Trial · NCT04688775

Eptinezumab in Participants With Episodic Cluster Headache

NCT04688775, Phase 3, Completed, H. Lundbeck A/S; results first posted 2024-08-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Eptinezumab in Participants With Episodic Cluster Headache. Trials, record NCT04688775. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04688775

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Eptinezumab in Participants With Episodic Cluster Headache
NCT number: NCT04688775
Status: Completed
Phases: Phase 3
Enrollment: 231 participants, actual
Lead sponsor: H. Lundbeck A/S
Conditions: Cluster Headache, Episodic
Interventions: Eptinezumab, Placebo
First posted: 2020-12-30
Last updated: 2024-08-09
Results first posted: 2024-08-09

Source ClinicalTrials.gov

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2	Baseline (Week 0), Weeks 1-2
Secondary	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).
Secondary	Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3	Baseline (Week 0), Days 1-3
Secondary	Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2	Baseline (Week 0), Weeks 1-2
Secondary	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.
Secondary	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
Secondary	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).
Secondary	Change From Baseline to Week 1 in the Number of Weekly Attacks	Baseline (Week 0), Week 1
Secondary	Change From Baseline to Week 2 in the Number of Weekly Attacks	Baseline (Week 0), Week 2

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2	Baseline (Week 0), Weeks 1-2	The APRS included all randomized participants.	Number of Weekly Attacks	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2	Baseline (Week 0), Weeks 1-2	The APRS included all randomized participants.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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	The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.	Abortive therapy use per week	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3	Baseline (Week 0), 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.	Attacks per day	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2	Baseline (Week 0), 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.	Days	LEAST_SQUARES_MEAN
SECONDARY	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	The APRS included all randomized participants.	days	MEDIAN
SECONDARY	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	The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.	Number of attacks	LEAST_SQUARES_MEAN
SECONDARY	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 APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 1 in the Number of Weekly Attacks	Baseline (Week 0), Week 1	The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.	Attacks per week	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 2 in the Number of Weekly Attacks	Baseline (Week 0), Week 2	The APRS included all randomized participants. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.	Attacks per week	LEAST_SQUARES_MEAN

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group136

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2	Eptinezumab	-4.0	Standard Error 0.93	Number of Weekly Attacks
Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2	Placebo	-4.6	Standard Error 0.89	Number of Weekly Attacks
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2	Eptinezumab	44		Participants
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2	Placebo	37		Participants
Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2	Eptinezumab	-2.54	Standard Error 0.98	Abortive therapy use per week
Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2	Placebo	-3.55	Standard Error 0.93	Abortive therapy use per week
Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3	Eptinezumab	-0.22	Standard Error 0.16	Attacks per day
Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3	Placebo	-0.35	Standard Error 0.15	Attacks per day
Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2	Eptinezumab	0.60	Standard Error 0.20	Days
Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2	Placebo	0.82	Standard Error 0.19	Days

1 to 10 of 136Source ClinicalTrials.gov

See all 136 results by group

Participant flow32

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Placebo-controlled Period	STARTED	Eptinezumab	113
Placebo-controlled Period	STARTED	Placebo	118
Placebo-controlled Period	STARTED	Delayed Start Period: Placebo to Eptinezumab	0
Placebo-controlled Period	STARTED	Delayed Start Period: Eptinezumab to Placebo	0
Placebo-controlled Period	Received at Least 1 Dose of Study Drug	Eptinezumab	112
Placebo-controlled Period	Received at Least 1 Dose of Study Drug	Placebo	117
Placebo-controlled Period	Received at Least 1 Dose of Study Drug	Delayed Start Period: Placebo to Eptinezumab	0
Placebo-controlled Period	Received at Least 1 Dose of Study Drug	Delayed Start Period: Eptinezumab to Placebo	0
Placebo-controlled Period	COMPLETED	Eptinezumab	108
Placebo-controlled Period	COMPLETED	Placebo	107

1 to 10 of 32Source ClinicalTrials.gov

See all 32 participant flow

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Placebo-controlled Period: Eptinezumab	4	112	4
other	Constipation	Gastrointestinal disorders	Placebo-controlled Period: Placebo	2	117	3
other	Constipation	Gastrointestinal disorders	Delayed Start Period: Eptinezumab to Placebo	3	108	4
other	Constipation	Gastrointestinal disorders	Delayed Start Period: Placebo to Eptinezumab	0	107	0
other	Fatigue	General disorders	Placebo-controlled Period: Eptinezumab	4	112	4
other	Fatigue	General disorders	Placebo-controlled Period: Placebo	1	117	1
other	Fatigue	General disorders	Delayed Start Period: Eptinezumab to Placebo	0	108	0
other	Fatigue	General disorders	Delayed Start Period: Placebo to Eptinezumab	1	107	1
other	COVID-19	Infections and infestations	Placebo-controlled Period: Eptinezumab	1	112	1
other	COVID-19	Infections and infestations	Placebo-controlled Period: Placebo	3	117	3

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo-controlled Period: Eptinezumab	0	112
Total, all-cause mortality	Placebo-controlled Period: Placebo	0	117
Total, all-cause mortality	Delayed Start Period: Eptinezumab to Placebo	0	108
Total, all-cause mortality	Delayed Start Period: Placebo to Eptinezumab	0	107
Total, other adverse events	Placebo-controlled Period: Eptinezumab	10	112
Total, other adverse events	Placebo-controlled Period: Placebo	9	117
Total, other adverse events	Delayed Start Period: Eptinezumab to Placebo	13	108
Total, other adverse events	Delayed Start Period: Placebo to Eptinezumab	9	107
Total, serious adverse events	Placebo-controlled Period: Eptinezumab	2	112
Total, serious adverse events	Placebo-controlled Period: Placebo	0	117

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40388178	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Eptinezumab vs Placebo: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2	Trial comparisons
Eptinezumab vs Placebo: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1	Trial comparisons
Eptinezumab vs Placebo: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1	Trial comparisons
Eptinezumab vs Placebo: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04688775

GET https://conductscience.org/api/trials/v1/NCT04688775/registered?page=2

API reference For AI assistants