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Eptinezumab in Participants With Episodic Cluster Headache (ALLEVIATE)

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ClinicalTrials.gov Identifier: NCT04688775
Recruitment Status : Completed
First Posted : December 30, 2020
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Cluster Headache, Episodic Drug: Eptinezumab Drug: Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Delayed-Start Study to Evaluate the Efficacy and Safety of Eptinezumab in Patients With Episodic Cluster Headache
Actual Study Start Date : December 23, 2020
Actual Primary Completion Date : June 14, 2023
Actual Study Completion Date : October 5, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequence 1: Eptinezumab Then Placebo
Eptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period
 Drug: Eptinezumab
Eptinezumab - concentrate for solution for infusion, intravenously

Drug: Placebo
Placebo - 100 milliliters (mL) of 0.9% normal saline, intravenously
Experimental: Sequence 2: Placebo Then Eptinezumab
Placebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period
 Drug: Eptinezumab
Eptinezumab - concentrate for solution for infusion, intravenously

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


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-2 [ Time Frame: Baseline, Weeks 1-2 ]

Secondary Outcome Measures :
  1. Percentage of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 [ Time Frame: Baseline, Weeks 1-2 ]
  2. Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2 [ Time Frame: Baseline, Weeks 1-2 ]
  3. Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3 [ Time Frame: Baseline, 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, Weeks 1-2 ]
  5. Time From First Infusion of Investigation Medicinal Product (IMP) to Resolution of Cluster Headache Bout Within the First 4 Weeks [ Time Frame: From Baseline to Week 4 ]
  6. Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP [ Time Frame: From first infusion (Day 0) to 24-hours post infusion ]
  7. Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3 [ Time Frame: Baseline, Days 1-3 ]
  8. Change From Baseline in the Number of Weekly Attacks to Week 1 [ Time Frame: Baseline, Week 1 ]
  9. Change From Baseline in the Number of Weekly Attacks to Week 2 [ Time Frame: Baseline, Week 2 ]
  10. Percentage of Participants With ≥50% Reduction From Baseline in Number of Attacks in Week 1 [ Time Frame: Baseline, Week 1 ]
  11. Percentage of Participants With ≥30% Reduction From Baseline in Number of Attacks in Week 1 [ Time Frame: Baseline, Week 1 ]
  12. Percentage of Participants With ≥30% Reduction in Number of Weekly Attacks Over Weeks 1-2 [ Time Frame: Baseline, Weeks 1-2 ]
  13. Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of pain, Averaged Over Weeks 1-2 [ Time Frame: Baseline, Weeks 1-2 ]
    For each week add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.

  14. Change From Baseline to Week 1 in Integrated Measure of Frequency and Intensity of Pain [ Time Frame: Baseline, Week 1 ]
    For Week 1 add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.

  15. Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain [ Time Frame: Baseline, Week 2 ]
    For Week 2 add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.

  16. Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4 [ Time Frame: Baseline, Weeks 1-4 ]
  17. Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain (Weeks 1-4) [ Time Frame: Baseline, Weeks 1-4 ]
    For each week add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.

  18. Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Week) for Weeks 1, 2, 3, and 4 [ Time Frame: Baseline, Weeks 1, 2, 3, and 4 ]
  19. Change From Baseline in Number of Attacks for Weeks 3-4 [ Time Frame: Baseline, Weeks 3-4 ]
  20. Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4 [ Time Frame: Weeks 1, 2, and 4 ]
  21. Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, Weeks 2 and 4 ]
  23. Health Care Resource Utilization (HCRU) Score at Week 4 [ Time Frame: Week 4 ]
  24. Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Score at Week 4 [ Time Frame: Baseline, Week 4 ]
    General Health second version (WPAI:GH2.0) sub-scores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688775


Locations
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Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
More Information
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04688775    
Other Study ID Numbers: 19386A
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: November 7, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
 Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases