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CompletedNCT04688775ALLEVIATEUpdated Aug 9, 2024Results posted

Eptinezumab in Participants With Episodic Cluster Headache

A Phase 3 interventional study of Eptinezumab and Placebo in Cluster Headache, Episodic, sponsored by H. Lundbeck A/S. Completed at 120 sites in 19 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
231
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

Read the 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.

02

Conditions studied

  • Cluster Headache, Episodic

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03

In context

Cluster Headache

123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.

This study's enrollment of 231 is above the median of 42 across 90 interventional studies indexed under Cluster Headache.

Browse Cluster Headache studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Browse H. Lundbeck A/S studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
231 participants (actual)

Study arms

  • Experimental
    Sequence 1: Eptinezumab Then Placebo

    Eptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period

    Drug: Eptinezumab · Drug: Placebo

  • Experimental
    Sequence 2: Placebo Then Eptinezumab

    Placebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period

    Drug: Eptinezumab · Drug: Placebo

Interventions

  • DrugEptinezumab

    Eptinezumab - concentrate for solution for infusion, intravenously

  • DrugPlacebo

    Placebo - 100 milliliters (mL) of 0.9% normal saline, intravenously

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  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).

    Time frame: Baseline (Week 0), Weeks 1-2

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

    Time frame: Baseline (Week 0), Days 1-3

  4. 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

  5. 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

  6. 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

  7. 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

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

    Time frame: Baseline (Week 0), Week 1

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

    Time frame: Baseline (Week 0), Week 2

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

    Time frame: Baseline (Week 0), Week 1

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

    Time frame: Baseline (Week 0), Week 1

  12. 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

  13. 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

  14. 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

  15. 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

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

    Time frame: Baseline (Week 0), Weeks 1-4

  17. 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

  18. 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

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

    Time frame: Baseline (Week 0), Weeks 3-4

  20. 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

  21. 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

  22. 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

  23. 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

  24. HCRU Score: Number of Visits to a Specialist

    Number of participants who visited a specialist has been reported.

    Time frame: Week 4

  25. 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

  26. 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

  27. 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

  28. 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

07

Results

Posted Aug 9, 2024

Participant flow

Placebo-controlled Period
Participant flow — Placebo-controlled Period
MilestoneEptinezumabPlaceboDelayed Start Period: Placebo to EptinezumabDelayed Start Period: Eptinezumab to Placebo
Started11311800
Received at least 1 dose of study drug11211700
Completed10810700
Not completed51100
Withdrew: Randomized, not treated1100
Withdrew: Adverse event2000
Withdrew: Lack of efficacy1200
Withdrew: Protocol violation0100
Withdrew: Withdrawal by subject1600
Withdrew: Other reasons0100
Delayed Start Period
Participant flow — Delayed Start Period
MilestoneEptinezumabPlaceboDelayed Start Period: Placebo to EptinezumabDelayed Start Period: Eptinezumab to Placebo
Started00107108
Received at least 1 dose of study drug00107108
Completed00101100
Not completed0068
Withdrew: Adverse event0010
Withdrew: Lack of efficacy0003
Withdrew: Withdrawal by subject0024
Withdrew: Lost to follow-up0021
Withdrew: Other reasons0010

