |
| Daily Activities - Week 28 | 16.17 ± 2.42 |
| Daily Activities - Week 36 | 14.51 ± 2.39 |
| Daily Activities - Week 40 | 17.83 ± 2.15 |
| Daily Activities - Week 48 | 13.29 ± 2.34 |
| Emotional Well-being - Week 4 | 17.63 ± 2.19 |
| Emotional Well-being - Week 12 | 16.28 ± 2.32 |
| Emotional Well-being - Week 16 | 15.72 ± 2.37 |
| Emotional Well-being - Week 24 | 14.04 ± 2.47 |
| Emotional Well-being - Week 28 | 17.98 ± 2.51 |
| Emotional Well-being - Week 36 | 15.75 ± 2.34 |
| Emotional Well-being - Week 40 | 15.40 ± 2.35 |
| Emotional Well-being - Week 48 | 14.61 ± 2.53 |
| Emotional Impact - Week 4 | 17.41 ± 2.42 |
| Emotional Impact - Week 12 | 17.00 ± 2.48 |
| Emotional Impact - Week 16 | 18.34 ± 2.59 |
| Emotional Impact - Week 24 | 17.01 ± 2.42 |
| Emotional Impact - Week 28 | 20.78 ± 2.53 |
| Emotional Impact - Week 36 | 16.53 ± 2.53 |
| Emotional Impact - Week 40 | 17.21 ± 2.57 |
| Emotional Impact - Week 48 | 15.61 ± 2.58 |
| Energy/Fatigue - Week 4 | 16.00 ± 2.35 |
| Energy/Fatigue - Week 12 | 16.67 ± 2.50 |
| Energy/Fatigue - Week 16 | 16.87 ± 2.63 |
| Energy/Fatigue - Week 24 | 16.59 ± 2.71 |
| Energy/Fatigue - Week 28 | 19.67 ± 2.73 |
| Energy/Fatigue - Week 36 | 15.93 ± 2.62 |
| Energy/Fatigue - Week 40 | 19.16 ± 2.53 |
| Energy/Fatigue - Week 48 | 17.65 ± 2.62 |
| Social Well-being - Week 4 | 14.73 ± 2.06 |
| Social Well-being - Week 12 | 15.28 ± 2.31 |
| Social Well-being - Week 16 | 14.68 ± 2.55 |
| Social Well-being - Week 24 | 14.59 ± 2.46 |
| Social Well-being - Week 28 | 17.30 ± 2.64 |
| Social Well-being - Week 36 | 13.27 ± 2.43 |
| Social Well-being - Week 40 | 15.59 ± 2.42 |
| Social Well-being - Week 48 | 14.13 ± 2.59 |
| Mental Fatigue - Week 4 | 13.00 ± 2.23 |
| Mental Fatigue - Week 12 | 15.00 ± 2.34 |
| Mental Fatigue - Week 16 | 15.15 ± 2.27 |
| Mental Fatigue - Week 24 | 13.57 ± 2.39 |
| Mental Fatigue - Week 28 | 14.86 ± 2.36 |
| Mental Fatigue - Week 36 | 13.64 ± 2.49 |
| Mental Fatigue - Week 40 | 13.98 ± 2.39 |
| Mental Fatigue - Week 48 | 13.55 ± 2.42 |
| Satisfaction With Sleep - Week 4 | -13.86 ± 2.25 |
| Satisfaction With Sleep - Week 12 | -13.47 ± 2.29 |
| Satisfaction With Sleep - Week 16 | -14.50 ± 2.40 |
| Satisfaction With Sleep - Week 24 | -12.30 ± 2.20 |
| Satisfaction With Sleep - Week 28 | -16.67 ± 2.39 |
| Satisfaction With Sleep - Week 36 | -13.95 ± 2.43 |
| Satisfaction With Sleep - Week 40 | -14.99 ± 2.60 |
| Satisfaction With Sleep - Week 48 | -14.19 ± 2.59 |
The EQ-5D-5L is a patient-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). Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems).
| score on a scale | Eptinezumab |
|---|---|
| Mobility - Week 4 | 0.1 ± 0.89 |
| Self Care - Week 4 | 0.0 ± 0.47 |
| Usual Activities - Week 4 | -0.2 ± 1.13 |
| Pain/Discomfort - Week 4 | -0.1 ± 1.28 |
| Anxiety/Depression - Week 4 | -0.1 ± 0.70 |
| Mobility - Week 16 | 0.1 ± 1.02 |
| Self Care - Week 16 | 0.0 ± 0.69 |
| Usual Activities - Week 16 | -0.2 ± 1.07 |
| Pain/Discomfort - Week 16 | -0.2 ± 1.48 |
| Anxiety/Depression - Week 16 | -0.1 ± 0.98 |
| Mobility - Week 28 | 0.1 ± 0.92 |
| Self Care - Week 28 | 0.1 ± 0.65 |
| Usual Activities - Week 28 | -0.1 ± 1.14 |
| Pain/Discomfort - Week 28 | -0.1 ± 1.26 |
| Anxiety/Depression - Week 28 | -0.1 ± 0.98 |
| Mobility - Week 40 | 0.0 ± 0.96 |
| Self Care - Week 40 | 0.0 ± 0.49 |
| Usual Activities - Week 40 | -0.4 ± 1.04 |
| Pain/Discomfort - Week 40 | -0.3 ± 1.42 |
| Anxiety/Depression - Week 40 | -0.1 ± 0.97 |
| Mobility - Week 48 | -0.0 ± 0.90 |
| Self Care - Week 48 | 0.0 ± 0.53 |
| Usual Activities - Week 48 | -0.2 ± 1.17 |
| Pain/Discomfort - Week 48 | -0.1 ± 1.24 |
| Anxiety/Depression - Week 48 | -0.0 ± 1.04 |
The EQ-5D-5L VAS is a participant-reported assessment designed to measure the participant's well-being and ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
| score on a scale | Eptinezumab |
|---|---|
| Week 4 | 9.03 ± 2.07 |
| Week 16 | 9.26 ± 2.30 |
| Week 28 | 6.99 ± 2.39 |
| Week 40 | 8.61 ± 2.11 |
| Week 48 | 6.90 ± 2.31 |
The WPAI:GH2.0 is a patient self-rated clinical outcome assessment designed to provide a quantitative measure of the work productivity and activity impairment due to a health condition. The WPAI:GH2.0 assesses activities over the preceding 7 days and consists of 6 items: 1 item assesses employment (yes/no); 3 items assess the number of hours worked, the number of hours missed from work due to the participant's condition, or due to other reasons; and 2 visual numerical scales assess how much the participant's condition affects his/her productivity at work and his/her ability to complete normal daily activities. Each item (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) was calculated into an impairment percentage ranging from 0 to 100%, with higher numbers indicating greater impairment and less productivity (i.e. worse outcomes). Change from baseline for each item is shown here.
| score on a scale | Eptinezumab |
|---|---|
| Absenteeism - Week 4 | -12.03 ± 2.82 |
| Absenteeism - Week 16 | -8.19 ± 2.98 |
| Absenteeism - Week 28 | -12.73 ± 1.70 |
| Absenteeism - Week 40 | -12.05 ± 2.29 |
| Absenteeism - Week 48 | -5.30 ± 2.99 |
| Presenteeism - Week 4 | -14.29 ± 3.23 |
| Presenteeism - Week 16 | -14.54 ± 3.74 |
| Presenteeism - Week 28 | -11.86 ± 3.78 |
| Presenteeism - Week 40 | -9.88 ± 3.58 |
| Presenteeism - Week 48 | -12.70 ± 3.53 |
| Work productivity loss - Week 4 | -17.28 ± 3.34 |
| Work productivity loss - Week 16 | -16.53 ± 3.98 |
| Work productivity loss - Week 28 | -14.60 ± 3.96 |
| Work productivity loss - Week 40 | -12.50 ± 3.78 |
| Work productivity loss - Week 48 | -12.16 ± 3.77 |
| Activity impairment - Week 4 | -15.99 ± 2.56 |
| Activity impairment - Week 16 | -15.64 ± 2.84 |
| Activity impairment - Week 28 | -17.37 ± 2.74 |
| Activity impairment - Week 40 | -18.73 ± 2.79 |
| Activity impairment - Week 48 | -14.35 ± 2.95 |
Number of participants who visited a family doctor/general practitioner has been reported.
| Participants | Eptinezumab |
|---|---|
| Week 0 - 0 visits | 81 |
| Week 0 - 1 visit | 18 |
| Week 0 - 2 visits | 10 |
| Week 0 - 3 visits | 1 |
| Week 0 - 4 visits | 2 |
| Week 4 - 0 visits | 82 |
| Week 4 - 1 visit | 17 |
| Week 4 - 2 visits | 5 |
| Week 4 - 3 visits | 1 |
| Week 16 - 0 visits | 80 |
| Week 16 - 1 visit | 15 |
| Week 16 - 2 visits | 2 |
| Week 16 - 3 visits | 2 |
| Week 16 - 4 visits | 1 |
| Week 16 - 5 visits | 1 |
| Week 28 - 0 visits | 76 |
| Week 28 - 1 visit | 14 |
| Week 28 - 2 visits | 6 |
| Week 28 - 3 visits | 4 |
| Week 40 - 0 visits | 67 |
| Week 40 - 1 visit | 13 |
| Week 40 - 2 visits | 8 |
| Week 40 - 3 visits | 1 |
| Week 40 - 6 visits | 2 |
| Week 48 - 0 visits | 78 |
| Week 48 - 1 visit | 9 |
| Week 48 - 2 visits | 5 |
| Week 48 - 3 visits | 1 |
| Week 48 - 6 visits | 1 |
Number of participants who visited a specialist has been reported.
| Participants | Eptinezumab |
|---|---|
| Week 0 - 0 visits | 51 |
| Week 0 - 1 visit | 40 |
| Week 0 - 2 visits | 18 |
| Week 0 - 3 visits | 2 |
| Week 0 - 6 visits | 1 |
| Week 4 - 0 visits | 74 |
| Week 4 - 1 visit | 28 |
| Week 4 - 2 visits | 1 |
| Week 4 - 3 visits | 1 |
| Week 4 - 4 visits | 1 |
| Week 16 - 0 visits | 64 |
| Week 16 - 1 visit | 23 |
| Week 16 - 2 visits | 9 |
| Week 16 - 3 visits | 2 |
| Week 16 - 4 visits | 1 |
| Week 16 - 5 visits | 1 |
| Week 16 - 7 visits | 1 |
| Week 28 - 0 visits | 68 |
| Week 28 - 1 visit | 25 |
| Week 28 - 2 visits | 4 |
| Week 28 - 4 visits | 2 |
| Week 28 - 5 visits | 1 |
| Week 40 - 0 visits | 62 |
| Week 40 - 1 visit | 22 |
| Week 40 - 2 visits | 4 |
| Week 40 - 3 visits | 1 |
| Week 40 - 4 visits | 1 |
| Week 40 - 6 visits | 1 |
| Week 48 - 0 visits | 72 |
| Week 48 - 1 visit | 17 |
| Week 48 - 2 visits | 3 |
| Week 48 - 3 visits | 1 |
| Week 48 - 6 visits | 1 |
Number of participants who visited an emergency department due to CH has been reported.
| Participants | Eptinezumab |
|---|---|
| Week 0 - 0 visits | 108 |
| Week 0 - 1 visit | 1 |
| Week 0 - 2 visits | 1 |
| Week 0 - 4 visits | 2 |
| Week 4 - 0 visits | 102 |
| Week 4 - 1 visit | 2 |
| Week 4 - 4 visits | 1 |
| Week 16 - 0 visits | 97 |
| Week 16 - 1 visit | 2 |
| Week 16 - 2 visits | 1 |
| Week 16 - 4 visits | 1 |
| Week 28 - 0 visits | 96 |
| Week 28 - 1 visit | 2 |
| Week 28 - 2 visits | 1 |
| Week 28 - 4 visits | 1 |
| Week 40 - 0 visits | 88 |
| Week 40 - 1 visit | 1 |
| Week 40 - 2 visits | 2 |
| Week 48 - 0 visits | 91 |
| Week 48 - 1 visit | 1 |
| Week 48 - 2 visits | 1 |
| Week 48 - 3 visits | 1 |
Number of participants admitted to the hospital due to CH has been reported.
