Chronic Cluster Headache
Conditions
Brief summary
The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.
Detailed description
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.
Interventions
DRUGEptinezumab
Eptinezumab will be administered per schedule specified in the arm description.
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The participant has a diagnosis of cCH as defined by International Headache Society (IHS) International Classification of Headache Disorders third edition (ICHD-3) classification with a history of cCH of at least 12 months prior to the Screening Visit. * The participant has a medical history of onset of cluster headache at ≤50 years of age. * The participant has an adequately documented record of previous abortive, transitional and preventive medication use for cCH, for at least 12 months prior to the Screening Visit. * The participant is able to distinguish cluster headache attacks from other headaches (such as tension-type headaches, migraine).
Exclusion criteria
* The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP monoclonal antibodies \[mAbs\] and gepants). * The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, complex regional pain syndrome). * The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache, chronic migraine or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or longer than 1 hour). * Participants with a lifetime history of psychosis, bipolar mania, or dementia. Participants with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to Screening Visit. * The participant has attempted suicide or is, at Screening Visit, at significant risk of suicide. * The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) | From the day of first dose of study drug (Baseline [Week 0]) up to Week 56 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | 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. |
| Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | 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 | 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 | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | The participant completed a CH eDiary, daily, and record for each day/week whether he/she had any CH attacks. |
| Change From Baseline in the Number of Weekly Attacks | Baseline (Week 0), Weeks 1-4 | The average of the estimated change from baseline in the number of weekly attacks across the first 4 weeks after the infusion is shown. |
| Change From Baseline in the Number of Monthly Attacks | Baseline (Week 0), Months 1-12 | The average of the estimated change from baseline in the number of monthly attacks across the first 12 months after the infusion is shown. |
| 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 | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | 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). |
| Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | 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 | 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 | 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) | Week 1 to Week 48 | Participants counted as being in remission if they had no cluster headache attacks for at least 1 month. |
| cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion) | 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) | Week 13 to Week 24 | — |
| 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) | Week 1 to Week 48 | Participants counted as converting from cCH to eCH if they had no CH attacks for at least 3 months. |
| 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) | Week 37 to Week 48 | — |
| Number of Participants Who Received a Transitional Therapy During the Treatment Period | Week 1 to Week 48 | Transitional treatments were defined as greater occipital nerve (GON) block or oral steroids. |
| Patient Global Impression of Change (PGIC) Score | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | 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. |
| Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Baseline (Week 0), Weeks 4, 12, 16, 24, 28, 36, 40, 48 | 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. |
| Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Baseline (Week 0), Weeks 4, 16, 28, 40, 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). |
| Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48 | Baseline (Week 0), Weeks 4, 16, 28, 40, 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). |
| 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 | Baseline (Week 0), Weeks 4, 16, 28, 40, 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. |
| Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Baseline (Week 0), Weeks 4, 16, 28, 40, 48 | Number of participants who visited a family doctor/general practitioner has been reported. |
| Health Care Resource Utilization - Number of Visits to a Specialist | Baseline (Week 0), Weeks 4, 16, 28, 40, 48 | Number of participants who visited a specialist has been reported. |
| Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Baseline (Week 0), Weeks 4, 16, 28, 40, 48 | Number of participants who visited an emergency department due to CH has been reported. |
| Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Baseline (Week 0), Weeks 4, 16, 28, 40, 48 | Number of participants admitted to the hospital due to CH has been reported. |
| Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Baseline (Week 0), Weeks 4, 16, 28, 40, 48 | Number of participants who had overnight hospital stays due to CH has been reported. |
| cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion) | Week 25 to Week 36 | — |
Countries
Denmark, Finland, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eptinezumab Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36. | 131 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lack of Efficacy | 12 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other reasons | 3 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Eptinezumab |
|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 10.79 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 51 Participants |
| Race (NIH/OMB) White | 76 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 131 |