Outcome measures

PrimaryChange 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
Reported as:
Least squares mean · Number of Weekly Attacks
Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2
Number of Weekly AttacksEptinezumabPlacebo
Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2-4.0 ± 0.93-4.6 ± 0.89
Statistical analysis
  • Eptinezumab vs Placebo · Mixed Models Repeated Measures · p = 0.5048 · Mean difference (final values): 0.7 · 95% CI -1.3 to 2.6
SecondaryNumber of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
Time frame:
Baseline (Week 0), Weeks 1-2
Reported as:
Count of participants · Participants
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
ParticipantsEptinezumabPlacebo
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-24437
SecondaryChange 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
Reported as:
Least squares mean · Abortive therapy use per week
Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2
Abortive therapy use per weekEptinezumabPlacebo
Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2-2.54 ± 0.98-3.55 ± 0.93
SecondaryChange From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3
Time frame:
Baseline (Week 0), Days 1-3
Reported as:
Least squares mean · Attacks per day
Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3
Attacks per dayEptinezumabPlacebo
Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3-0.22 ± 0.16-0.35 ± 0.15
SecondaryChange 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
Reported as:
Least squares mean · Days
Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2
DaysEptinezumabPlacebo
Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-20.60 ± 0.200.82 ± 0.19
SecondaryTime 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
Reported as:
Median · days
Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks
daysEptinezumabPlacebo
Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 WeeksNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Eptinezumab vs Placebo · Regression, Cox · p = 0.0772 · Hazard ratio (hr): 1.45 · 95% CI 0.96 to 2.17
SecondaryChange 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
Reported as:
Least squares mean · Number of attacks
Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP
Number of attacksEptinezumabPlacebo
Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP2.07 ± 0.181.96 ± 0.17
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3
score on a scaleEptinezumabPlacebo
Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3-0.30 ± 0.10-0.18 ± 0.09
SecondaryChange From Baseline to Week 1 in the Number of Weekly Attacks
Time frame:
Baseline (Week 0), Week 1
Reported as:
Least squares mean · Attacks per week
Change From Baseline to Week 1 in the Number of Weekly Attacks
Attacks per weekEptinezumabPlacebo
Change From Baseline to Week 1 in the Number of Weekly Attacks-2.62 ± 0.95-3.71 ± 0.90
SecondaryChange From Baseline to Week 2 in the Number of Weekly Attacks
Time frame:
Baseline (Week 0), Week 2
Reported as:
Least squares mean · Attacks per week
Change From Baseline to Week 2 in the Number of Weekly Attacks
Attacks per weekEptinezumabPlacebo
Change From Baseline to Week 2 in the Number of Weekly Attacks-5.44 ± 1.00-5.64 ± 0.96
SecondaryNumber of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1
Time frame:
Baseline (Week 0), Week 1
Reported as:
Count of participants · Participants
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1
ParticipantsEptinezumabPlacebo
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 13628
SecondaryNumber of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1
Time frame:
Baseline (Week 0), Week 1
Reported as:
Count of participants · Participants
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1
ParticipantsEptinezumabPlacebo
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 14850
SecondaryNumber of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
Time frame:
Baseline (Week 0), Weeks 1-2
Reported as:
Count of participants · Participants
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
ParticipantsEptinezumabPlacebo
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-25953
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2
score on a scaleEptinezumabPlacebo
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2-13.39 ± 2.56-14.46 ± 2.43
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain
score on a scaleEptinezumabPlacebo
Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain-10.58 ± 2.55-11.96 ± 2.42
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain
score on a scaleEptinezumabPlacebo
Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain-16.20 ± 2.73-16.95 ± 2.61
SecondaryChange From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4
Time frame:
Baseline (Week 0), Weeks 1-4
Reported as:
Least squares mean · Attacks per week
Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4
Attacks per weekEptinezumabPlacebo
Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4-5.95 ± 0.92-5.78 ± 0.88
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4
score on a scaleEptinezumabPlacebo
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4-17.81 ± 2.50-16.81 ± 2.37
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
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
score on a scaleEptinezumabPlacebo
Week 1-0.33 ± 0.09-0.24 ± 0.08
Week 2-0.46 ± 0.10-0.35 ± 0.09
Week 3-0.56 ± 0.11-0.31 ± 0.10
Week 4-0.51 ± 0.11-0.42 ± 0.10
SecondaryChange From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4
Time frame:
Baseline (Week 0), Weeks 3-4
Reported as:
Least squares mean · Attacks per week
Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4
Attacks per weekEptinezumabPlacebo
Week 3-7.35 ± 0.98-6.60 ± 0.94
Week 4-8.37 ± 1.11-7.15 ± 1.07
SecondaryPatient 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
Reported as:
Least squares mean · score on a scale
Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4
score on a scaleEptinezumabPlacebo
Week 13.19 ± 0.163.55 ± 0.15
Week 22.92 ± 0.173.44 ± 0.16
Week 42.85 ± 0.183.23 ± 0.17
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
score on a scaleEptinezumabPlacebo
Daily Activities - Week 216.83 ± 3.088.93 ± 3.06
Daily Activities - Week 424.82 ± 3.1913.97 ± 3.08
Emotional Well-being - Week 214.85 ± 2.846.04 ± 2.81
Emotional Well-being - Week 422.77 ± 3.0712.22 ± 2.97
Energy/Fatigue - Week 218.16 ± 3.238.03 ± 3.19
Energy/Fatigue - Week 424.16 ± 3.4714.68 ± 3.36
Mental Fatigue - Week 29.04 ± 2.664.15 ± 2.64
Mental Fatigue - Week 415.15 ± 2.918.00 ± 2.81
Emotional Impact - Week 214.39 ± 3.026.00 ± 3.00
Emotional Impact - Week 423.09 ± 3.2913.36 ± 3.18
Social Well-being - Week 215.22 ± 3.376.92 ± 3.35
Social Well-being - Week 423.74 ± 3.4613.91 ± 3.35
Satisfaction with Sleep - Week 2-11.41 ± 2.75-6.06 ± 2.73
Satisfaction with Sleep - Week 4-19.60 ± 2.88-9.63 ± 2.78
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4
score on a scaleEptinezumabPlacebo
Week 28.21 ± 2.793.47 ± 2.86
Week 413.49 ± 2.805.73 ± 2.77
SecondaryHealth 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
Reported as:
Count of participants · Participants
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner
ParticipantsEptinezumabPlacebo
0 visits8585
1 visit910
2 visits16
3 visits31
5 visits11
6 visits11
SecondaryHCRU Score: Number of Visits to a Specialist

