Cluster Headache, Episodic
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)
Detailed description
Eligible participants will be randomly assigned to receive treatment, in a blinded manner, two infusions of either eptinezumab or placebo in a cross-over manner during the Placebo-controlled Period and Active Treatment Period of the study. The total duration of the study after randomization is 24 weeks, including a safety follow-up period of 8 weeks.
Interventions
DRUGPlacebo
Placebo - 100 milliliters (mL) of 0.9% normal saline, intravenously
DRUGEptinezumab
Eptinezumab - concentrate for solution for infusion, intravenously
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The participant has episodic cluster headache, as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) classification, with an adequately documented record or reliable history of eCH of at least 12 months prior to Screening Visit 1. * The participant has a prior history of cluster period(s) lasting 6 weeks or longer, when untreated. * The participant is able to distinguish cluster headache attacks from other headaches (that is; tension-type headaches, migraine). * The participant is, at Screening Visit 2, in cluster headache bout, characterized by the presence of at least one typical cluster headache attack, that started not later than 1 week prior to Screening Visit 2. * The participant has a medical history of first symptoms of cluster headache from ≤60 years of age.
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 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 brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). * Participants with a lifetime history of psychosis, bipolar mania, or dementia are excluded. 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 2 are also excluded. * The participant is, at Screening Visit 2, at significant risk of suicide. * The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | The participant completed a CH eDiary, daily, and recorded for each day/week whether he/she had any CH attacks. For each CH attack, the start date and time was collected. The participant recorded further daily information regarding CH characteristics and intake of acute medication for CH. CH items were assessed with a yes/no response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | — |
| Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | Abortive medications included the use of triptans or oxygen (O2). |
| Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3 | Baseline (Week 0), Days 1-3 | — |
| Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | — |
| Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks | From first infusion (Baseline, Day 0) to 4 weeks | Presented here is the result of the analysis of time from first infusion of IMP to resolution of cluster headache bout. The hazard ratio estimate is an estimate from the Cox model of time to resolution. |
| Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP | From first infusion in the placebo-controlled period (Baseline, Day 0) to 24-hours after the first infusion in the placebo-controlled period | — |
| Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3 | Baseline (Week 0), Days 1-3 | The severity of pain 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). |
| Change From Baseline to Week 1 in the Number of Weekly Attacks | Baseline (Week 0), Week 1 | — |
| Change From Baseline to Week 2 in the Number of Weekly Attacks | Baseline (Week 0), Week 2 | — |
| Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1 | Baseline (Week 0), Week 1 | — |
| Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1 | Baseline (Week 0), Week 1 | — |
| Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | — |
| Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes. |
| HCRU Score: Number of Visits to a Specialist | Week 4 | Number of participants who visited a specialist has been reported. |
| Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain | Baseline (Week 0), Week 1 | The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes. |
| Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain | Baseline (Week 0), Week 2 | The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes. |
| Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4 | Baseline (Week 0), Weeks 1-4 | — |
| Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4 | Baseline (Week 0), Weeks 1-4 | The weekly integrated measure of frequency and intensity of pain score calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes. |
| Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | Baseline (Week 0), Weeks 1, 2, 3, and 4 | 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). |
| Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4 | Baseline (Week 0), Weeks 3-4 | — |
| Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4 | Weeks 1, 2, and 4 | 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 at Weeks 2 and 4 | Baseline (Week 0), Weeks 2 and 4 | 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-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4 | Baseline (Week 0), Weeks 2 and 4 | 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). |
| HCRU Score: Number of Emergency Department Visits Due to Cluster Headache | Week 4 | Number of participants who visited an emergency department due to CH was reported. |
| HCRU Score: Number of Hospital Admissions Due to Cluster Headache | Week 4 | Number of participants who were admitted to a hospital due to CH was reported. |
| HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache | Week 4 | Number of participants who stayed overnight in a hospital due to CH was reported. |
| Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 | Baseline (Week 0), Week 4 | 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 (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | Week 4 | Number of participants who visited a family doctor/general practitioner has been reported. |
Countries
Belgium, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Italy, Japan, Netherlands, Norway, Portugal, Russia, Spain, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eptinezumab Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution. | 113 |
| Placebo Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab. | 118 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Delayed Start Period | Adverse Event | 0 | 0 | 1 | 0 |
| Delayed Start Period | Lack of Efficacy | 0 | 0 | 0 | 3 |
| Delayed Start Period | Lost to Follow-up | 0 | 0 | 2 | 1 |
| Delayed Start Period | other reasons | 0 | 0 | 1 | 0 |
| Delayed Start Period | Withdrawal by Subject | 0 | 0 | 2 | 4 |
| Placebo-controlled Period | Adverse Event | 2 | 0 | 0 | 0 |
| Placebo-controlled Period | Lack of Efficacy | 1 | 2 | 0 | 0 |
| Placebo-controlled Period | Other reasons | 0 | 1 | 0 | 0 |
| Placebo-controlled Period | Protocol Violation | 0 | 1 | 0 | 0 |
| Placebo-controlled Period | Randomized, not treated | 1 | 1 | 0 | 0 |
| Placebo-controlled Period | Withdrawal by Subject | 1 | 6 | 0 | 0 |
Baseline characteristics
| Characteristic | Eptinezumab | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 44.17 years STANDARD_DEVIATION 11.099 | 43.94 years STANDARD_DEVIATION 11.019 | 44.05 years STANDARD_DEVIATION 11.035 |
| Number of Weekly Cluster Headache (CH) Attacks | 15.2 Number of Weekly Attacks STANDARD_DEVIATION 8.07 | 15.7 Number of Weekly Attacks STANDARD_DEVIATION 8.28 | 15.4 Number of Weekly Attacks STANDARD_DEVIATION 8.17 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized White | 97 Participants | 103 Participants | 200 Participants |
| Sex: Female, Male Female | 27 Participants | 24 Participants | 51 Participants |
| Sex: Female, Male Male | 85 Participants | 93 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 117 | 0 / 108 | 0 / 107 |
| other Total, other adverse events | 10 / 112 | 9 / 117 | 13 / 108 | 9 / 107 |
| serious Total, serious adverse events | 2 / 112 | 0 / 117 | 2 / 108 | 1 / 107 |
Outcome results
Primary
Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2
The participant completed a CH eDiary, daily, and recorded for each day/week whether he/she had any CH attacks. For each CH attack, the start date and time was collected. The participant recorded further daily information regarding CH characteristics and intake of acute medication for CH. CH items were assessed with a yes/no response.
Time frame: Baseline (Week 0), Weeks 1-2
Population: The APRS included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Eptinezumab | Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2 | -4.0 Number of Weekly Attacks | Standard Error 0.93 |
| Placebo | Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2 | -4.6 Number of Weekly Attacks | Standard Error 0.89 |
Comparison: Change From Baseline in the Number of Weekly Attacks: Eptinezumab vs. Placebop-value: 0.504895% CI: [-1.3, 2.6]Mixed Models Repeated Measures
Secondary
Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4
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 2 and 4
Population: The APRS included all randomized participants. 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 the specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4 | Week 2 | 8.21 score on a scale | Standard Error 2.79 |
| Eptinezumab | Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4 | Week 4 | 13.49 score on a scale | Standard Error 2.8 |
| Placebo | Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4 | Week 2 | 3.47 score on a scale | Standard Error 2.86 |
| Placebo | Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4 | Week 4 | 5.73 score on a scale | Standard Error 2.77 |
Secondary
Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP
Time frame: From first infusion in the placebo-controlled period (Baseline, Day 0) to 24-hours after the first infusion in the placebo-controlled period
Population: The APRS included all randomized participants. 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 Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP | 2.07 Number of attacks | Standard Error 0.18 |
| Placebo | Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP | 1.96 Number of attacks | Standard Error 0.17 |
Secondary
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
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 2 and 4
Population: The APRS included all randomized participants. 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 the specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Daily Activities - Week 2 | 16.83 score on a scale | Standard Error 3.08 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Daily Activities - Week 4 | 24.82 score on a scale | Standard Error 3.19 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Emotional Well-being - Week 2 | 14.85 score on a scale | Standard Error 2.84 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Emotional Well-being - Week 4 | 22.77 score on a scale | Standard Error 3.07 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Energy/Fatigue - Week 2 | 18.16 score on a scale | Standard Error 3.23 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Energy/Fatigue - Week 4 | 24.16 score on a scale | Standard Error 3.47 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Mental Fatigue - Week 2 | 9.04 score on a scale | Standard Error 2.66 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Mental Fatigue - Week 4 | 15.15 score on a scale | Standard Error 2.91 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Emotional Impact - Week 2 | 14.39 score on a scale | Standard Error 3.02 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Emotional Impact - Week 4 | 23.09 score on a scale | Standard Error 3.29 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Social Well-being - Week 2 | 15.22 score on a scale | Standard Error 3.37 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Social Well-being - Week 4 | 23.74 score on a scale | Standard Error 3.46 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Satisfaction with Sleep - Week 2 | -11.41 score on a scale | Standard Error 2.75 |