| other Total, other adverse events | 96 / 131 |
| serious Total, serious adverse events | 11 / 131 |
Outcome results
Primary
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
Population: The APTS included all participants who received infusion with eptinezumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eptinezumab | Number of Participants With Treatment-emergent Adverse Events (AEs) | 106 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eptinezumab | cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks) | 19 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Value (COUNT_OF_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 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Value (COUNT_OF_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 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Value (COUNT_OF_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 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_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 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Mobility - Week 4 | 0.1 score on a scale | Standard Deviation 0.89 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Self Care - Week 4 | 0.0 score on a scale | Standard Deviation 0.47 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Usual Activities - Week 4 | -0.2 score on a scale | Standard Deviation 1.13 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Pain/Discomfort - Week 4 | -0.1 score on a scale | Standard Deviation 1.28 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Anxiety/Depression - Week 4 | -0.1 score on a scale | Standard Deviation 0.7 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Mobility - Week 16 | 0.1 score on a scale | Standard Deviation 1.02 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Self Care - Week 16 | 0.0 score on a scale | Standard Deviation 0.69 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Usual Activities - Week 16 | -0.2 score on a scale | Standard Deviation 1.07 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Pain/Discomfort - Week 16 | -0.2 score on a scale | Standard Deviation 1.48 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Anxiety/Depression - Week 16 | -0.1 score on a scale | Standard Deviation 0.98 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Mobility - Week 28 | 0.1 score on a scale | Standard Deviation 0.92 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Self Care - Week 28 | 0.1 score on a scale | Standard Deviation 0.65 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Usual Activities - Week 28 | -0.1 score on a scale | Standard Deviation 1.14 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Pain/Discomfort - Week 28 | -0.1 score on a scale | Standard Deviation 1.26 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Anxiety/Depression - Week 28 | -0.1 score on a scale | Standard Deviation 0.98 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Mobility - Week 40 | 0.0 score on a scale | Standard Deviation 0.96 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Self Care - Week 40 | 0.0 score on a scale | Standard Deviation 0.49 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Usual Activities - Week 40 | -0.4 score on a scale | Standard Deviation 1.04 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Pain/Discomfort - Week 40 | -0.3 score on a scale | Standard Deviation 1.42 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Anxiety/Depression - Week 40 | -0.1 score on a scale | Standard Deviation 0.97 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Mobility - Week 48 | -0.0 score on a scale | Standard Deviation 0.9 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Self Care - Week 48 | 0.0 score on a scale | Standard Deviation 0.53 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Usual Activities - Week 48 | -0.2 score on a scale | Standard Deviation 1.17 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Pain/Discomfort - Week 48 | -0.1 score on a scale | Standard Deviation 1.24 |
| Eptinezumab | Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 | Anxiety/Depression - Week 48 | -0.0 score on a scale | Standard Deviation 1.04 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Impact - Week 24 | 17.01 score on a scale | Standard Deviation 2.42 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Daily Activities - Week 4 | 14.98 score on a scale | Standard Deviation 2.05 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Daily Activities - Week 12 | 15.26 score on a scale | Standard Deviation 2.36 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Daily Activities - Week 16 | 16.36 score on a scale | Standard Deviation 2.48 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Daily Activities - Week 24 | 15.54 score on a scale | Standard Deviation 2.33 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Daily Activities - Week 28 | 16.17 score on a scale | Standard Deviation 2.42 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Daily Activities - Week 36 | 14.51 score on a scale | Standard Deviation 2.39 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Daily Activities - Week 40 | 17.83 score on a scale | Standard Deviation 2.15 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Daily Activities - Week 48 | 13.29 score on a scale | Standard Deviation 2.34 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Well-being - Week 4 | 17.63 score on a scale | Standard Deviation 2.19 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Well-being - Week 12 | 16.28 score on a scale | Standard Deviation 2.32 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Well-being - Week 16 | 15.72 score on a scale | Standard Deviation 2.37 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Well-being - Week 24 | 14.04 score on a scale | Standard Deviation 2.47 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Well-being - Week 28 | 17.98 score on a scale | Standard Deviation 2.51 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Well-being - Week 36 | 15.75 score on a scale | Standard Deviation 2.34 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Well-being - Week 40 | 15.40 score on a scale | Standard Deviation 2.35 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Well-being - Week 48 | 14.61 score on a scale | Standard Deviation 2.53 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Impact - Week 4 | 17.41 score on a scale | Standard Deviation 2.42 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Impact - Week 12 | 17.00 score on a scale | Standard Deviation 2.48 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Impact - Week 16 | 18.34 score on a scale | Standard Deviation 2.59 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Impact - Week 28 | 20.78 score on a scale | Standard Deviation 2.53 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Impact - Week 36 | 16.53 score on a scale | Standard Deviation 2.53 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Impact - Week 40 | 17.21 score on a scale | Standard Deviation 2.57 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Emotional Impact - Week 48 | 15.61 score on a scale | Standard Deviation 2.58 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Energy/Fatigue - Week 4 | 16.00 score on a scale | Standard Deviation 2.35 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Energy/Fatigue - Week 12 | 16.67 score on a scale | Standard Deviation 2.5 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Energy/Fatigue - Week 16 | 16.87 score on a scale | Standard Deviation 2.63 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Energy/Fatigue - Week 24 | 16.59 score on a scale | Standard Deviation 2.71 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Energy/Fatigue - Week 28 | 19.67 score on a scale | Standard Deviation 2.73 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Energy/Fatigue - Week 36 | 15.93 score on a scale | Standard Deviation 2.62 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Energy/Fatigue - Week 40 | 19.16 score on a scale | Standard Deviation 2.53 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Energy/Fatigue - Week 48 | 17.65 score on a scale | Standard Deviation 2.62 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Social Well-being - Week 4 | 14.73 score on a scale | Standard Deviation 2.06 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Social Well-being - Week 12 | 15.28 score on a scale | Standard Deviation 2.31 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Social Well-being - Week 16 | 14.68 score on a scale | Standard Deviation 2.55 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Social Well-being - Week 24 | 14.59 score on a scale | Standard Deviation 2.46 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Social Well-being - Week 28 | 17.30 score on a scale | Standard Deviation 2.64 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Social Well-being - Week 36 | 13.27 score on a scale | Standard Deviation 2.43 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Social Well-being - Week 40 | 15.59 score on a scale | Standard Deviation 2.42 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Social Well-being - Week 48 | 14.13 score on a scale | Standard Deviation 2.59 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Mental Fatigue - Week 4 | 13.00 score on a scale | Standard Deviation 2.23 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Mental Fatigue - Week 12 | 15.00 score on a scale | Standard Deviation 2.34 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Mental Fatigue - Week 16 | 15.15 score on a scale | Standard Deviation 2.27 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Mental Fatigue - Week 24 | 13.57 score on a scale | Standard Deviation 2.39 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Mental Fatigue - Week 28 | 14.86 score on a scale | Standard Deviation 2.36 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Mental Fatigue - Week 36 | 13.64 score on a scale | Standard Deviation 2.49 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Mental Fatigue - Week 40 | 13.98 score on a scale | Standard Deviation 2.39 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Mental Fatigue - Week 48 | 13.55 score on a scale | Standard Deviation 2.42 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Satisfaction With Sleep - Week 4 | -13.86 score on a scale | Standard Deviation 2.25 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Satisfaction With Sleep - Week 12 | -13.47 score on a scale | Standard Deviation 2.29 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Satisfaction With Sleep - Week 16 | -14.50 score on a scale | Standard Deviation 2.4 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Satisfaction With Sleep - Week 24 | -12.30 score on a scale | Standard Deviation 2.2 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Satisfaction With Sleep - Week 28 | -16.67 score on a scale | Standard Deviation 2.39 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Satisfaction With Sleep - Week 36 | -13.95 score on a scale | Standard Deviation 2.43 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Satisfaction With Sleep - Week 40 | -14.99 score on a scale | Standard Deviation 2.6 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time | Satisfaction With Sleep - Week 48 | -14.19 score on a scale | Standard Deviation 2.59 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | 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 | Week 1 | -0.47 score on a scale | Standard Error 0.06 |
| Eptinezumab | 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 | Week 2 | -0.51 score on a scale | Standard Error 0.07 |
| Eptinezumab | 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 | Week 3 | -0.58 score on a scale | Standard Error 0.07 |
| Eptinezumab | 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 | Week 4 | -0.59 score on a scale | Standard Error 0.08 |
| Eptinezumab | 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 | Week 13 | -0.78 score on a scale | Standard Error 0.09 |
| Eptinezumab | 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 | Week 14 | -0.75 score on a scale | Standard Error 0.09 |
| Eptinezumab | 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 | Week 15 | -0.82 score on a scale | Standard Error 0.08 |
| Eptinezumab | 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 | Week 16 | -0.90 score on a scale | Standard Error 0.09 |