Number of participants who visited a specialist has been reported.

Time frame:
Week 4
Reported as:
Count of participants · Participants
HCRU Score: Number of Visits to a Specialist
ParticipantsEptinezumabPlacebo
0 visits7768
1 visit1118
2 visits614
3 visits42
4 visits22
SecondaryHCRU 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
Reported as:
Count of participants · Participants
HCRU Score: Number of Emergency Department Visits Due to Cluster Headache
ParticipantsEptinezumabPlacebo
0 visits9899
1 visit12
2 visits12
3 visits01
SecondaryHCRU 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
Reported as:
Count of participants · Participants
HCRU Score: Number of Hospital Admissions Due to Cluster Headache
ParticipantsEptinezumabPlacebo
0 admissions97102
1 admission10
2 admissions21
3 admissions01
SecondaryHCRU 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
Reported as:
Count of participants · Participants
HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache
ParticipantsEptinezumabPlacebo
0 overnight hospital stays99104
5 overnight hospital stays10
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4
score on a scaleEptinezumabPlacebo
Absenteeism-13.71 ± 3.95-4.37 ± 3.74
Presenteeism-19.29 ± 4.81-11.03 ± 4.68
Work productivity loss-23.59 ± 5.34-13.68 ± 5.20
Activity impairment-25.84 ± 3.70-15.82 ± 3.58