| Participants | Eptinezumab |
|---|---|
| Week 0 - 0 admissions | 110 |
| Week 0 - 1 admission | 2 |
| Week 4 - 0 admissions | 103 |
| Week 4 - 1 admission | 2 |
| Week 16 - 0 admissions | 98 |
| Week 16 - 1 admission | 2 |
| Week 16 - 5 admissions | 1 |
| Week 28 - 0 admissions | 97 |
| Week 28 - 1 admission | 3 |
| Week 40 - 0 admissions | 89 |
| Week 40 - 1 admission | 1 |
| Week 40 - 5 admissions | 1 |
| Week 48 - 0 admissions | 92 |
| Week 48 - 1 admission | 2 |
Number of participants who had overnight hospital stays due to CH has been reported.
| Participants | Eptinezumab |
|---|---|
| Week 0 - 0 visits | 109 |
| Week 0 - 1 visit | 2 |
| Week 0 - 2 visits | 1 |
| Week 4 - 0 visits | 105 |
| Week 16 - 0 visits | 98 |
| Week 16 - 1 visit | 1 |
| Week 16 - 7 visits | 1 |
| Week 16 - 10 visits | 1 |
| Week 28 - 0 visits | 99 |
| Week 28 - 1 visit | 1 |
| Week 40 - 0 visits | 90 |
| Week 40 - 1 visit | 1 |
| Week 48 - 0 visits | 92 |
| Week 48 - 1 visit | 1 |
| Week 48 - 5 visits | 1 |
Collected over From the day of first dose of study drug (Baseline [Week 0]) up to Week 56. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eptinezumab | 0/131 (0%) | 11/131 (8.4%) | 96/131 (73.3%) |
| Event | Eptinezumab |
|---|---|
| Thyroiditis acuteEndocrine disorders | 1/131 |
| Impaired gastric emptyingGastrointestinal disorders | 1/131 |
| Inguinal herniaGastrointestinal disorders | 1/131 |
| FatigueGeneral disorders | 1/131 |
| Cholecystitis acuteHepatobiliary disorders | 1/131 |
| Jaw fractureInjury, poisoning and procedural complications | 1/131 |
| Weight decreasedInvestigations | 1/131 |
| Back painMusculoskeletal and connective tissue disorders | 1/131 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/131 |
| Cluster headacheNervous system disorders | 1/131 |
| Event | Eptinezumab |
|---|---|
| COVID-19Infections and infestations | 29/131 |
| NasopharyngitisInfections and infestations | 24/131 |
| FatigueGeneral disorders | 22/131 |
| InfluenzaInfections and infestations | 10/131 |
| Back painMusculoskeletal and connective tissue disorders | 9/131 |
| PruritusSkin and subcutaneous tissue disorders | 9/131 |
| NauseaGastrointestinal disorders | 8/131 |
| Weight increasedInvestigations | 8/131 |
| InsomniaPsychiatric disorders | 8/131 |
| VomitingGastrointestinal disorders | 7/131 |
The all-participants-treated set (APTS) included all participants who received infusion with eptinezumab.
| Age, Continuous(years) | Eptinezumab |
|---|---|
| Mean | 45.2 ± 10.79 |
| Sex: Female, Male(Participants) | Eptinezumab |
|---|---|
| Female | 47 |
| Male | 84 |
| Race (NIH/OMB)(Participants) | Eptinezumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 76 |
| More than one race | 4 |
| Unknown or Not Reported | 51 |
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H. Lundbeck A/S