| Eptinezumab | 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 | Week 25 | -0.80 score on a scale | Standard Error 0.09 |
| Eptinezumab | 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 | Week 26 | -0.79 score on a scale | Standard Error 0.09 |
| Eptinezumab | 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 | Week 27 | -0.88 score on a scale | Standard Error 0.09 |
| Eptinezumab | 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 | Week 28 | -0.84 score on a scale | Standard Error 0.09 |
| Eptinezumab | 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 | Week 37 | -0.77 score on a scale | Standard Error 0.09 |
| Eptinezumab | 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 | Week 38 | -0.79 score on a scale | Standard Error 0.1 |
| Eptinezumab | 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 | Week 39 | -0.70 score on a scale | Standard Error 0.1 |
| Eptinezumab | 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 | Week 40 | -0.79 score on a scale | Standard Error 0.1 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 1 | -3.00 Attacks per week | Standard Error 0.54 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 2 | -3.92 Attacks per week | Standard Error 0.79 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 3 | -4.51 Attacks per week | Standard Error 0.93 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 4 | -4.98 Attacks per week | Standard Error 1.18 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 13 | -6.18 Attacks per week | Standard Error 1.2 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 14 | -6.31 Attacks per week | Standard Error 1.15 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 15 | -5.81 Attacks per week | Standard Error 1.08 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 16 | -6.63 Attacks per week | Standard Error 1.24 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 25 | -5.56 Attacks per week | Standard Error 1.26 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 26 | -5.95 Attacks per week | Standard Error 1.27 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 27 | -7.09 Attacks per week | Standard Error 1.22 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 28 | -6.51 Attacks per week | Standard Error 1.31 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 37 | -6.25 Attacks per week | Standard Error 1.27 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 38 | -6.57 Attacks per week | Standard Error 1.14 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 39 | -5.99 Attacks per week | Standard Error 1.23 |
| Eptinezumab | Change From Baseline in the Average Number of Weekly Attacks | Week 40 | -6.39 Attacks per week | Standard Error 1.15 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48 | Week 4 | 9.03 score on a scale | Standard Error 2.07 |
| Eptinezumab | Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48 | Week 16 | 9.26 score on a scale | Standard Error 2.3 |
| Eptinezumab | Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48 | Week 28 | 6.99 score on a scale | Standard Error 2.39 |
| Eptinezumab | Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48 | Week 40 | 8.61 score on a scale | Standard Error 2.11 |
| Eptinezumab | Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48 | Week 48 | 6.90 score on a scale | Standard Error 2.31 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Eptinezumab | Change From Baseline in the Number of Monthly Attacks | -22.65 Attacks per month | Standard Error 4.39 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Eptinezumab | Change From Baseline in the Number of Weekly Attacks | -3.46 Attacks per week | Standard Error 0.61 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Eptinezumab | Change From Baseline in the Number of Weekly Attacks | -4.11 Attacks per week | Standard Error 0.79 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | 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 | Activity impairment - Week 16 | -15.64 score on a scale | Standard Deviation 2.84 |
| Eptinezumab | 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 | Activity impairment - Week 28 | -17.37 score on a scale | Standard Deviation 2.74 |
| Eptinezumab | 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 | Absenteeism - Week 4 | -12.03 score on a scale | Standard Deviation 2.82 |
| Eptinezumab | 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 | Absenteeism - Week 16 | -8.19 score on a scale | Standard Deviation 2.98 |
| Eptinezumab | 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 | Absenteeism - Week 28 | -12.73 score on a scale | Standard Deviation 1.7 |
| Eptinezumab | 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 | Absenteeism - Week 40 | -12.05 score on a scale | Standard Deviation 2.29 |
| Eptinezumab | 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 | Absenteeism - Week 48 | -5.30 score on a scale | Standard Deviation 2.99 |
| Eptinezumab | 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 | Presenteeism - Week 4 | -14.29 score on a scale | Standard Deviation 3.23 |
| Eptinezumab | 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 | Presenteeism - Week 16 | -14.54 score on a scale | Standard Deviation 3.74 |
| Eptinezumab | 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 | Presenteeism - Week 28 | -11.86 score on a scale | Standard Deviation 3.78 |
| Eptinezumab | 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 | Presenteeism - Week 40 | -9.88 score on a scale | Standard Deviation 3.58 |
| Eptinezumab | 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 | Presenteeism - Week 48 | -12.70 score on a scale | Standard Deviation 3.53 |
| Eptinezumab | 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 | Work productivity loss - Week 4 | -17.28 score on a scale | Standard Deviation 3.34 |
| Eptinezumab | 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 | Work productivity loss - Week 16 | -16.53 score on a scale | Standard Deviation 3.98 |
| Eptinezumab | 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 | Work productivity loss - Week 28 | -14.60 score on a scale | Standard Deviation 3.96 |
| Eptinezumab | 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 | Work productivity loss - Week 40 | -12.50 score on a scale | Standard Deviation 3.78 |