Adverse events

Collected over From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo-controlled Period: Eptinezumab0/112 (0%)2/112 (1.8%)10/112 (8.9%)
Placebo-controlled Period: Placebo0/117 (0%)0/117 (0%)9/117 (7.7%)
Delayed Start Period: Eptinezumab to Placebo0/108 (0%)2/108 (1.9%)13/108 (12%)
Delayed Start Period: Placebo to Eptinezumab0/107 (0%)1/107 (0.9%)9/107 (8.4%)
Most frequent serious events
Most frequent serious events
EventPlacebo-controlled Period: EptinezumabPlacebo-controlled Period: PlaceboDelayed Start Period: Eptinezumab to PlaceboDelayed Start Period: Placebo to Eptinezumab
Anaphylactic reactionImmune system disorders0/1120/1170/1081/107
Meningitis enteroviralInfections and infestations0/1120/1171/1080/107
Bladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1120/1171/1080/107
HypersensitivityImmune system disorders1/1120/1170/1080/107
Urinary incontinenceRenal and urinary disorders1/1120/1170/1080/107
CystoceleReproductive system and breast disorders1/1120/1170/1080/107
Most frequent other events
Most frequent other events
EventPlacebo-controlled Period: EptinezumabPlacebo-controlled Period: PlaceboDelayed Start Period: Eptinezumab to PlaceboDelayed Start Period: Placebo to Eptinezumab
COVID-19Infections and infestations1/1123/1177/1082/107
NasopharyngitisInfections and infestations2/1123/1172/1086/107
ConstipationGastrointestinal disorders4/1122/1173/1080/107
FatigueGeneral disorders4/1121/1170/1081/107
Urinary tract infectionInfections and infestations0/1121/1173/1080/107

Baseline characteristics

The all-participants-randomized-set (APRS) included all randomized participants. The all-participants-treated set (APTS) included all randomized participants who received infusion with double-blind investigational medicinal product (IMP). Demographic characteristics were collected for the APTS and study-specific characteristics were collected for the APRS.

Age, Continuous
Age, Continuous(years)EptinezumabPlaceboTotal
Mean44.17 ± 11.09943.94 ± 11.01944.05 ± 11.035
Sex: Female, Male
Sex: Female, Male(Participants)EptinezumabPlaceboTotal
Female272451
Male8593178
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)EptinezumabPlaceboTotal
American Indian or Alaska Native000
Asian448
Native Hawaiian or Other Pacific Islander000
Black or African American101
White97103200
Other123
Unknown or Not Reported9817
Number of Weekly Cluster Headache (CH) Attacks
Number of Weekly Cluster Headache (CH) Attacks(Number of Weekly Attacks)EptinezumabPlaceboTotal
Mean15.2 ± 8.0715.7 ± 8.2815.4 ± 8.17
08