| Eptinezumab | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Satisfaction with Sleep - Week 4 | -19.60 score on a scale | Standard Error 2.88 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Social Well-being - Week 2 | 6.92 score on a scale | Standard Error 3.35 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Daily Activities - Week 2 | 8.93 score on a scale | Standard Error 3.06 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Mental Fatigue - Week 4 | 8.00 score on a scale | Standard Error 2.81 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Daily Activities - Week 4 | 13.97 score on a scale | Standard Error 3.08 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Satisfaction with Sleep - Week 2 | -6.06 score on a scale | Standard Error 2.73 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Emotional Well-being - Week 2 | 6.04 score on a scale | Standard Error 2.81 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Emotional Impact - Week 2 | 6.00 score on a scale | Standard Error 3 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Emotional Well-being - Week 4 | 12.22 score on a scale | Standard Error 2.97 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Social Well-being - Week 4 | 13.91 score on a scale | Standard Error 3.35 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Energy/Fatigue - Week 2 | 8.03 score on a scale | Standard Error 3.19 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Emotional Impact - Week 4 | 13.36 score on a scale | Standard Error 3.18 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Energy/Fatigue - Week 4 | 14.68 score on a scale | Standard Error 3.36 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Satisfaction with Sleep - Week 4 | -9.63 score on a scale | Standard Error 2.78 |
| Placebo | Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | Mental Fatigue - Week 2 | 4.15 score on a scale | Standard Error 2.64 |
Secondary
Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3
The severity of pain 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), Days 1-3
Population: The APRS included all randomized participants. 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 Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3 | -0.30 score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3 | -0.18 score on a scale | Standard Error 0.09 |
Secondary
Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4
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, and 4
Population: The APRS included all randomized participants. 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 the specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | Week 1 | -0.33 score on a scale | Standard Error 0.09 |
| Eptinezumab | Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | Week 2 | -0.46 score on a scale | Standard Error 0.1 |
| Eptinezumab | Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | Week 3 | -0.56 score on a scale | Standard Error 0.11 |
| Eptinezumab | Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | Week 4 | -0.51 score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | Week 4 | -0.42 score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | Week 1 | -0.24 score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | Week 3 | -0.31 score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | Week 2 | -0.35 score on a scale | Standard Error 0.09 |
Secondary
Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3
Time frame: Baseline (Week 0), Days 1-3
Population: The APRS included all randomized participants. 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 Daily Attacks, Averaged Over Days 1-3 | -0.22 Attacks per day | Standard Error 0.16 |
| Placebo | Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3 | -0.35 Attacks per day | Standard Error 0.15 |
Secondary
Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2
Time frame: Baseline (Week 0), Weeks 1-2
Population: The APRS included all randomized participants. 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 Days With <3 Attacks Per Day, Averaged Over Weeks 1-2 | 0.60 Days | Standard Error 0.2 |
| Placebo | Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2 | 0.82 Days | Standard Error 0.19 |
Secondary
Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4
Time frame: Baseline (Week 0), Weeks 1-4
Population: The APRS included all randomized participants. 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, Averaged Over Weeks 1-4 | -5.95 Attacks per week | Standard Error 0.92 |
| Placebo | Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4 | -5.78 Attacks per week | Standard Error 0.88 |
Secondary
Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4
Time frame: Baseline (Week 0), Weeks 3-4
Population: The APRS included all randomized participants. 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 the specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4 | Week 3 | -7.35 Attacks per week | Standard Error 0.98 |
| Eptinezumab | Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4 | Week 4 | -8.37 Attacks per week | Standard Error 1.11 |
| Placebo | Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4 | Week 3 | -6.60 Attacks per week | Standard Error 0.94 |
| Placebo | Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4 | Week 4 | -7.15 Attacks per week | Standard Error 1.07 |
Secondary
Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2
Abortive medications included the use of triptans or oxygen (O2).