| Eptinezumab | 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 | Work productivity loss - Week 48 | -12.16 score on a scale | Standard Deviation 3.77 |
| Eptinezumab | 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 | Activity impairment - Week 4 | -15.99 score on a scale | Standard Deviation 2.56 |
| Eptinezumab | 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 | Activity impairment - Week 40 | -18.73 score on a scale | Standard Deviation 2.79 |
| Eptinezumab | 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 | Activity impairment - Week 48 | -14.35 score on a scale | Standard Deviation 2.95 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 1 | -3.63 Abortive therapy use per week | Standard Error 0.53 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 2 | -4.24 Abortive therapy use per week | Standard Error 0.7 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 3 | -4.90 Abortive therapy use per week | Standard Error 0.76 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 4 | -4.99 Abortive therapy use per week | Standard Error 0.94 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 13 | -7.22 Abortive therapy use per week | Standard Error 0.84 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 14 | -6.83 Abortive therapy use per week | Standard Error 0.85 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 15 | -6.06 Abortive therapy use per week | Standard Error 0.84 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 16 | -6.42 Abortive therapy use per week | Standard Error 0.96 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 25 | -6.18 Abortive therapy use per week | Standard Error 0.99 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 26 | -6.56 Abortive therapy use per week | Standard Error 0.86 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 27 | -7.56 Abortive therapy use per week | Standard Error 0.82 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 28 | -7.12 Abortive therapy use per week | Standard Error 0.83 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 37 | -6.55 Abortive therapy use per week | Standard Error 0.98 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 38 | -6.97 Abortive therapy use per week | Standard Error 0.84 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 39 | -6.71 Abortive therapy use per week | Standard Error 1.04 |
| Eptinezumab | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Week 40 | -7.09 Abortive therapy use per week | Standard Error 0.84 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 1 | -1.72 Oxygen use per week | Standard Error 0.33 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 2 | -2.43 Oxygen use per week | Standard Error 0.4 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 3 | -3.17 Oxygen use per week | Standard Error 0.48 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 4 | -3.23 Oxygen use per week | Standard Error 0.59 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 13 | -3.97 Oxygen use per week | Standard Error 0.57 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 14 | -3.93 Oxygen use per week | Standard Error 0.56 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 15 | -3.09 Oxygen use per week | Standard Error 0.53 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 16 | -3.78 Oxygen use per week | Standard Error 0.61 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 25 | -3.56 Oxygen use per week | Standard Error 0.67 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 26 | -3.75 Oxygen use per week | Standard Error 0.58 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 27 | -4.06 Oxygen use per week | Standard Error 0.52 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 28 | -4.02 Oxygen use per week | Standard Error 0.54 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 37 | -3.60 Oxygen use per week | Standard Error 0.64 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 38 | -3.74 Oxygen use per week | Standard Error 0.52 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 39 | -3.99 Oxygen use per week | Standard Error 0.66 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Week 40 | -3.82 Oxygen use per week | Standard Error 0.55 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 1 | -1.75 Triptans use per week | Standard Error 0.33 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 2 | -1.73 Triptans use per week | Standard Error 0.42 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 3 | -1.74 Triptans use per week | Standard Error 0.44 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 4 | -1.90 Triptans use per week | Standard Error 0.45 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 13 | -2.94 Triptans use per week | Standard Error 0.46 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 14 | -2.78 Triptans use per week | Standard Error 0.5 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 15 | -2.81 Triptans use per week | Standard Error 0.49 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 16 | -2.50 Triptans use per week | Standard Error 0.51 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 25 | -2.05 Triptans use per week | Standard Error 0.52 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 26 | -2.48 Triptans use per week | Standard Error 0.48 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 27 | -3.06 Triptans use per week | Standard Error 0.45 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 28 | -2.86 Triptans use per week | Standard Error 0.46 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 37 | -2.55 Triptans use per week | Standard Error 0.5 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 38 | -2.54 Triptans use per week | Standard Error 0.49 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 39 | -2.52 Triptans use per week | Standard Error 0.58 |
| Eptinezumab | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Week 40 | -2.95 Triptans use per week | Standard Error 0.54 |
Secondary
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
Population: The Full Analysis Set (FAS) included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
