Phase 3
N=131
A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
Chronic Cluster Headache
Bottom Line
View on ClinicalTrials.gov: NCT05064397 ↗Enrolled (actual)
131
Serious AEs
8.4%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) — 106 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Eptinezumab (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 Number of Participants With Treatment-emergent Adverse Events (AEs) |
106 | — |
| SECONDARY Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 Consecutive Weeks) |
7 | — |
| SECONDARY Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used |
-3.63; -4.24; -4.90; -4.99; -7.22; -6.83 | — |
| SECONDARY Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used |
-1.72; -2.43; -3.17; -3.23; -3.97; -3.93 | — |
| SECONDARY Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used |
-1.75; -1.73; -1.74; -1.90; -2.94; -2.78 | — |
| SECONDARY Change From Baseline in the Average Number of Weekly Attacks |
-3.00; -3.92; -4.51; -4.98; -6.18; -6.31 | — |
| SECONDARY Change From Baseline in the Number of Weekly Attacks |
-3.46 | — |
| SECONDARY Change From Baseline in the Number of Weekly Attacks |
-3.46 | — |
| SECONDARY Change From Baseline in the Number of Monthly Attacks |
-22.65 | — |
| SECONDARY Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale |
-0.47; -0.51; -0.58; -0.59; -0.78; -0.75 | — |
| SECONDARY Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks |
49; 52; 55; 55; 54; 63 | — |
| SECONDARY Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks |
30; 36; 42; 40; 35; 45 | — |
| SECONDARY Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks |
11; 13; 21; 20; 23; 25 | — |
| SECONDARY cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks) |
19 | — |
| SECONDARY cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion) |
8 | — |
| SECONDARY cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Second and Third Infusion) |
10 | — |
| SECONDARY cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion) |
9 | — |
| SECONDARY cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion) |
10 | — |
| SECONDARY Number of Participants Who Received a Transitional Therapy During the Treatment Period |
17 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Score |
2.74; 2.69; 2.69; 2.58; 2.72; 2.58 | — |
| SECONDARY Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time |
14.98; 15.26; 16.36; 15.54; 16.17; 14.51 | — |
| SECONDARY Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 |
0.1; 0.0; -0.2; -0.1; -0.1; 0.1 | — |
| SECONDARY Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48 |
9.03; 9.26; 6.99; 8.61; 6.90 | — |
| SECONDARY Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48 |
-12.03; -8.19; -12.73; -12.05; -5.30; -14.29 | — |
| SECONDARY Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner |
81; 18; 10; 1; 2; 82 | — |
| SECONDARY Health Care Resource Utilization - Number of Visits to a Specialist |
51; 40; 18; 2; 1; 74 | — |
| SECONDARY Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache |
108; 1; 1; 2; 102; 2 | — |
| SECONDARY Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache |
110; 2; 103; 2; 98; 2 | — |
| SECONDARY Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache |
109; 2; 1; 105; 98; 1 | — |
Summary
The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.
Eligibility Criteria
Inclusion Criteria
- The participant has a diagnosis of cCH as defined by International Headache Society (IHS) International Classification of Headache Disorders third edition (ICHD-3) classification with a history of cCH of at least 12 months prior to the Screening Visit.
- The participant has a medical history of onset of cluster headache at ≤50 years of age.
- The participant has an adequately documented record of previous abortive, transitional and preventive medication use for cCH, for at least 12 months prior to the Screening Visit.
- The participant is able to distinguish cluster headache attacks from other headaches (such as tension-type headaches, migraine).
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 chronic tension-type headache, 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 neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or longer than 1 hour).
- Participants with a lifetime history of psychosis, bipolar mania, or dementia. 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.
- The participant has attempted suicide or is, at Screening Visit, at significant risk of suicide.
- The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular 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 (NCT05064397). 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.