Eptinezumab in Participants With Episodic Cluster Headache | NCT04688775

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence 1: Eptinezumab Then Placebo	Experimental	Eptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period	Drug: Eptinezumab Drug: Placebo
Sequence 2: Placebo Then Eptinezumab	Experimental	Placebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period	Drug: Eptinezumab Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eptinezumab	Drug	Eptinezumab - concentrate for solution for infusion, intravenously	Sequence 1: Eptinezumab Then Placebo Sequence 2: Placebo Then Eptinezumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline (Week 0), Weeks 1-2

Secondary Outcomes

Measure	Description	Time Frame
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	Abortive medications included the use of triptans or oxygen (O2).

Eligibility Module

Eligibility Criteria

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 exclusion criteria may apply.

Name	Affiliation	Role
Email contact via H. Lundbeck A/S	LundbeckClinicalTrials@Lundbeck.com	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Barrow Neurological Institute		Phoenix	Arizona	85013	United States
Mayo Clinic in Arizona - Phoenix Campus

PubMed Identifier	Type	Citation	Retractions
40388178	Derived	Jensen RH, Tassorelli C, Tepper SJ, Charles A, Goadsby PJ, Snoer AH, Sperling B, Krog Josiassen M, Borgen Linander C, Ettrup A, Boneva N. Efficacy and Safety of Eptinezumab in Episodic Cluster Headache: A Randomized Clinical Trial. JAMA Neurol. 2025 Jul 1;82(7):706-714. doi: 10.1001/jamaneurol.2025.1317.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Eptinezumab	Participants received a single intravenous (IV) infusion of eptinezumab 400 milligrams (mg) in 100 milliliters (mL) 0.9% saline solution.
FG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 3, 2023	Jun 14, 2024

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

The APTS included all randomized participants in the who received infusion with double-blind IMP.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-4.0± 0.93 OG001-4.6± 0.89

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Change From Baseline in the Number of Weekly Attacks: Eptinezumab vs. Placebo	Mixed Models Repeated Measures		0.5048		Mean Difference (Final Values)	0.7			2-Sided	95	-1.3	2.6					Superiority

Secondary

Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2

The APRS included all randomized participants.

Posted

Count of Participants

Participants

Baseline (Week 0), Weeks 1-2

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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).

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Abortive therapy use per week

Baseline (Week 0), Weeks 1-2

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Attacks per day

Baseline (Week 0), Days 1-3

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Days

Baseline (Week 0), Weeks 1-2

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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.

The APRS included all randomized participants.

Posted

Median

95% Confidence Interval

days

From first infusion (Baseline, Day 0) to 4 weeks

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Number of attacks

From first infusion in the placebo-controlled period (Baseline, Day 0) to 24-hours after the first infusion in the placebo-controlled period

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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).

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Week 0), Days 1-3

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 1 in the Number of Weekly Attacks

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Attacks per week

Baseline (Week 0), Week 1

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 2 in the Number of Weekly Attacks

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Attacks per week

Baseline (Week 0), Week 2

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

Secondary

Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

Baseline (Week 0), Week 1

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

Secondary

Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

Baseline (Week 0), Week 1

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

Secondary

Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2

The APRS included all randomized participants.

Posted

Count of Participants

Participants

Baseline (Week 0), Weeks 1-2

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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.

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Week 0), Weeks 1-2

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Secondary

Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Week 0), Week 1

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Secondary

Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Week 0), Week 2

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Secondary

Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Attacks per week

Baseline (Week 0), Weeks 1-4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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.

The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Week 0), Weeks 1-4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

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).

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.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Week 0), Weeks 1, 2, 3, and 4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants

Secondary

Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4

Posted

Least Squares Mean

Standard Error

Attacks per week

Baseline (Week 0), Weeks 3-4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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.

Posted

Least Squares Mean

Standard Error

score on a scale

Weeks 1, 2, and 4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Week 0), Weeks 2 and 4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo

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).

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Week 0), Weeks 2 and 4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
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.

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.

Posted

Count of Participants

Participants

Week 4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

Secondary

HCRU Score: Number of Visits to a Specialist

Number of participants who visited a specialist has been reported.

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.

Posted

Count of Participants

Participants

Week 4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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.

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.

Posted

Count of Participants

Participants

Week 4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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.

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.

Posted

Count of Participants

Participants

Week 4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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.

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.

Posted

Count of Participants

Participants

Week 4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.

Units	Counts
Participants	OG000

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.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Week 0), Week 4

ID	Title	Description
OG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
OG001	Placebo

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo-controlled Period: Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.	112	2	112	10	112
EG001	Placebo-controlled Period: Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.	117	0	117	9	117
EG002	Delayed Start Period: Eptinezumab to Placebo	Participants who received placebo in the placebo-controlled period received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.	108	2	108	13	108
EG003	Delayed Start Period: Placebo to Eptinezumab	Participants who received eptinezumab in the placebo-controlled period received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.	107	1	107	9	107

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaphylactic reaction	Immune system disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected112 at risk EG0010 events0 affected117 at risk EG0020 events0 affected108 at risk EG0031 events1 affected107 at risk
Hypersensitivity	Immune system disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected117 at risk EG0020 events0 affected108 at risk EG003
Meningitis enteroviral	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected112 at risk EG0010 events0 affected117 at risk EG0021 events1 affected108 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected112 at risk EG0010 events0 affected117 at risk EG0021 events1 affected108 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected117 at risk EG0020 events0 affected108 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected112 at risk EG0010 events0 affected117 at risk EG0020 events0 affected108 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected112 at risk EG0013 events2 affected117 at risk EG0024 events3 affected108 at risk EG0030 events0 affected107 at risk
Fatigue	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected112 at risk EG0011 events1 affected117 at risk EG0020 events0 affected108 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected112 at risk EG0013 events3 affected117 at risk EG0027 events7 affected108 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected112 at risk EG0013 events3 affected117 at risk EG0022 events2 affected108 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected112 at risk EG0011 events1 affected117 at risk EG0023 events3 affected108 at risk EG003

ID	Term
D051303	Trigeminal Autonomic Cephalalgias
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Title	Description
BG000	Eptinezumab	Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
BG001	Placebo	Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
BG002	Total	Total of all reporting groups