Study locations

120 sites
  • Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
  • Mayo Clinic in Arizona - Phoenix Campus
    Phoenix, Arizona 85054, United States
  • Keck School of Medicine of USC
    Los Angeles, California 90033, United States
  • Clinical Research Institute
    Los Angeles, California 90048, United States
  • Stanford Neurosciences Health Center
    Palo Alto, California 94304, United States
  • Neurology Colorado - Denver Advanced Neurological Evaluation and Treatment Center
    Denver, Colorado 80218, United States
  • Yale New Haven Hospital
    New Haven, Connecticut 06510-2483, United States
  • New England Institute for Neurology and Headache
    Stamford, Connecticut 06905, United States
  • Accel Research Sites - Tampa
    Tampa, Florida 33634, United States
  • Diamond Headache Clinic
    Chicago, Illinois 60642, United States
  • Michigan Headache and Neurological Institute
    Ann Arbor, Michigan 48104-5131, United States
  • Mayo Clinic - Rochester
    Rochester, Minnesota 55905, United States
  • The Headache Center Mississippi
    Ridgeland, Mississippi 39157, United States
  • Clinvest Research
    Springfield, Missouri 65810, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Dent Neurologic Institute - Amherst
    Amherst, New York 14226, United States
  • New York University School of Medicine
    New York, New York 10016, United States
  • Headache Wellness Center
    Greensboro, North Carolina 27405, United States
  • Cleveland Clinic - Neurological Institute
    Cleveland, Ohio 44195, United States
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
  • Hightower Clinical
    Oklahoma City, Oklahoma 73134, United States
  • Thomas Jefferson University Hospital - Center City Campus
    Philadelphia, Pennsylvania 19107, United States
  • Mischer Neuroscience Institute
    Houston, Texas 77030, United States
  • Froedtert and Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • Universitair Ziekenhuis Brussel
    Brussels, Bruxelles-Capitale 1090, Belgium
  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
    Brugge, West-Vlaanderen 8000, Belgium
  • Centre Hospitalier Chretien - Clinique MontLégia
    Liège, 4000, Belgium
  • Mestska Nemocnice Ostrava
    Ostrava, Moravian-Silesian 728 80, Czechia
  • Fakultní Thomayerova nemocnice
    Praha 4, Prague 140 59, Czechia
  • FORBELI s.r.o. Neurologicka Ambulance
    Praha 6, Prague 160 00, Czechia
  • Institut Neuropsychiatrické Péce
    Praha 8, Prague 186 00, Czechia
  • Rigshospitalet Glostrup
    Glostrup, Hovedstaden 2600, Denmark
  • Aarhus Universitetshospital
    Aarhus N, Midtjylland 8200, Denmark
  • Hospitalsenhed Midt og Regionshospitalet Viborg
    Viborg, Midtjylland 8800, Denmark
  • Sydvestjysk Sygehus - Esbjerg
    Esbjerg, 6700, Denmark
  • Confido Meditsiinikeskus
    Tallinn, Harjumaa 10138, Estonia
  • Ida-Viru Keskhaigla
    Kohtla-Järve, Ida-Virumaa 31025, Estonia
  • Tartu Ülikooli Kliinikum
    Tartu, Tartumaa 50406, Estonia
  • Tampereen Yliopistollinen Sairaala (TAYS)
    Tampere, Länsi-Suomen Lääni 33520, Finland
  • Terveystalo Ruoholahti
    Helsinki, Southern Finland 00180, Finland
  • Terveystalo Turku Pulssi
    Turku, Western Finland 20100, Finland
  • Terveystalo Tampere
    Tampere, 33100, Finland
  • Centre Hospitalier Universitaire de Clermont-Ferrand
    Clermont-Ferrand Cedex 1, Auvergne-Rhône-Alpes 63003, France
  • Hôpital Cimiez
    Nice Cedex 1, Côte-d'Or 91179 - 06003, France
  • Hôpital Roger Salengro
    Lille, Nord 59037, France
  • Hôpital de la Timone
    Marseille Cedex 5, Provence Alpes Cote d'Azur 13005, France
  • Centre Hospitalier Annecy Genevois
    Metz-Tessy, Rhone-Alpes 74370, France
  • Centre Hospitalier Universitaire de Saint-Étienne
    Saint-Priest-en-Jarez, Rhône 42055, France
  • Hôpital Pierre Wertheimer
    Bron, France
  • Hôpital Lariboisière
    Paris, Île-de-France 75010, France
  • Pineo Medical Ecosystem
    Tbilisi, 0114, Georgia
  • Archangel Saint Michael Multiprofile Clinical Hospital
    Tbilisi, 0159, Georgia
  • Aversi Clinic - Central Branch
    Tbilisi, 0160, Georgia
  • Simon Khechinashvili University Hospital
    Tbilisi, 0179, Georgia
  • Consilium Medulla Multiprofile Clinic
    Tbilisi, 0186, Georgia
  • Universität Heidelberg
    Heidelberg, Baden-Württemberg 69120, Germany