| Arm | Measure | Value (COUNT_OF_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 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 4 - 4 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 16 - 0 visits | 97 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 16 - 1 visit | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 16 - 2 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 16 - 4 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 28 - 0 visits | 96 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 0 - 0 visits | 108 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 0 - 1 visit | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 0 - 2 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 0 - 4 visits | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 4 - 0 visits | 102 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 4 - 1 visit | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 28 - 1 visit | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 28 - 2 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 28 - 4 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 40 - 0 visits | 88 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 40 - 1 visit | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 40 - 2 visits | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 48 - 0 visits | 91 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 48 - 1 visit | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 48 - 2 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache | Week 48 - 3 visits | 1 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 0 - 0 admissions | 110 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 0 - 1 admission | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 4 - 0 admissions | 103 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 4 - 1 admission | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 16 - 0 admissions | 98 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 16 - 1 admission | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 16 - 5 admissions | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 28 - 0 admissions | 97 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 28 - 1 admission | 3 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 40 - 0 admissions | 89 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 40 - 1 admission | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 40 - 5 admissions | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 48 - 0 admissions | 92 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache | Week 48 - 1 admission | 2 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 48 - 2 visits | 5 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 48 - 3 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 0 - 0 visits | 81 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 0 - 1 visit | 18 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 0 - 2 visits | 10 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 0 - 3 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 0 - 4 visits | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 4 - 0 visits | 82 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 4 - 1 visit | 17 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 4 - 2 visits | 5 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 4 - 3 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 16 - 0 visits | 80 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 16 - 1 visit | 15 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 16 - 2 visits | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 16 - 3 visits | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 16 - 4 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 16 - 5 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 28 - 0 visits | 76 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 28 - 1 visit | 14 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 28 - 2 visits | 6 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 28 - 3 visits | 4 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 40 - 0 visits | 67 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 40 - 1 visit | 13 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 40 - 2 visits | 8 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 40 - 3 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 40 - 6 visits | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 48 - 0 visits | 78 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 48 - 1 visit | 9 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner | Week 48 - 6 visits | 1 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 0 - 0 visits | 51 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 0 - 1 visit | 40 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 0 - 2 visits | 18 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 0 - 3 visits | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 0 - 6 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 4 - 0 visits | 74 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 4 - 1 visit | 28 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 4 - 2 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 4 - 3 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 4 - 4 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 16 - 0 visits | 64 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 16 - 1 visit | 23 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 16 - 2 visits | 9 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 16 - 3 visits | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 16 - 4 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 16 - 5 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 16 - 7 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 28 - 0 visits | 68 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 28 - 1 visit | 25 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 28 - 2 visits | 4 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 28 - 4 visits | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 28 - 5 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 40 - 0 visits | 62 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 40 - 1 visit | 22 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 