Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache

H. Lundbeck A/S31 sites in 9 countries131 target enrollmentSeptember 17, 2021

ConditionsChronic Cluster Headache

InterventionsEptinezumab

DrugsEptinezumab

Overview

Phase: Phase 3
Intervention: Eptinezumab
Conditions: Chronic Cluster Headache
Sponsor: H. Lundbeck A/S
Enrollment: 131
Locations: 31
Primary Endpoint: Number of Participants With Treatment-emergent Adverse Events (AEs)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

Detailed Description

The participants who take part in this trial will be asked to stay in the trial for about a year. The participants will be asked to visit the trial site 7 times during the trial. In between trial site visits, they will have scheduled phone calls with the trial site staff. They will also be asked to keep track of their cluster headaches at home with a headache diary.

Registry

clinicaltrials.gov

Start Date

September 17, 2021

End Date

June 29, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Responsible Party

Sponsor

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.

Arms & Interventions

Eptinezumab

Participants will receive 4 intravenous (IV) infusions with eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.

Intervention: Eptinezumab

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events (AEs)

Time Frame: From the day of first dose of study drug (Baseline [Week 0]) up to Week 56

A treatment-emergent AE was defined as any on-treatment untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Secondary Outcomes

Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used(Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40)
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(Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40)
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks(Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40)
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks)(Week 1 to Week 48)
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion)(Week 1 to Week 12)
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used(Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40)
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used(Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40)
Number of Participants Who Received a Transitional Therapy During the Treatment Period(Week 1 to Week 48)
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner(Baseline (Week 0), Weeks 4, 16, 28, 40, 48)
Health Care Resource Utilization - Number of Visits to a Specialist(Baseline (Week 0), Weeks 4, 16, 28, 40, 48)
Change From Baseline in the Average Number of Weekly Attacks(Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40)
Change From Baseline in the Number of Weekly Attacks(Baseline (Week 0), Weeks 1-2)
Change From Baseline in the Number of Monthly Attacks(Baseline (Week 0), Months 1-12)
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Second and Third Infusion)(Week 13 to Week 24)
Patient Global Impression of Change (PGIC) Score(Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48)
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)(Week 1 to Week 48)
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion)(Week 25 to Week 36)
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48(Baseline (Week 0), Weeks 4, 16, 28, 40, 48)
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache(Baseline (Week 0), Weeks 4, 16, 28, 40, 48)
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks(Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40)
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks(Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40)
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)(Week 37 to Week 48)
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48(Baseline (Week 0), Weeks 4, 16, 28, 40, 48)
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache(Baseline (Week 0), Weeks 4, 16, 28, 40, 48)
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(Baseline (Week 0), Weeks 4, 16, 28, 40, 48)
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache(Baseline (Week 0), Weeks 4, 16, 28, 40, 48)
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time(Baseline (Week 0), Weeks 4, 12, 16, 24, 28, 36, 40, 48)