  • LMU Klinikum - Campus Grosshadern
    München, Bayern D-81377, Germany
  • Kopfschmerzzentrum Frankfurt
    Frankfurt/ Main, Hessen 65929, Germany
  • Universitätsmedizin Rostock
    Rostock, Mecklenburg-Western-Pommerania 18147, Germany
  • Neurologische Praxis Dr. Stude
    Bochum, Nordrhein-Westfalen 44787, Germany
  • Praxis für Neurologie, Psychosomatik, Nervenheilkunde, Psychotherapie und Spezielle Schmerztherapie
    Essen, Nordrhein-Westfalen 45133, Germany
  • Universitätsklinikum Essen
    Essen, Nordrhein-Westfalen 45147, Germany
  • Universitatsklinikum Carl Gustav Carus Dresden
    Dresden, Sachsen 01307, Germany
  • Schmerzklinik Kiel
    Kiel, Schleswig-Holstein 24149, Germany
  • Charité Campus Mitte
    Berlin, 10117, Germany
  • Eginition University - General Hospital of Athens
    Athens, Attica 11528, Greece
  • 401 General Military Hospital of Athens
    Athina, Attica 115 25, Greece
  • Mediterraneo Hospital
    Glyfada, Attica 16675, Greece
  • University General Hospital of Larissa
    Larissa, Thessaly 41110, Greece
  • General Hospital of Patras Agios Andreas
    Patra, Western Greece 263 32, Greece
  • Euromedica General Clinic - Thessaloniki
    Thessaloniki, 54645, Greece
  • Azienda Ospedaliero - Universitaria Careggi
    Firenze, Florence 50134, Italy
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
    Rome, Roma 00163, Italy
  • Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
    Bari, 70124, Italy
  • IRCCS Istituto Delle Scienze Neurologiche di Bologna
    Bologna, 40123, Italy
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...
    Milano, 20133, Italy
  • Azienda Ospedaliero - Universitaria di Modena
    Modena, 41124, Italy
  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
    Napoli, 280138, Italy
  • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
    Pavia, 27100, Italy
  • Universita Campus Bio-Medico di Roma
    Rome, 00128, Italy
  • Ospedale Molinette - Clinica Neurologica II - Centro Cefalee
    Turin, 10126, Italy
  • Sendai Headache And Neurology Clinic
    Sendai-shi, Miyagi 982-0014, Japan
  • Saitama Neuropsychiatric Institute
    Saitama-shi, Saitama 338-8577, Japan
  • Japanese Red Cross Shizuoka Hospital
    Shizuoka-shi, Shizuoka 420-0853, Japan
  • Canisius-Wilhelmina Ziekenhuis
    Nijmegen, Gelderland 6532 SZ, Netherlands
  • Zuyderland Medisch Centrum Sittard-Geleen
    Geleen, Limburg 6162 BG, Netherlands
  • Brain Research Center - Amsterdam
    Amsterdam, Noord-Holland 1081 GN, Netherlands
  • Oslo Hodepinesenter
    Oslo, 0275, Norway
  • St. Olavs Hospital - Universitetssykehuset I Trondheim
    Trondheim, 7030, Norway
  • Hospital Prof. Doutor Fernando Fonseca
    Amadora, Lisboa 2720-276, Portugal
  • Centro Hospitalar Universitario Lisboa Norte, E.P.E - Hospital De Santa Maria
    Lisbon, Lisboa 1649-035, Portugal
  • Hospital Garcia de Orta
    Almada, Setúbal 2805-267, Portugal
  • Hospital da Luz
    Lisboa, 1500-650, Portugal
  • City Hospital No. 33 of the Leninsky District of the city of Nizhny Novgorod
    Nizhnij Novgorod, Nizhegorodskaya Oblast 603076, Russian Federation
  • Perm State Medical University named after E. A. Wagner of the Ministry of Healthcare of the Russi...
    Perm, Permsky 614990, Russian Federation
  • Kazan State Medical University
    Kazan, Tartarstan 420012, Russian Federation
  • First Moscow State Medical University named after I.M. Sechenov
    Moscow, 119146, Russian Federation
  • University Headache Clinic
    Moscow, 121467, Russian Federation
  • LLC Scientific and Practical Medical Center Innovation and Health
    Novosibirsk, 630054, Russian Federation
  • Hospital Universitario Marques de Valdecilla
    Santander, Cantabria 39008, Spain

Showing the first 100 of 120 sites across 19 countries. Choose a country and city above to see the rest.

09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04688775
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Dec 30, 2020
Start date
Dec 23, 2020
Primary completion
Jun 14, 2023
Completion
Oct 5, 2023
Results posted
Aug 9, 2024
Last update
Aug 9, 2024

Study contacts

Email contact via H. Lundbeck A/S
study director · LundbeckClinicalTrials@Lundbeck.com

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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