Phase 3
N=231
Eptinezumab in Participants With Episodic Cluster Headache
Cluster Headache, Episodic
Bottom Line
View on ClinicalTrials.gov: NCT04688775 ↗Enrolled (actual)
231
Serious AEs
1.1%
Results posted
Aug 2024
Primary outcome: Primary: Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2 — -4.0; -4.6 Number of Weekly Attacks — p=0.5048
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Eptinezumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lundbeck A/S
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2 |
-4.0; -4.6 | 0.5048 |
| SECONDARY Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 |
44; 37 | — |
| SECONDARY Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2 |
-2.54; -3.55 | — |
| SECONDARY Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3 |
-0.22; -0.35 | — |
| SECONDARY Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2 |
0.60; 0.82 | — |
| SECONDARY Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks |
NA; NA | 0.0772 |
| SECONDARY Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP |
2.07; 1.96 | — |
| SECONDARY Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3 |
-0.30; -0.18 | — |
| SECONDARY Change From Baseline to Week 1 in the Number of Weekly Attacks |
-2.62; -3.71 | — |
| SECONDARY Change From Baseline to Week 2 in the Number of Weekly Attacks |
-5.44; -5.64 | — |
| SECONDARY Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1 |
36; 28 | — |
| SECONDARY Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1 |
48; 50 | — |
| SECONDARY Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 |
59; 53 | — |
| SECONDARY Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2 |
-13.39; -14.46 | — |
| SECONDARY Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain |
-10.58; -11.96 | — |
| SECONDARY Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain |
-16.20; -16.95 | — |
| SECONDARY Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4 |
-5.95; -5.78 | — |
| SECONDARY Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4 |
-17.81; -16.81 | — |
| 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 |
-0.33; -0.24; -0.46; -0.35; -0.56; -0.31 | — |
| SECONDARY Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4 |
-7.35; -6.60; -8.37; -7.15 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4 |
3.19; 3.55; 2.92; 3.44; 2.85; 3.23 | — |
| SECONDARY Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 |
16.83; 8.93; 24.82; 13.97; 14.85; 6.04 | — |
| SECONDARY Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4 |
8.21; 3.47; 13.49; 5.73 | — |
| SECONDARY Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner |
85; 85; 9; 10; 1; 6 | — |
| SECONDARY HCRU Score: Number of Visits to a Specialist |
77; 68; 11; 18; 6; 14 | — |
| SECONDARY HCRU Score: Number of Emergency Department Visits Due to Cluster Headache |
98; 99; 1; 2; 1; 2 | — |
| SECONDARY HCRU Score: Number of Hospital Admissions Due to Cluster Headache |
97; 102; 1; 0; 2; 1 | — |
| SECONDARY HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache |
99; 104; 1; 0 | — |
| SECONDARY Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 |
-13.71; -4.37; -19.29; -11.03; -23.59; -13.68 | — |
Summary
The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)
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.
Data sourced from ClinicalTrials.gov (NCT04688775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.