Time frame: Baseline (Week 0), Weeks 1-2
Population: The APRS included all randomized participants. 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 Times an Abortive Medication Was Used, Averaged Over Weeks 1-2 | -2.54 Abortive therapy use per week | Standard Error 0.98 |
| Placebo | Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2 | -3.55 Abortive therapy use per week | Standard Error 0.93 |
Secondary
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4
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), Week 4
Population: The APRS included all randomized participants. 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 (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 | Absenteeism | -13.71 score on a scale | Standard Error 3.95 |
| Eptinezumab | Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 | Presenteeism | -19.29 score on a scale | Standard Error 4.81 |
| Eptinezumab | Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 | Work productivity loss | -23.59 score on a scale | Standard Error 5.34 |
| Eptinezumab | Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 | Activity impairment | -25.84 score on a scale | Standard Error 3.7 |
| Placebo | Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 | Activity impairment | -15.82 score on a scale | Standard Error 3.58 |
| Placebo | Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 | Absenteeism | -4.37 score on a scale | Standard Error 3.74 |
| Placebo | Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 | Work productivity loss | -13.68 score on a scale | Standard Error 5.2 |
| Placebo | Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 | Presenteeism | -11.03 score on a scale | Standard Error 4.68 |
Secondary
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2
The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
Time frame: Baseline (Week 0), Weeks 1-2
Population: The APRS included all randomized participants. 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 Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2 | -13.39 score on a scale | Standard Error 2.56 |
| Placebo | Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2 | -14.46 score on a scale | Standard Error 2.43 |
Secondary
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4
The weekly integrated measure of frequency and intensity of pain score calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
Time frame: Baseline (Week 0), Weeks 1-4
Population: The APRS included all randomized participants. 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 Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4 | -17.81 score on a scale | Standard Error 2.5 |
| Placebo | Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4 | -16.81 score on a scale | Standard Error 2.37 |
Secondary
Change From Baseline to Week 1 in the Number of Weekly Attacks
Time frame: Baseline (Week 0), Week 1
Population: The APRS included all randomized participants. 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 to Week 1 in the Number of Weekly Attacks | -2.62 Attacks per week | Standard Error 0.95 |
| Placebo | Change From Baseline to Week 1 in the Number of Weekly Attacks | -3.71 Attacks per week | Standard Error 0.9 |
Secondary
Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain
The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
Time frame: Baseline (Week 0), Week 1
Population: The APRS included all randomized participants. 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 to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain | -10.58 score on a scale | Standard Error 2.55 |
| Placebo | Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain | -11.96 score on a scale | Standard Error 2.42 |
Secondary
Change From Baseline to Week 2 in the Number of Weekly Attacks
Time frame: Baseline (Week 0), Week 2
Population: The APRS included all randomized participants. 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 to Week 2 in the Number of Weekly Attacks | -5.44 Attacks per week | Standard Error 1 |
| Placebo | Change From Baseline to Week 2 in the Number of Weekly Attacks | -5.64 Attacks per week | Standard Error 0.96 |
Secondary
Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain
The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
Time frame: Baseline (Week 0), Week 2
Population: The APRS included all randomized participants. 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 to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain | -16.20 score on a scale | Standard Error 2.73 |
| Placebo | Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain | -16.95 score on a scale | Standard Error 2.61 |
Secondary
HCRU Score: Number of Emergency Department Visits Due to Cluster Headache
Number of participants who visited an emergency department due to CH was reported.
Time frame: Week 4
Population: The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure at the specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | HCRU Score: Number of Emergency Department Visits Due to Cluster Headache | 0 visits | 98 Participants |
| Eptinezumab | HCRU Score: Number of Emergency Department Visits Due to Cluster Headache | 1 visit | 1 Participants |
| Eptinezumab | HCRU Score: Number of Emergency Department Visits Due to Cluster Headache | 2 visits | 1 Participants |
| Eptinezumab | HCRU Score: Number of Emergency Department Visits Due to Cluster Headache | 3 visits | 0 Participants |
| Placebo | HCRU Score: Number of Emergency Department Visits Due to Cluster Headache | 3 visits | 1 Participants |
| Placebo | HCRU Score: Number of Emergency Department Visits Due to Cluster Headache | 0 visits | 99 Participants |
| Placebo | HCRU Score: Number of Emergency Department Visits Due to Cluster Headache | 2 visits | 2 Participants |
| Placebo | HCRU Score: Number of Emergency Department Visits Due to Cluster Headache | 1 visit | 2 Participants |
Secondary
HCRU Score: Number of Hospital Admissions Due to Cluster Headache
Number of participants who were admitted to a hospital due to CH was reported.
Time frame: Week 4
Population: The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure at the specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | HCRU Score: Number of Hospital Admissions Due to Cluster Headache | 0 admissions | 97 Participants |
| Eptinezumab | HCRU Score: Number of Hospital Admissions Due to Cluster Headache | 1 admission | 1 Participants |
| Eptinezumab | HCRU Score: Number of Hospital Admissions Due to Cluster Headache | 2 admissions | 2 Participants |
| Eptinezumab | HCRU Score: Number of Hospital Admissions Due to Cluster Headache | 3 admissions | 0 Participants |
| Placebo | HCRU Score: Number of Hospital Admissions Due to Cluster Headache | 3 admissions | 1 Participants |
| Placebo | HCRU Score: Number of Hospital Admissions Due to Cluster Headache | 0 admissions | 102 Participants |
| Placebo | HCRU Score: Number of Hospital Admissions Due to Cluster Headache | 2 admissions | 1 Participants |
| Placebo | HCRU Score: Number of Hospital Admissions Due to Cluster Headache | 1 admission | 0 Participants |
Secondary
HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache
Number of participants who stayed overnight in a hospital due to CH was reported.
Time frame: Week 4
Population: The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure at the specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache | 0 overnight hospital stays | 99 Participants |
| Eptinezumab | HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache | 5 overnight hospital stays | 1 Participants |
| Placebo | HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache | 0 overnight hospital stays | 104 Participants |
| Placebo | HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache | 5 overnight hospital stays | 0 Participants |
Secondary
HCRU Score: Number of Visits to a Specialist
Number of participants who visited a specialist has been reported.
Time frame: Week 4
Population: The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure at the specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | HCRU Score: Number of Visits to a Specialist | 1 visit | 11 Participants |
| Eptinezumab | HCRU Score: Number of Visits to a Specialist | 3 visits | 4 Participants |
| Eptinezumab | HCRU Score: Number of Visits to a Specialist | 2 visits | 6 Participants |
| Eptinezumab | HCRU Score: Number of Visits to a Specialist | 4 visits | 2 Participants |
| Eptinezumab | HCRU Score: Number of Visits to a Specialist | 0 visits | 77 Participants |
| Placebo | HCRU Score: Number of Visits to a Specialist | 4 visits | 2 Participants |
| Placebo | HCRU Score: Number of Visits to a Specialist | 0 visits | 68 Participants |
| Placebo | HCRU Score: Number of Visits to a Specialist | 1 visit | 18 Participants |
| Placebo | HCRU Score: Number of Visits to a Specialist | 2 visits | 14 Participants |
| Placebo | HCRU Score: Number of Visits to a Specialist | 3 visits | 2 Participants |
Secondary
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner
Number of participants who visited a family doctor/general practitioner has been reported.
Time frame: Week 4
Population: The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure at the specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eptinezumab | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 0 visits | 85 Participants |
| Eptinezumab | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 1 visit | 9 Participants |
| Eptinezumab | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 2 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 3 visits | 3 Participants |
| Eptinezumab | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 5 visits | 1 Participants |
| Eptinezumab | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 6 visits | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 5 visits | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 0 visits | 85 Participants |
| Placebo | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 3 visits | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 1 visit | 10 Participants |
| Placebo | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 6 visits | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | 2 visits | 6 Participants |
Secondary
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1
Time frame: Baseline (Week 0), Week 1
Population: The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eptinezumab | Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1 | 48 Participants |
| Placebo | Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1 | 50 Participants |
Secondary
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
Time frame: Baseline (Week 0), Weeks 1-2
Population: The APRS included all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eptinezumab | Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 | 59 Participants |
| Placebo | Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 | 53 Participants |
Secondary
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1
Time frame: Baseline (Week 0), Week 1
Population: The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eptinezumab | Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1 | 36 Participants |
| Placebo | Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1 | 28 Participants |
Secondary
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
Time frame: Baseline (Week 0), Weeks 1-2
Population: The APRS included all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eptinezumab | Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 | 44 Participants |
| Placebo | Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 | 37 Participants |
Secondary
Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4
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 1, 2, and 4
Population: The APRS included all randomized participants. 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 the specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Eptinezumab | Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4 | Week 2 | 2.92 score on a scale | Standard Error 0.17 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4 | Week 1 | 3.19 score on a scale | Standard Error 0.16 |
| Eptinezumab | Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4 | Week 4 | 2.85 score on a scale | Standard Error 0.18 |
| Placebo | Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4 | Week 1 | 3.55 score on a scale | Standard Error 0.15 |
| Placebo | Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4 | Week 2 | 3.44 score on a scale | Standard Error 0.16 |
| Placebo | Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4 | Week 4 | 3.23 score on a scale | Standard Error 0.17 |
Secondary
Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks
Presented here is the result of the analysis of time from first infusion of IMP to resolution of cluster headache bout. The hazard ratio estimate is an estimate from the Cox model of time to resolution.
Time frame: From first infusion (Baseline, Day 0) to 4 weeks
Population: The APRS included all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eptinezumab | Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks | NA days |
| Placebo | Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks | NA days |
p-value: 0.077295% CI: [0.96, 2.17]Regression, Cox