40 - 2 visits | 4 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 40 - 3 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 40 - 4 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 40 - 6 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 48 - 0 visits | 72 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 48 - 1 visit | 17 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 48 - 2 visits | 3 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 48 - 3 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Number of Visits to a Specialist | Week 48 - 6 visits | 1 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 40 - 0 visits | 90 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 0 - 0 visits | 109 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 0 - 1 visit | 2 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 0 - 2 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 4 - 0 visits | 105 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 16 - 0 visits | 98 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 16 - 1 visit | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 16 - 7 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 16 - 10 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 28 - 0 visits | 99 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 28 - 1 visit | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 40 - 1 visit | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 48 - 0 visits | 92 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 48 - 1 visit | 1 Participants |
| Eptinezumab | Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache | Week 48 - 5 visits | 1 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eptinezumab | Number of Participants Who Received a Transitional Therapy During the Treatment Period | 17 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 4 | 2.74 score on a scale | Standard Error 0.12 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 8 | 2.69 score on a scale | Standard Error 0.13 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 12 | 2.69 score on a scale | Standard Error 0.13 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 16 | 2.58 score on a scale | Standard Error 0.13 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 20 | 2.72 score on a scale | Standard Error 0.14 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 24 | 2.58 score on a scale | Standard Error 0.13 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 28 | 2.54 score on a scale | Standard Error 0.13 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 32 | 2.64 score on a scale | Standard Error 0.13 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 36 | 2.58 score on a scale | Standard Error 0.12 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 40 | 2.73 score on a scale | Standard Error 0.14 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 44 | 2.67 score on a scale | Standard Error 0.13 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score | Week 48 | 2.65 score on a scale | Standard Error 0.13 |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 1 | 49 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 2 | 52 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 3 | 55 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 4 | 55 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 13 | 54 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 14 | 63 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 15 | 58 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 16 | 62 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 25 | 60 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 26 | 60 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 27 | 62 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 28 | 48 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 37 | 57 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 38 | 51 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 39 | 43 Participants |
| Eptinezumab | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Week 40 | 44 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 1 | 30 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 2 | 36 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 3 | 42 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 4 | 40 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 13 | 35 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 14 | 45 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 15 | 43 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 16 | 48 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 25 | 43 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 26 | 45 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 27 | 45 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 28 | 39 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 37 | 40 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 38 | 41 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 39 | 34 Participants |
| Eptinezumab | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Week 40 | 38 Participants |
Secondary
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
Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 1 | 11 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 2 | 13 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 3 | 21 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 4 | 20 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 13 | 23 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 14 | 25 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 15 | 23 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 16 | 29 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 25 | 29 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 26 | 24 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 27 | 28 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 28 | 24 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 37 | 27 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 38 | 28 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 39 | 21 Participants |
| Eptinezumab | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Week 40 | 25 Participants |